FDA greenlights first nonopioid drug for opioid withdrawal

FDA Approves Lofexidine Hydrochloride, First Non-Opioid Treatment for Management of Opioid Withdrawal Symptoms in Adults

In a May 16 announcement, the FDA stressed that Lucemyra isn't a treatment for opioid use disorder, but rather a potential tool for managing the disorder long-term.

The non-opioid tablets can be used for up to two weeks.

For those addicted to opioids, quitting cold turkey can be a harrowing experience. Other symptoms include anxiety, agitation, depression and insomnia.

"We're developing new guidance to help accelerate the development of better treatments, including those that help manage opioid withdrawal symptoms", said FDA Commissioner Scott Gottlieb, MD. Before, people going through detox were given opioids which can be very addictive.

The safety and efficacy of Lucemyra was validated in two randomized, double-blind, placebo-controlled clinical trials of 866 adults who were physically dependent on opioids and undergoing abrupt opioid discontinuation.

Lofexidine Hydrochloride, also referred to as the brand name Lucemyra, is now FDA Approved.

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

The data showed patients treated with Lucemyra reported lower SOWS-Gossop scores vs placebo. Treatment with Lucemyra may lessen the severity of opioid withdrawal symptoms but it may not completely prevent them.

The FDA has requested 15 post-marketing studies, in both animals and humans, to support longer-term use of the drug and use in children or adolescents under 17. Total treatment may last up to 14 days. Patients abusing the drugs can suffer more severe withdrawal symptoms, and those who intend to take Vivitrol or another addiction drug need to withdraw from opioids first. There were safety signals, however, with some of the most common side effects from treatment being low blood pressure and slow heart rate. The guidelines were not well received by patients, who said the guidelines led to less doctors prescribing opioids for their pain. "The actions of norepinephrine in the autonomic nervous system are believed to play a role in numerous symptoms of opioid withdrawal", the FDA said. Additionally, an independent FDA advisory committee supported the approval at a meeting in March.

As part of a strategy to fight the crisis, the FDA said it's working to decrease opioid exposure to prevent new addictions and punish those who contribute to illicit opioid distribution. The approval for making the drug is granted to US WorldMeds LLC. The organization likewise is in charge of the wellbeing and security of our country's sustenance supply, beauty care products, dietary supplements, items that emit electronic radiation, and for directing tobacco items.

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