FDA OKs first non-opioid treatment for opioid withdrawal

Modesto Morganelli
Mag 17, 2018

The U.S. Food and Drug Administration expedited approval of Lucemyra (luc-eh-MEER'-eh) to help combat the U.S. opioid epidemic.

Patients usually manage withdrawal symptoms by switching the opioid with another medication, or by using therapy.

"A better understanding of opioid withdrawal represents an opportunity in the prevention, treatment and recovery process for physical opioid dependence and opioid use disorder", co-author, Mark Pirner, MD, PhD, Senior Medical Director, Clinical Research and Medical Affairs, US WorldMeds, previously told MD Magazine.

Those symptoms include anxiety, muscle aches, sweating, vomiting and a craving for drugs.

"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", said FDA Commissioner Scott Gottlieb, M.D. The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. These symptoms of opioid withdrawal occur both in patients who have been using opioids appropriately as prescribed and in patients with OUD.

Withdrawal symptoms from opioids are often very hard to manage, but the approval of a new treatment could change all of that for patients.

SOWS-Gossop scores were lower for patients treated with Lucemyra versus placebo and more patients in the Lucemyra group completed the treatment period.

Lucemyra is an oral, selective alpha 2-adrenergic receptor agonist that reduces the release of norepinephrine.

The FDA is requiring the completion of 15 postmarketing animal and human studies; and additional animal safety studies will be required to support longer-term use and use in children.

Clinical studies will be required to evaluate the safety in situations where use could be expected to exceed the maximum 14-day treatment period for which Lucemyra is now approved; to gather additional safety data on the effects of lofexidine on the liver; and to further characterize the effects on blood pressure after treatment is stopped. Additionally, an independent FDA advisory committee supported the approval at a meeting in March.

Opioids were involved in more than 42,000 overdose deaths in 2016, the a year ago for which data was available, according to the U.S. Centers for Disease Control and Prevention.

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