FDA Committee Recommends Naltrexone for Opioid Addiction Treatment

FDA Committee Recommends Naltrexone for Opioid Addiction Treatment

Currently, the prescription medication naltrexone is commercially available for the treatment of alcohol dependence under the brand name Vivitrol by Alkermes since it gained approval from the U.S. Food and Drug Administration (FDA) in 2006. After considering Alkermes’ supplemental New Drug Application (sNDA), submitted earlier this year, that showed extensive evidence of the alcohol-dependency treatment medication’s positive effects on opioid addiction, the FDA’s Psychopharmacologic Drugs Advisory Committee has now recommended the commercial use of naltrexone for the treatment of opioid dependency. The opioid-blocking, extended-release injectable suspension may become the first non-addictive, non-narcotic drug agent available in a monthly prescription come October.

After meeting on Thursday, September 16, the FDA’s Advisory Committee agreed with Alkerme’s sNDA and its research that was first introduced at the 2010 American Psychiatric Association (APA) Annual Meeting in May, where four clinical studies demonstrated naltrexone’s ability to suppress both alcohol and opioid cravings and withdrawals. The FDA will consider the recommendation of the Advisory Committee and formally announce its final decision on October 12, 2010. The FDA is not obligated to agree with the recommendations of its Advisory Committee—a panel of outside experts—although the U.S. administration historically tends to follow suit.

The Advisory Committee voted 12 to 1 in favor of naltrexone’s use in the treatment of opioid dependency and found the sNDA to be particularly favorable since the clinical trials of the drug showed no apparent serious side effects. Although the clinical trials did show positive results among sample populations of alcoholics or opioid addicts compared to placebo-administered control groups, the Advisory Committee was concerned about the efficacy of a single research study that was held outside the U.S.

“Efficacy and Safety of Extended-Release Injectable Naltrexone (XR-NTX) for the Treatment of Opioid Dependence,” conducted by lead investigator Dr. Evgeny Krupitsky of St. Petersburg Regional Center of Addictions in Russia found that naltrexone injections successfully reduced drug cravings among opioid-dependent individuals. In a 24-week investigation involving 250 opioid-dependent participants who had opioid addiction for 10 years, the group administered naltrexone injections showed significant reductions in their cravings, physiologic dependence, and self-reported opioid use, and had better retention compared to the placebo group. These participants were more capable of suppressing their cravings, preventing relapse and sustaining abstinence.

Due to the disruption of normal neurotransmission in the brain’s reward system caused by opioid use, opioid abusers become physiologically vulnerable to their cravings and often relapse even after undergoing treatment. The experts from the clinical trials as well as the FDA Advisory Committee caution that naltrexone may not be an absolute cure-all to alcoholism or opiate addiction, but the benefits of this new injectable does give the field of addiction medicine more options when it comes to treating opioid addiction, which as of yet has no other pharmacological form of treatment.

Source: MedScape Today, Emma Hitt, FDA Panel Recommends Naltrexone Extended-Release Injectable Suspension for Opioid Addiction, September 17, 2010

Find relief in recovery. Life gets better with addiction treatment.

Call our experts today.