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UPDATE 1-Alkermes says drug meets main goal of late-stage trial

Mon Nov 16, 2009 9:33am EST

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* Says opioid dependence drug met all its secondary goals

Stocks  |  Regulatory News  |  Healthcare

* Sees to file sNDA with the FDA in H1, 2010

* Shares up 10 pct in pre-market trade

Nov 16 (Reuters) - Alkermes Inc (ALKS.O) said its alcohol dependence drug Vivitrol met the main goal of a late-stage study that was testing it for the treatment of opioid dependence, sending its shares up as much as 10 percent in pre-market trade.

The company said data from the six-month study showed that patients treated once a month with Vivitrol, also known as XR-NTX, demonstrated statistically significant higher rates of clean, opioid-free urine screens, compared to patients treated with a dummy drug.

The study also met all its secondary goals, the company said.

Alkermes said it plans to file a supplemental new drug application for the additional indication with the U.S. Food and Drug Administration in the first half of calendar 2010.

XR-NTX, marketed by Alkermes as Vivitrol, is an extended-release version of the generic anti-addiction drug naltrexone, which is used to treat alcohol dependence.

Shares of the company rose 10 percent to $8.74 Monday in pre-market trade. They closed at $7.91 Friday on Nasdaq. (Reporting by Anuradha Ramanathan in Bangalore; Editing by Jarshad Kakkrakandy)



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