Specialty pharma company US WorldMeds said today that an FDA committee voted 11-1 to recommend approval for lofexidine, a selective alpha 2-adrenergic receptor agonist designed to mitigate the symptoms of opioid withdrawal.
The oral drug, which US WorldMeds intends to market under the name Lucemyra, reduces the release of norepinephrine in a person’s brain and suppresses the symptoms of opioid withdrawal. Patients treated with Lucemyra in clinical trials experienced more tolerable withdrawal symptoms and were more likely to finish a seven-day opioid discontinuation program compared to patients taking a placebo, according to US WorldMeds.
If the drug snags FDA approval, it will be the first non-opioid medicine indicated to treat the symptoms of opioid withdrawal, the company touted.
“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,” Dr. Mark Pirner, senior medical director, said in prepared remarks.
The FDA is slated to make a decision about Lucemyra in the second quarter of this year.
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.