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Alkermes' addiction drug wins FDA nod

Alkermes' Vivitrol has received US approval as a once-monthly drug for patients with opioid dependence who have been through detoxification

The US Food and Drug Administration has approved Alkermes' Vivitrol (naltrexone for extended-release injectable suspension) as the first once-monthly drug for treatment and prevention of relapse in patients with opioid dependence who have been through detoxification.

Vivitrol has been marketed for the treatment of alcohol dependence since 2006. The non-narcotic, non-addictive medication is now also approved for use as part of a comprehensive management programme for opioid dependence that includes psychosocial support.

Vivitrol, which is administered by intramuscular injection, blocks the effects of drugs like morphine, heroin, and other opioids. In phase III clinical studies, 36 per cent of patients given Vivitrol were able to stay in addiction treatment for six months without using illicit drugs, compared with 23 per cent of the patients in the placebo group.

The approval comes after an FDA advisory committee voted overwhelmingly in September to recommend marketing clearance for the drug.

"The approval may not come as a tremendous surprise, but I hope that what will come as a surprise is the simplicity and clarity and power of the labelled indication," Alkermes chairman, president and CEO Richard F Pops said during a conference call with investors. "We think this is an extremely strong label, since opioid dependence is characterised by high rates of relapse, and prevention is a powerful new concept."

Pops noted that the competitor drugs in this market are opioid agonists, meaning that they substitute a maintenance dose of the opioid agonist as a replacement for the illicit opiate on which the patient is dependent. As a result, they are labelled as maintenance treatment for opioid dependence.

"The treatment paradigm is evolving: prevention with Vivitrol, versus maintenance," Pops said. "Vivitrol creates a new approach, as it's the only treatment approved for the prevention of relapse."

Although Vivitrol is already sold in the US, the launch for the opioid dependence indication will require new marketing strategies. Alkermes plans to begin the launch immediately by targeting the approximately 1,300 physicians who are currently prescribing the drug for alcohol to introduce them to the new indication.

Once the company's marketing materials for the new indication have been pre-cleared by the FDA, which Pops said he expects to happen in the first half of next year, Alkermes will expand its detailing efforts to a wider range of prescribers, including physicians working in about 600 in-patient facilities that have a medical model in place, as well as about 1,400 out-patient physicians who currently prescribe the majority of medications for treatment of opioid dependence.

14th October 2010

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