CAMBRIDGE, Mass., April 13 - The FDA has approved a monthly injectable formulation of Vivitrol (naltrexone for extended-release) for treatment of alcohol-dependent patients, the drug marketers, Alkermes and Cephalon, announced today.
The drug, intended for use by outpatients who are not actively drinking, should be used in combination with psychosocial support, the announcement said.
The companies said they will market the drug in 380 mg IM doses and expect the product to be available by June.
"Vivitrol is the first once-a-month medication for alcohol dependence that ensures patients get the benefit of medication over the entire month," said Richard Rosenthal, M.D., chairman, of psychiatry at St. Luke's-Roosevelt Hospital Center in New York, in the companies' statement.
In a six-month phase III trial, patients treated with Vivitrol (380 mg) and psychosocial support demonstrated a reduction in days of heavy drinking compared with patients treated with placebo and psychosocial support.
In a subset of patients who were abstinent for a week before starting Vivitrol treatment, the drug was associated with continued abstinence in a significant number of patients (without relapse). Moreover, patients who were abstinent before receiving the initial injection of Vivitrol had a greater reduction in drinking days and heavy-drinking days.
Although Vivitrol was generally well tolerated, with the most common side effects being nausea, vomiting, headache, fatigue, and injection site rejections, high doses of naltrexone have been reported to cause hepatocellular injury.
The drug was contraindicated in patients with acute hepatitis or liver failure, and its "use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects." But the company said that at recommended doses Vivitrol does not appear to be hepatoxic.
"Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis," the companies said.
Vivitrol is contraindicated in patients receiving opioid analgesics. Likewise, it is contraindicated in opioid-dependent patients and patients undergoing opioid withdrawal.