FDA Panel votes Lofexidine for approval for Opioid Withdrawal

Lofexidine is going to become the first non-opioid medication approved to treat opioid withdrawal and the first drug approved to help patients successfully terminate their opioid discontinuation treatment after an FDA advisory committee voted it for approval.The Advisory Committee's discussions were based on company's New Drug Application (NDA) for Lofexidine (LUCEMYRA), which is currently under priority review by the FDA.Lofexidine suppresses the neurochemical surge that produces the acute and painful symptoms of opioid withdrawal. In clinical trials compared to placebo, participants treated with LUCEMYRA experienced less severe withdrawal symptoms and were more likely to complete a seven-day opioid discontinuation treatment. Opioid withdrawal symptoms may include feeling sick, stomach cramps, muscle spasms/twitching, feeling of coldness, heart pounding, muscular tension, aches/pains, yawning, runny eyes, insomnia/problems sleeping.

The NDA includes data from two randomized, double-blind, placebo-controlled clinical trials and several supporting studies that examined the safety and efficacy of Lofexidine (LUCEMYRA).The committee reviewed the data and then voted 11-1 to support lofexidine's secondary indication, to help patients complete the process of withdrawal from physical opioid dependence.Several committee members insisted, however, that lofexidine's recommended dosage be limited to 2.4 mg daily -- as opposed to the 3.2 mg dose suggested by US WorldMeds -- and called for post-marketing studies.

"Today's favorable recommendation brings us one step closer to providing evidence-based medication, and hope for recovery, to people who want to discontinue opioid use and are struggling with the agonizing symptoms of opioid withdrawal, one of the most powerful factors driving opioid dependence and addictive behaviors," said Mark Pirner, M.D., Ph.D., senior medical director. "We look forward to working closely with the FDA to bring this much-needed medication to people in the United States."

The FDA will consider the Advisory Committee's non-binding recommendation in its review of the NDA for LUCEMYRA. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date in the second quarter of 2018.