US FDA approves Alkermes' Vivitrol to treat opioid-dependent patients and orphan status for PharmaLink's Nefecon

13 October 2010

The US Food and Drug Administration has approved drugmaker Alkermes’ (Nasdaq: ALKS) alcohol dependence drug Vivitrol (naltrexone) for the treatment and prevention of relapse after patients with opioid dependence have undergone detoxification treatment.

Vivitrol is an extended-release formulation of naltrexone administered by intramuscular injection once a month. Naltrexone works to block opioid receptors in the brain. It blocks the effects of drugs like morphine, heroin, and other opioids. It was approved to treat alcohol dependence in 2006.

“Addiction is a serious problem in this country, and can have devastating effects on individuals who are drug-dependent, and on their family members and society,” said Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, adding: “This drug approval represents a significant advancement in addiction treatment."

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