Alkermes to Seek FDA Approval of Anti-Addiction Drug

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Xconomy.com -- Cambridge,MA-based biotech Alkermes said this morning that its long-acting naltrexone injection (Vivitrol) was more effective in treating opioid drug dependence than placebo in a Phase III clinical trial. The 250-patient clinical trial compared urine samples of patients who took the firm’s once-per-month injection of naltrexone versus those who took placebo over the last 20 weeks of a 24-week treatment period. Alkermes (NASDAQ:ALKS) said that it plans to file an application with the FDA for approval of its drug for treating opioid dependence in the first half of 2010.
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