Alkermes is celebrating the news that advisors to the US regulator have backed the firm's alcoholism drug Vivitrol as a treatment for addiction to opioid drugs.
The US Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee has voted 12 to 1 that Vivitrol (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence. Earlier in the week, agency staffers said that an efficacy study carried out by Alkermes "provides convincing evidence that Vivitrol prevents relapse to opioid use in recently-detoxified opioid-dependent patients".
Some reviewers had been concerned that the data was based on one small study in Russia that was performed in a patient population with "demographic, cultural, and societal differences from the target population." Despite this, however, the panel believes the results are relevant to the USA.
Alkermes chief executive Richard Pops said the advisory committee's vote "underscores the strength of the clinical data for Vivitrol and the need for new treatment options". If approved, the drug would offer "a new path to recovery as the first non-addictive, once-monthly medication for patients with opioid dependence," he added.
The FDA's Prescription Drug User Fee Act date for Vivitrol is October 12.