FDA approves first non-opioid to treat withdrawal symptoms in adults

FDA approves first non-opioid to treat withdrawal symptoms in adults

US WorldMeds announced Wednesday that the U.S. Food and Drug Administration had approved the drug, Lucemyra, to help manage the symptoms of opioid withdrawal.

"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. Some patients - or doctors - may prefer an option like Lucemyra to ease withdrawal symptoms, as it the drug does not contain opioids. It is not an addiction treatment but can be part of a longer-term plan.

Now, the FDA is asking for input from chronic pain patients again to learn more about the "impacts of chronic pain, [patient] views on treatment approaches for chronic pain, and the challenges or barriers they face accessing treatments".

The FDA says that Lucemyra decreases the release of norepinephrine, a chemical that mobilizes the body for action.

Lucemyra is an oral, specific alpha 2-adrenergic receptor agonist that decreases the arrival of norepinephrine.

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The treatment had fast-track designation and was reviewed under the FDA's priority review process. Scientists believe that this chemical greatly attributes to the majority of opioid withdrawal symptoms. SOWS-Gossop scores were brought down for patients treated with Lucemyra contrasted with fake treatment, and more patients finished the treatment time of the investigations in the Lucemyra amass contrasted with fake treatment.

Side effects of the treatment included low blood pressure, dizziness, sleepiness, slow heart rate, and a few cases of syncope (fainting). Lucemyra can also effect the heart's electrical activity, which can increase risk of abnormal heart rhythms. The agency added that it's requiring 15 additional studies in both people and animals to evaluate factors such as longer-term use and the drug's effects on the liver. Safety and efficacy in patients younger than 17 has not been established, the agency noted. 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.

The drug, called Lucemyra (lofexidine hydrochloride), will also help adults who rely on opioids for pain relief. 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.

Manufacturer US WorldMeds said it will market the drug as soon as this summer, under the trade name Lucemyra.

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