Last week the Food and Drug Administration (FDA) approved the first non-opioid drug to help patients manage severe opioid withdrawal syndrome. The move marks a significant step forward in helping patients overcome the symptoms that so often lead to relapse. In the past, only drugs like Suboxone®, Vivitrol® and methadone have been available to manage long-term withdrawal. FDA Commissioner Scott Gottlieb says approval of Lucemyra is part of the agency’s commitment to encouraging innovative approaches to mitigating the physiological challenges that occur when patients discontinue opioid-based maintenance drugs. Lucemyra was approved on May 16 and will distributed by WorldMeds, LLC.
Dosage and Side Effects
It’s important to remember the Lucemyra is approved only for long-term opioid withdrawal management and is not a treatment for opioid use disorder. The drug is said to be effective in the treatment of side effects such as vomiting, diarrhea, muscle pain and agitation. It may not completely prevent symptoms and is only approved for up to 14 days. Some of the potential side effects include low blood pressure, slow heart rate, sleep disorder, fainting and irregular heart rhythms. As of now, the drug is only approved for adults. The FDA is requiring addiction scientific exploration to determine the drug’s safety and efficacy in younger patients.
What Does This Mean for the Future?
In two studies of 866 adults, those given Lucemyra reported less severe withdrawal symptoms when they abruptly stopped taking opioids, compared to those who were given placebos. Very often, physical and psychological opioid withdrawal symptoms can prevent patients from achieving lasting recovery even after they have the benefit of established maintenance medications. The use of effective non-opioid drugs may be a safer alternative in the long-term treatment of these symptoms.
Two-thirds of drug overdose deaths in 2016 involved opioids, mostly fentanyl, heroin and prescription painkillers. With relapse rates so high, the development of safer, sensible and proactive measures to addressing long-term withdrawal may increase long-term abstinence and improve treatment outcomes.