FDA Gives First Approval To Non-Opioid Treatment For Withdrawal

FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults

The FDA approved the first non-opioid drug, lofexidine hydrochloride (Lucemyra), to help treat symptoms of opioid withdrawal in adults.

FDA Commissioner Scott Gottlieb commented on the approval, saying, "as part of our commitment to support patients struggling with addiction, we're dedicated to encouraging innovative approaches to help mitigate the physiological challenges presented when patients discontinue opioids". Patients can experience any combination of these symptoms after ceasing opioid use.

Opioid withdrawal incorporates indications for example - uneasiness, unsettling, rest issues, muscle hurts, runny nose, sweating, sickness, spewing, loose bowels and medication wanting - that happens in the wake of ceasing or lessening the utilization of opioids in anybody with physical reliance on opioids.

Gottlieb said the FDA wants to "strike the right balance" between making policies that give patients who need opioids the proper accessibility and preventing opioid exposures that lead to new addictions. Treatment may continue for up to 14 days and should be discontinued gradually over 2-4 days. This hormone is believed to play a role in symptoms of opioid withdrawal, the FDA said. This study also said that misuse (but not addiction) of opioids among chronic pain patients can be between 21 to 29 percent. Lucemyra impacts the heart's electrical action, which can expand the danger of unusual heart rhythms. When Lucemyra is stopped, patients can experience a marked increase in blood pressure. "I applaud the work of the FDA as well as the National Institute on Drug Abuse, which supported clinical studies of the treatment, in prioritizing efforts to prevent and treat opioid addiction". The safety and efficacy of Lucemyra have not been established in children or adolescents less than 17 years of age.

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The FDA is requiring 15 postmarketing studies, including both animal and human studies. Studies in pediatric patients will include studies of newborns with neonatal opioid withdrawal and studies of different age groups of children who have opioid withdrawal related to stopping medically-prescribed opioid drugs.

Human studies are needed to find out how safe lofexidine is if it's used for longer than the maximum 14-day treatment period, to get more data on how safe it is for the liver, and to further study its effects on blood pressure after it is stopped. In short, having sound, evidence-based information to inform prescribing can help ensure that patients aren't over prescribed these drugs; while at the same time also making sure that patients with appropriate needs for short and, in some cases, longer-term use of these medicines are not denied access to necessary treatments.

The FDA granted the approval of Lucemyra to US WorldMeds LLC.

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