FDA clears new tool in fight against opioid epidemic

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

US WorldMeds explained that Lucemyra "suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal".

For those addicted to opioids, quitting cold turkey can be a harrowing experience.

Opioid withdrawal includes symptoms - such as anxiety, agitation, sleep problems, muscle aches, runny nose, sweating, nausea, vomiting, diarrhea and drug craving - that occur after stopping or reducing the use of opioids in anyone with physical dependence on opioids.

Recommended dosing for lofexidine is three 0.18 mg tablets taken orally four times daily, when patients are experiencing peak withdrawal symptoms (generally 5 to 7 days following last use of opioids, the company said in a news release).

"We know that the physical symptoms of opioid withdrawal can be one of the biggest barriers for patients seeking help and ultimately overcoming addiction", FDA Commissioner Scott Gottlieb said in a news release. Lucemyra was approved to treat withdrawal symptoms for up to two weeks.

Gottlieb also said the FDA will be developing guidance documents for the most efficient path for developing drugs that can be used to treat various types of pain.

The FDA's approval of Lucemyra is supported by two randomized, double-blind, placebo-controlled clinical trials, an open-label study and clinical pharmacology studies with concomitant administration of either methadone, buprenorphine or naltrexone.

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

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.

In patients utilizing opioid analgesics fittingly as endorsed, opioid withdrawal is regularly overseen by a moderate decrease of the prescription, which is planned to dodge or reduce the impacts of withdrawal while enabling the body to adjust to not having the opioid. Lucemyra's side effects could include hypotension, bradycardia, sleepiness, and dizziness.

"There are many people who are physically dependent, meaning if you stop it, you're going to get withdrawal symptoms", but those people may not be to the point of negative social behavior, such as stealing things or ruining relationships, said Dr. Mark Pirner, senior medical director of Clinical Research and Medical Affairs for US WorldMeds. Safety and efficacy in patients younger than 17 has not been established, the agency noted.

The FDA allowed this application Priority Review and Fast Track assignments, and an autonomous FDA warning board bolstered the endorsement of Lucemyra at a gathering held March.

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