Alkermes Wins FDA Panel Nod
Alkermes (NASDAQ: ALKS), the Waltham, MA-based biotech company, received some good news today from an FDA advisory panel. The FDA’s panel of psychiatric drug experts voted 12-1 to recommend that the FDA approve Alkermes’ long-lasting naltrexone (Vivitrol) as a treatment for opioid dependence. The FDA, which usually follows the recommendations of its advisory panels, has until Oct. 12 to complete its review of the treatment. “If approved, Vivitrol would offer a new path to recovery as the first non-addictive, once-monthly medication for patients with opioid dependence,” Alkermes CEO Richard Pops said in a statement. The drug was first approved by the FDA in 2006 as a treatment for alcohol dependence. The product generated $20.2 million in sales in the most recent fiscal year, Alkermes has said.