New Products

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

The opioid addiction market got a new player Wednesday with the FDA approval of Lucemyra, a pill that helps patients manage symptoms of withdrawal.

The drug, which has been used in the United Kingdom for more than two decades now, is made by Louisville, KY-based US WorldMeds. The specialty pharma was not granted approval to treat opioid use disorder, but instead to treat symptoms of withdrawal.

Scott Gottlieb

For those addicted to opioids, quitting cold turkey can be a harrowing experience. In as little as a few hours, patients may experience stomach cramps, muscle aches and spasms, a pounding heart, nausea, vomiting and diarrhea. Other symptoms include anxiety, agitation, depression and insomnia.

The NIH says these symptoms aren’t directly life-threatening, but they can drive the patient back to opioid use — often overdosing after experiencing withdrawal.

“We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction,” said FDA commissioner Scott Gottlieb in a statement. “The fear of experiencing withdrawal symptoms often prevents those suffering from opioid addiction from seeking help. And those who seek assistance may relapse due to continued withdrawal symptoms.”

Sharon Hertz

Lucemyra (lofexidine hydrochloride) was originally intended to be a hypertension drug. It reduces the release of norepinephrine, a hormone believed to play a key role in triggering withdrawal symptoms. In two randomized, double-blind, placebo-controlled trials, 866 adult patients demonstrated the benefits and safety of the drug. Compared to the placebo group, patients treated with Lucemyra reported a lower severity of symptoms. Plus, patients who got Lucemyra were more likely to complete the course of treatment, which can only last for up to 14 days.

The FDA is requiring 15 additional studies to further assess the drug’s safety when used in children, for longer than 14 days, and in other situations that were not tested in the earlier trials.

It will be interesting to see whether a drug like Lucemyra competes or is used in tandem with drugs like Sublocade, the injectable version of Indivior’s popular opioid use disorder drug Suboxone. Sublocade, a monthly injection of buprenorphine, contains a mild opioid to help stymie withdrawal symptoms for addicts quitting opioid use.

Sublocade is approved to treat opioid abuse disorder, but it also contains opioids itelf. Some patients — or doctors — may prefer an option like Lucemyra to ease withdrawal symptoms, as it the drug does not contain 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, director of the Division of Anesthesia, Analgesia and Addiction Products at the FDA.

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