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FDA Approves Dsuvia for Treating Acute Pain

News that the FDA approved Dsuvia, an opioid 5 to 10 times more potent than fentanyl, at the end of 2018 has made headlines across the country. This had led to a huge uproar among the community, as many believe that this prescription drug will only worsen the opioid epidemic that the country is facing. https://www.youtube.com/embed/yG8zr0L3wtk There are differing opinions among the medical community. Some doctors and specialists agree with the public opinion that this prescription opioid may make things worse. Other professionals believe that Dsuvia is unique and able to accomplish things that other prescription opioids cannot at this time. They claim that there is quite a lot of barriers in place to prevent this drug from getting abused. We’ll explore both sides of the argument, so you can make an informed decision of your own about this latest controversy.

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What Is Dsuvia?

The active ingredient in Dsuvia is sufentanil. It comes in a 30 microgram tablet in a single-dose applicator. This packaging design is to eliminate the risks of misuse and abuse. This prescription opioid is to be placed under the tongue where it will slowly dissolve. Dsuvia tablets also contain certain inactive ingredients, like mannitol, hypromellose, dicalcium phosphate anhydrous, stearic acid, croscarmellose sodium, FD&C Blue #2 and magnesium stearate. Inactive ingredients won’t have much of an effect on the body. How does this drug measure up to other prescription opioids? It is 5 to 7 times more potent than fentanyl, and over 500 times more potent than morphine. Since this drug involves a sublingual administration, it’s great for patients who have a nothing by mouth (NPO) status or for those who cannot easily obtain intravenous opioids. This opioid is also ideal for those who are obese and elderly, as well as burn victims and needle-phobic patients.

The History of Sufentanil and How Is It Different from Other Opioids

The active ingredient sufentanil is not new to the pharmaceutical industry. Sufentanil is an opioid analgesic that is used as an IV analgesia and anesthesia to treat moderate to severe pain. It has a short duration of action. It can easily cross the blood-brain barrier and can reach peak plasma levels within 6 minutes. On top of being incredibly potent, there are some main differences between sufentanil and other opioids, like morphine or fentanyl. Some of these differences include:

  • Not having any active metabolites. This is a good thing, as active metabolites can prolong the effects of the opioid. Some patients may even find that active metabolites may accumulate in their system.
  • Noninvasive administration. Since no IV is needed, this drug is easy to administer. It also has a high therapeutic index.
  • Quick administration times. Dsuvia is rapidly absorbed by the body through the transmucosal pathway. This is better than being absorbed from the gastrointestinal tract, as this type of absorption can lead to erratic and delayed timing.

Sufentanil is quite different from other opioids. It has a lot of potential in comparison to other opioids.

How Does Dsuvia Work in the Body

Dsuvia works by binding to G-protein receptors in the central nervous system (CNS). This drug works by causing GTP to be exchanged for GP. It also lowers intracellular cAMP levels. Sufentanil does this by inhibiting adenylate cyclase and the following neurochemicals:

  • Acetylcholine
  • Dopamine
  • GABA
  • Glucagon
  • Insulin
  • Noradrenaline
  • Somatostatin
  • Substance P
  • Vasopressin

Dsuvia open calcium-dependent channels. All of these activities cause the brain cells to become hyperpolarized. This reduces neuronal excitability.

What Are the Merits of Sufentanil?

Advancements in military technology have resulted in thousands of severely wounded military personnel. 80% of injured personnel are transported away from the battlegrounds with uncontrolled pain. There simply is no means available for relieving the pain.   Currently, 55% of all opioids administered on the battlefield are done so through intravenous means. However, not everyone has access to intravenous opioids. These individuals may also not be capable of swallowing pills or tablets depending on their condition. This means that many military personnel is left without any means of relieving their pain. They have to suffer through it all. Intense pain can lead to tachycardia, sleep disturbances, pulmonary complications, increased stress, and other issues. It may also lead to worsening PTSD. It’s vital that these individuals get the help that they need immediately. With the approval of Dsuvia, injured military personnel will get a high dose of pain pills without having to swallow or without having to be near medical equipment capable of administering intravenous opioids. These individuals will quickly get the pain relief that they need in an effective manner. According to AcelRx, Dsuvia was used in a double-blind placebo-controlled study. This study involved 161 patients between the ages of 18 to 69. Those who took Dsuvia experienced meaningful pain relief within 15 minutes.

Dsuvia and the Human Body

Dsuvia is a powerful drug that can have an effect on many critical systems in the human body. This prescription drug effects:

  • The cardiovascular system. Sufentanil may cause vasodilation.
  • The central nervous system by directly acting and interacting with the brainstem respiratory centers. This can lead to an increase in carbon dioxide tension and electrical stimulation.
  • The endocrine system. Many hormone levels get out of whack when Dsuvia is taken. Many studies suggest that this drug will cause cortisol, adrenocorticotropic hormone (ACTH) and luteinizing hormone (LH) levels to fluctuate.
  • The gastrointestinal tract by reducing overall motility. This drug negatively impacts smooth muscle tone.
  • The immune system. Various studies have shown that Dsuvia may have immunosuppressive qualities. This may cause the patient to be more at risk of infections and other diseases.
  • The respiratory system. This is most apparent with overdoses. An overdose can quickly lead to respiratory depression.

This prescription opioid is quite versatile and can have a profound impact on the human body. Due to this reason, doctors must first weigh out the pros and cons before administering this drug.

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How Is Dsuvia Administered

Dsuvia is a sublingual tablet comes in pre-packaged doses of 30mcg. This prescription drug comes in a single-dose applicator and can be administered as needed with a minimum of 1 hour between doses. Doctors should also not exceed 12 tablets within a span of 24 hours. The single-dose applicator is fairly easy to use. Instructions:

  1. Open the notched pouch at the top of the applicator and discard the oxygen absorber packet
  2. Squeeze the side of the applicator to remove the white lock and detach the dispenser
  3. Rest the applicator lightly on the patients’ lower teeth or lips and have them touch their tongue to the roof of their mouth
  4. Press on the dispenser while aiming it at the floor of the patients’ mouths
  5. Check to confirm that the tablet is placed in the sublingual space

Patients should let the tablet dissolve naturally. They should not attempt to chew or swallow the tablet. They also should not eat, drink or talk for 10 minutes after the drug is administered. Do not use this prescription drug is the seal is broken or if the applicator is damaged. Medical professionals administering this drug should wear gloves.

Drug Interactions with Dsuvia

Patients who are prescribed Dsuvia should let a doctor know if they are taking any other prescription drugs, as unwanted drug interactions may occur. Patients may need to stop taking the drugs prescribed or may need to be under more intense supervision. Some prescription medications that may interact with sufentanil include:

  • Anticholinergic drugs, like Parkinson’s medications. Use of these drugs with sufentanil may lead to an increased risk of urinary retention and constipation. This may then lead to paralytic ileus, which is basically obstruction of the intestines.
  • Benzodiazepines and other Central Nervous System (CNS) depressants. Concurrent use of both substances can lead to an increased risk of respiratory depression, hypotension, sedation, coma, and death.
  • CYP3A4 inhibitors, like cimetidine, fluconazole, and ritonavir. These drugs may increase the concentration of sufentanil in the plasma. This can cause the drug to have a longer effect on the body. It can also lead to decreased efficacy or more intense withdrawal symptoms.
  • CYP3A4 inducers, like rifampin, carbamazepine, and phenytoin. These drugs can lower plasma concentrations and lead to decreased efficacy. Use of both a CYP3A4 inducer and Dsuvia can lead to an increased risk of respiratory depression.
  • Monoamine Oxidase Inhibitors (MAOIs), like phenelzine. Drug interactions may manifest as opioid toxicity.
  • Muscle relaxants. Patients may be at a greater risk of respiratory depression as Dsuvia enhances neuromuscular blocking activity.
  • Serotonergic drugs, like selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs). This leads to an increased risk of serotonin syndrome.

Understanding potential drug interactions between Dsuvia and other substances is crucial. Medical professionals should be well aware of a patient’s medical history before prescribing this opioid.

Adverse Reactions and Side Effects to Be Aware Of

Much like with all substances, the use of Dsuvia may lead to some adverse reactions and unsavory side effects. Knowing what to expect is crucial. Those who are considering whether or not they should take this drug will need to know what the risks of taking it may be. Only a handful of patients taking Dsuvia experienced any adverse reactions and side effects. The same study found that patients taking placebo medications may also experience the same reactions. Some common adverse reactions and side effects associated with Dsuvia use include:

  • Addiction, abuse, and misuse
  • Adrenal insufficiency
  • Cardiac disorders, like bradycardia
  • Dizziness
  • Gastrointestinal reactions, like flatulence, constipation and abdominal discomfort
  • Hemiparesis
  • Life-threatening respiratory depression
  • Musculoskeletal disorders like muscle spasms
  • Nausea
  • Neonatal opioid withdrawal syndrome
  • Nervous system disorders like somnolence and lethargy
  • Psychiatric disorders like insomnia increased anxiety and agitation
  • Renal disorders like urinary retention and renal failure
  • REspiratory disorders like apnea and hypoxia
  • Seizures
  • Severe hypotension
  • Skin tissue disorders like rashes
  • Vascular disorders like orthostatic hypotension, hypertension, and flushing

1 out of 107 patients will usually discontinue Dsuvia use due to the side effects or adverse reactions experienced. These patients may wish to switch to another drug or may wish to simply stop taking Dsuvia completely. Those who decide that they’d like to stop taking Dsuvia completely must be careful. It can take some time for the drug to be cleared from their system. Those who experience any adverse reactions or side effects should speak with their doctor immediately. This prescription opioid may not be compatible with their system.

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The Timeline that Led to the Approval of Dsuvia

It took over 2 years for the FDA to finally approve Dsuvia. This is because this drug had to go through rigorous testing. The FDA had to confirm that this prescription opioid was safe for medical use. The paperwork for the FDA approval process also takes some time.

  • Dec 13, 2016. AcelRx submits a New Drug Application (NDA) for Dsuvia. This application contains complete information on four clinical trials where this drug was used as a treatment for moderate-to-severe pain.
  • Jan 8, 2017. AcelRx provides the public with more information on 2017 milestones.
  • Feb 27, 2017. The FDA accepts the NDA for filing.
  • October 12, 2017. AcelRx receives a Complete Response Letter (CRL) from the FDA. The FDA was unable to approve the NDA and asked for two more things. First, the FDA wanted additional data on at least 50 patients. Second, the FDA wanted specific changes to the applicator to prevent misuse.
  • March 8, 2018. AcelRx announced that it receives the transcript for the FDA Type A meetings, and would be resubmitting an NDA within the second quarter of 2017.
  • May 9, 2018. AcelRx resubmits an NDA for Dsubvia. The re-submission includes additional information on the Human Factors study. It also includes regulatory changes.
  • May 24, 2018. The FDA accepts the NDA resubmission for Dsuvia. A PDUFA (Prescription Drug User Fee Act) was assigned as a result. This is a huge milestone for AcelRx.
  • October 12, 2018. The Anesthetic and Analgesic Drug Products Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 10 to 3 in favor of recommending the approval of Dsuvia for treating moderate-to-severe acute pain.
  • November 2, 2018. The FDA finally approves Dsuvia for treating severe pain.

Dsuvia is expected to reach the market by the end of 2019.

The 3 Clinical Trials That Led to the Approval of Dsuvia

FDA approval of Dsuvia is mostly linked to three important clinical trials. These trials demonstrate that this prescription opioid can be used to effectively treat moderate to severe acute pain. They also demonstrate that this method of administration is not only quick but also convenient.

  • SAP 301. This clinical trial demonstrated that Dsuvia is an effective drug for treating moderate to severe pain after abdominal surgery. Those who took the drug experienced a far greater pain reduction than those who took the placebo.
  • SAP 203. This clinical trial not only looked at the efficacy of the drug but whether it caused any cognitive impairment. The study concluded that Dsuvia was not related to any drug-induced cognitive impairment. It had very few side effects in comparison to other alternatives.
  • SAP 303. This clinical trial looked at whether the drug was safe and effective among all patients. Dsuvia was administered to patients of different ages and with different renal and liver functions. The study concluded that this drug is safe for all patients. It also found that the efficacy of the drug is similar for all patients.

These clinical trials have encouraged the FDA to approve this prescription opioid. With that said, some medical researchers have come out to claim that Dsuvia is not as efficient as these studies may suggest. It may actually take about an hour for this drug to have an effect on the patient. More and more studies are looking into the efficacy of this drug. It’s important for medical professionals to fully understand what’s involved with administering this prescription painkiller. The studies in question are also being investigated thoroughly at this time.

Differing Opinions on Dsuvia

FDA approval of Dsuvia has led to the emergence of many differing opinions. While some researchers and scientists believe that Dsuvia is able to fill in a void that most prescription opioids can’t, others believe that Dsuvia will only worsen the opioid epidemic. With everything in this world, there are always pros and cons. This is the same for Dsuvia. It’s clear that the medical and scientific community are at odds over the decision to approve this drug for medical usage. Let’s explore what some specialists are saying.

Opinions FOR Dsuvia

Dsuvia is able to help a very specific group of patients who are struggling with pain. Due to this reason, many professionals in the medical community support FDA approval. They believe that this prescription drug will not be easily abused thanks to all of the regulations that are in place. These professionals have high hopes for Dsuvia. They hope that it will help patients who are struggling with moderate to severe pain but cannot receive intravenous painkillers. They hope that the fact that this drug can only be used in inpatient settings will make a difference. Those who rally for Dsuvia are often surrounded by patients who cannot benefit from most prescription opioids on the market right now.

Statement from FDA Commissioner Scott Gottlieb

FDA Commissioner Scott Gottlieb is perhaps one of the most outspoken advocates for the approval of Dsuvia. He has released a recent press announcement that clarifies why he believes Dsuvia to be a benefit to society. For one, he believes that this drug will greatly help our nation’s soldiers. There is a huge medical need that is being unmet on the battlefield. Dsuvia can help treat seriously injured military personnel in an effective and safe manner. “This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield.” Gottlieb believes that many potential risks associated with Dsuvia are mitigated due to the limitations placed on its use. For one, this drug cannot be used in outpatient settings. It can only be administered by a medical professional in an inpatient setting, like at a hospital or at a medical center. The risk of abuse and addiction is also lowered since this drug cannot be used for more than 72 hours. More importantly, Dsuvia is only prescribed to patients who cannot take any other prescription opioids.

Vince Angotti, Chief Executive of AcelRx Pharmaceuticals

Vince Angotti, Chief Executive of AcelRx Pharmaceuticals, also believes that Dsuvia will help save a lot of lives. He also believes that abuse rates for this drug will be low due to the fact that this drug will diligently adhere to FDA-approved Risk Evaluation and Mitigation Strategies.

Pamela Palmer, MD, Ph.D., Chief Medical Officer of AcelRx Pharmaceuticals

Dr. Pamela Palmer, Chief Medical Officer of AcelRx Pharmaceuticals, has also advocated for the approval of Dsuvia. This is mostly because she has seen the challenges that some patients may face with intravenous opioids. Those who are unable to access intravenous opioids may feel as if there is nothing that they can do to treat the pain. Their quality of life will decrease significantly. “As an anesthesiologist, I’ve seen the challenges that IV opioids pose to patients and providers, such as logistical delays in initiating IV lines, difficulty in accessing veins, and medication errors with injectable opioids. AcelRx was founded to develop a simple, effective, non-invasive analgesic option to enable healthcare professionals to rapidly manage their patients’ acute pain.” Dsuvia can offer the pain relief needed in an efficient and timely manner. She also approves of this drug because it will only be used in an inpatient setting and because all of the doses are pre-set. This decreases the risk of overdose and abuse. Some people are concerned that drug addicts may try to steal this drug. Palmer has retorted with the fact that only 0.7% of abused opioids are stolen from medical settings.

Opinions AGAINST Dsuvia

According to the National Institute on Drug Abuse (NIDA), opioid overdoses claimed more than 47,000 American lives in 2017. These numbers have continued to skyrocket year after year. It’s no surprise that many people are against the approval of this new drug. With rising concerns surrounding the national opioid crisis, many people feel that Dsuvia will only cause more harm than good. They’re calling the FDA to reconsider their decision and are criticizing this latest decision. Here are some opinions from professors, researchers, and qualified healthcare specialists.

Raeford Brown, MD, chair of the FDA’s Anesthetic and Analgesic Drug Products Committee

Perhaps, one of the most outspoken medical professionals who is against the FDA approving Dsuvia is Dr. Raeford Brown. On October 18, Dr. Brown wrote a public letter to the FDA outlining the dangers of approving Dsuvia. He believes that there are no safeguards that will really prevent this opioid from being abused. After all, once a decision has been made by the FDA, there is not a lot of action taken afterward to enforce the safety of the drug. There is not enough follow-up to ensure that this drug will not be abused. For example, the FDA does not have a system in place to see who is taking the drug or whether doctors are prescribing this drug in an appropriate manner. “I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market.” Dr. Brown claims that America will face a larger opioid crisis with the approval of Dsuvia. He believes that this drug should be pulled from the market and that the FDA should reconsider the approval. He also believes that a sublingual administration will be detrimental to the general public. After all, this method of administration will only make this drug more accessible to more drug users.

Dr. Andrew King, Clinical Assistant Professor and Medical Toxicology Fellowship Director at Detroit Medical Center

“Sufentanil is highly potent, small, and easily diverted because it is small and potent. It is unclear if there is a real clinical need for this drug in this formulation.” Dr. Andrew King believes that Dr. Brown’s concerns are spot on. Since sufentanil is so potent, it may have narrow therapeutic uses.  Those who do end up using this drug may end up abusing heroin.

Other Quotes from Addiction Experts in America

The medical community is heavily divided. Here are some other quotes to consider. “Allowing a much more potent drug like sufentanil to come on the market is directly contrary to our efforts to curb the opioid epidemic and the opioid overdose rates.” ~ Dr. Jon Koning, a pain management physician at Texas Health Plano “This country doesn’t need another, more easily abused form of the potent opioid fentanyl to be approved. The FDA has consistently shown an inability to safeguard our citizens from deadly prescription drugs. They are not equipped to do a post-marketing analysis of prescribing behavior, and there has been evidence that there will be little in the way of education on appropriate prescribing practices.” ~ Deni Carise, Ph.D., adjunct clinical assistant professor at the University of Pennsylvania

A Look at America’s Opioid Crisis

In 2017, the U.S. Department of Health and Human Services (HHS) declared a nationwide public health emergency. America is facing a major opioid crisis. It’s clear that this issue needs to be addressed soon. To give you a better understanding of the opioid crisis, let’s take a look at some of the statistics and facts:

  • More than 131 Americans die from a drug-related overdose every day
  • 11.4 million Americans misuse and abuse prescription opioids
  • 2.1 million Americans struggle with an opioid use disorder (OUD)
  • Over 800,000 Americans abuse heroin every year, with over 80,000 Americans trying this illicit drug every year
  • 2 million Americans misuse prescription opioids for the first time every year

In 2017, HHS invested about $900 million in opioid-specific funding. The money went towards supporting addiction treatment and recovery services and programs.

From Prescription Opioids to Heroin

It’s important to note that many medical professionals are wary of using Dsuvia because they’re afraid that it will lead to an increase in heroin abuse. Studies show that approximately 80% of all heroin users started off misusing or abusing prescription opioids. Once their prescription ran out, they had no choice but to turn to illegal avenues. Heroin is an illicit opioid that is fairly easy to find. It’s also a fairly inexpensive opioid that can quickly deliver the euphoric rush that many opioid addicts seek. Those who are addicted won’t necessarily have to jump through hoops to get heroin. They can usually find this drug from a sketchy source in the downtown of a busy city. One of the main concerns here is that patients who take Dsuvia will leave the clinic addicted to an opioid. Since they no longer have any access to prescription opioids, they may turn to heroin. Some patients may have access to prescription opioids to help them taper from Dsuvia. These patients may still become chemically and physically dependent on opioids.

Opioid Addiction Treatment

Anyone struggling with any type of opioid addiction should seek addiction treatment services immediately. There are many different options to choose from. Most programs start off with medical detox and then move onto other components. Each drug user will need a different type of addiction treatment plan. This is because each individual will react differently to various medications and addiction treatment services. Those who are seeking professional substance abuse treatment must look for a rehab facility that can offer them individually tailored treatment programs. Let’s take a look at some of the options available below.

Inpatient vs. Outpatient Opioid Rehab

Addicts who are looking to get sober are more likely to succeed if they get help from an alcohol or drug rehab facility. At the very least, those who seek professional treatment will be equipped with the recovery tools and skills needed to face an addiction head on. There are many factors to consider when choosing a drug and alcohol treatment center. For example, potential clients should consider:

  • The staff-to-client ratio. A lower ratio will generally indicate a higher level of care. Clients won’t need to fight for attention. Instead, all of their needs will be promptly met.
  • Whether the rehab facility has Joint Commission Accreditation. This indicates that the rehab center only uses approved treatment approaches.
  • The type of treatment programs and amenities that are offered. This may include the type of behavioral therapy and addiction treatment services that the rehab center can provide. Each center specializes in something different.
  • The testimonials of past clients. Figure out the quality of care that each rehab facility can provide based on what others have said. Look for treatment facilities with raving reviews.
  • The overall cost of the treatment.

Another important thing to consider is the level of care that the center can provide. Most rehab centers offer either inpatient or outpatient care. Let’s take a look at the differences below.

Inpatient Opioid Rehab

Inpatient treatment programs offer the highest level of care possible. These programs require patients to pack and move into the rehab facility for 28 to 90 days. There, patients will be under constant supervision. All of their needs will be immediately met. Inpatient programs typically start off with 1 to 2 weeks of medical detox. Once patients have completed the medical detox part of the program, they move onto behavioral therapy, counseling, independent living classes and more. Those who choose this level of care will need to take an extended leave of absence from their work or school. With that said, they can focus their attention solely on their recovery. This type of program is highly recommended to those who struggle with severe substance use disorder (SUD). It’s also highly recommended to those who are likely to experience dangerous and life-threatening withdrawal symptoms.

Outpatient Opioid Rehab

Outpatient treatment programs don’t require much commitment. Patients can decide when they would like treatment. They can go whenever they want. There are different types of outpatient care. Some of the options available include:

  • Partial Hospitalization Programs (PHPs), which involve 5 days of treatment each week.
  • Intensive Outpatient Programs (IOPs), which involve 9 hours of therapy a week.
  • Standard outpatient programs, which come with no time commitment at all.

Outpatient programs are most ideal for those who have already completed a residential inpatient program. They’re also highly recommended to those who struggle with a mild to moderate SUD. Those who abuse opioids, but aren’t addicted yet may also want to choose an outpatient program to get their bad habit under control.

Medication-Assisted Treatment for Opioid Addiction

Medical detox is an important part of any addiction treatment plan. Medication-assisted treatment (MAT) will normalize brain chemistry levels and help patients stabilize. There are many different medications used for opiate detox. Some medications treat specific symptoms. Other medications are approved by the FDA to specifically treat the neurochemical imbalances caused by an addiction to opioids. The FDA has currently approved several drugs to treat opiate withdrawals. Drugs that are mild opioids themselves are part of a detox program known as Opiate Replacement Therapy (ORT). The different types of medications that can be used during detox include:

  • Lucemyra, also known as lofexidine. This is one of the first non-opioid treatments for opioid addiction. This drug can ease withdrawal symptoms. Since it is not an opioid, it is impossible for patients to develop a secondary addiction.
  • Methadone. This is a full opioid agonist, which means that it works in the same way as heroin. It stimulates the opioid receptors to ease withdrawal symptoms. The only difference is that it is easier to wean off this medication.
  • Suboxone. This is a partial opioid agonist that contains buprenorphine and naloxone. This drug has a maximum threshold. Taking a larger dose will not result in a stronger high. Due to this reason, suboxone has a lower potential for abuse than methadone.
  • Vivitrol or naltrexone. This is an opioid antagonist, which means that it blocks opioid receptors. This medication is administered in the form of a once-a-month injection. Patients must be free of opioids and alcohol for at least 7 days before they can take this medication.

Some drug rehab centers may also use benzodiazepines as part of their medical detox program. Some benzodiazepines can ease withdrawal symptoms for a more comfortable recovery. The dose of each medication will vary based on the patient.

Behavioral Therapy and Counseling

Addiction is as much psychological as it is physical. Substance abusers looking to achieve lifelong sobriety will need to work on their psychological issues as well. They’ll also need to learn how to manage addictive behaviors and how to cope with cravings and deal with stresses in their day-to-day lives. Behavioral therapy and counseling will also help some patients learn how to stay motivated and maintain a positive mindset when dealing with addiction. Most patients will try several different types of behavioral therapies and counseling services in order to find one that works for them. There are many effective treatment modalities that support addiction recovery. Some options include:

  • Cognitive Behavioral Therapy (CBT)
  • Dialectical Behavioral Therapy (DBT)
  • Eye Movement Desensitization and Reprocessing (EMDR)
  • Family therapy
  • Group counseling
  • Motivational Enhancement Therapy (MET)
  • Motivational Interviewing
  • One-on-one counseling
  • Rational Emotive Behavioral Therapy (REBT)

Other than behavioral therapy, patients will also learn how to manage their stress with massage therapy, art therapy and more. Patients find themselves during their therapeutic modalities, and learn how to become more self-aware of their actions and thoughts.

Naloxone and Dsuvia

Currently, many government agencies and medical centers are fighting the opioid epidemic with naloxone. This is an opioid-reversing medication or an antidote that can save the lives of overdosed individuals by blocking the opioid receptors in the central nervous system (CNS). Naloxone can be considered as the first line of defense against an opioid overdose. From 1996 to 2014, community-based overdose prevention services have recorded over 26,000 opioid reversals in America thanks to naloxone. That’s a significant sum. Without this prescription medication, it’s clear that we would have lost a lot more lives to this growing epidemic. Many people are concerned whether naloxone can reverse the effects of Dsuvia. After all, this drug is more potent than fentanyl. It will have a stronger effect on the human body. Overdose victims may experience respiratory and cardiac depression and failure at a faster rate. There currently isn’t enough research in this area. With that said, some researchers claim that Dsuvia is so potent that naloxone may not work if the opioid was administered intravenously. Those who abuse this formulation will likely die, and there’s nothing that can be done about it. “It is so potent that abusers of this intravenous formulation often die when they inject the first dose.” ~ Dr. Brown, an anesthesiology professor at the University of Kentucky With that said, many researchers also argue that overdoses should not be an issue. After all, Dsuvia will only be administered in hospitals and medical centers. This prescription opioid will not be available for outpatient use. The dosage of this drug will be carefully monitored. Also, only the sublingual form will be administered. Due to this reason, there is not a lot of room for abuse.

Is Dsuvia Good or Bad for America?

The main question on everyone’s minds is whether Dsuvia will cause more harm than good for America. Will Americans be able to abuse this drug easily? Or, will those who are prescribed this drug get addicted to prescription opioids and move onto other illicit options, like heroin? If this happens, more and more Americans will need drug addiction treatment services. The truth is that it’s still too early to tell. There is not enough information out there for us to determine whether Dsuvia will contribute to America’s growing opioid crisis. While some specialists believe that this drug will kickstart another wave of addiction, others believe that it may end up saving many lives, especially on the battlefield. Many people speculate that those who use Dsuvia will easily get hooked due to its potency. These individuals are going to need to seek help from a drug rehab program. They’ll likely have a difficult time weaning off this opioid. Many people are worried that it will be easy to develop a chemical and physical dependence on this drug since it is so potent. Even more, people are worried that there are not enough barriers in place to prevent Dsuvia from being abused. After all, although the FDA requires the opioid to be regulated, the organization does not do much to follow-up with the drug. Due to all of the reasons above, there is a lot of controversy surrounding the FDA’s latest decision to approve this potent opioid. What are your opinions about Dsuvia? Let us know in the comments below!

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