FDA Committee Approves Vivitrol for Opioid Dependence

FDA committee approves extended-release Vivitrol for treating opioid addiction.

Vivitrol, a combination of naltrexone for extended-release injectable suspension, received committee approval for the treatment of opioid dependence.

Alkermes, Inc, which manufactures the drug, received the approval from the FDA Pharmacologic Drugs Advisory Committee in a 12 to 1 vote.

“The Advisory Committee meeting outcome underscores the strength of the clinical data for VIVITROL and the need for new treatment options,” said Richard Pops, chief executive officer of Alkermes, in a press release. “We believe that, if approved, VIVITROL would offer a new path to recovery as the first non-addictive, once-monthly medication for patients with opioid dependence.”

The committee's recommendation will be considered by the FDA in its review of the supplemental New Drug Application (sNDA) that Alkermes has submitted for Vivitrol. The current Prescription Drug User Fee Act (PDUFA) date for the drug is Oct.12, 2010. The PDUFA date is the target date for the FDA to complete its review of the Vivitrol sNDA.

Vivitrol is a once-monthly, extended-release injectable medication for the treatment of alcohol dependence and was approved by the FDA in April 2006. The drug delivery technology in Vivitrol enables the medication to be gradually released into the body at a controlled rate over a one-month time period. The drug is administered as a gluteal intramuscular injection.

Opioid dependence is a chronic brain disease, according to the press release. It is characterized by cognitive, behavioral, and physiological symptoms in which an individual continues to use opioids despite significant harm to oneself and others. A 2008 U.S. National Survey on Drug Use and Health, estimated 1.3 million people aged 18 or older were dependent on pain relievers or heroin.

The overall cost of prescription opioid abuse in the US has been estimated at $9.6 billion, including health care, criminal justice, and workplace costs. Overall cost of heroin addiction in the U.S. has been estimated to be approximately $22 billion, including productivity losses, criminal activity, healthcare and social welfare costs.

According to Alkermes website, the new treatment paradigm includes expanding the drug’s use to treat opioid dependence.

“If approved, Vivitrol would be the first and only non-narcotic, non-addictive, long-acting medication for the treatment of opioid dependence,” the site reads.

So far, the drug has demonstrated positive preliminiary results from a phase 3 clinical trial for the treatment of opioid dependence. The announcement of results occurred in November 2009. “The six-month phase 3 study met its primary efficacy endpoint and data showed that patients treated once-monthly with VIVITROL demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo.” A supplemental New Drug Application (sNDA) for Vivitrol was submitted to the FDA in April of this year.