The Food and Drug Administration (FDA) has approved Lucemyra (lofexidine HCl; US WorldMeds) for the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.
Lucemyra, a selective alpha 2-adrenergic receptor agonist, works by reducing the release of norepinephrine and decreasing sympathetic tone; the actions of norepinephrine in the autonomic nervous system are believed to play a role in many of the symptoms of opioid withdrawal. Treatment with Lucemyra may lessen the severity of opioid withdrawal symptoms but it may not completely prevent them. It also does not stop patients from craving opioids.
“Today’s approval represents the first FDA-approved non-opioid treatment for the management of opioid withdrawal symptoms and provides a new option that allows providers to work with patients to select the treatment best suited to an individual’s needs,” said Sharon Hertz, MD, director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research.
The approval of Lucemyra was based on 2 randomized, double-blind, placebo-controlled clinical trials (N=866) of adults with opioid dependence who were physically dependent on opioids and undergoing abrupt opioid cessation. Patients’ symptoms were evaluated according to the Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop), which included feeling sick, stomach cramps, muscle spasms/twitching, feeling of coldness, heart pounding, muscular tension, aches and pains, yawning, runny eyes and insomnia/problems sleeping.
The data showed patients treated with Lucemyra reported lower SOWS-Gossop scores vs placebo. More patients in the Lucemyra group completed the treatment period of the studies vs patients in the placebo group. Hypotension, bradycardia, somnolence, sedation, and dizziness were the most common adverse effects reported.
The safety and efficacy of Lucemyra have not been established in pediatric patients <17 years of age. The FDA is requiring that US WorldMeds conduct 15 post-marketing studies to evaluate longer-term use of the drug as well as use in children. Specifically, the studies will investigate the safety of Lucemyra in situations where use may last beyond the 14-day recommended treatment period, as well as what the effects may be on blood pressure after the treatment is discontinued. Other clinical studies will include newborns with neonatal opioid withdrawal and pediatric patients of different age groups who have opioid withdrawal related to stopping medically-prescribed opioids.
“Lucemyra presents an important new tool to help people make it successfully through withdrawal, which is very often critical for linking to ongoing continuing care and next steps in treatment for opioid dependence or addiction,” said Marc Fishman, MD, medical director, Maryland Treatment Centers and assistant professor, Johns Hopkins University School of Medicine.
Lucemyra will be available as 0.18mg strength tablets in 36- and 96-count bottles.
For more information visit USWorldMeds.com.