FDA Approves Drug for Treating Opioid Dependency
The U.S. Food and Drug Administration (FDA) announced on Tuesday its approval of the prescription drug Vivitrol for treatment of opioid dependency.
Vivitrol (Alkermes Inc.’s brand of naltrexone (XR-NTX), an opioid-blocking, extended-release injectable suspension) has already been available on the market since 2006 as a once monthly pill for treating alcohol dependency. After extensive research found the injectable version of the drug to be effective in treating patients with opioid dependency and helping prevent relapse after detoxification, the FDA formally approved the market of the drug for opioid addiction treatment as well. In comparison to placebo groups, clinical studies found patients who were administered naltrexone were significantly more likely to complete treatment for their opioid addiction and to remain abstinent following treatment.
By blocking opioid receptors in the brain, naltrexone prevents the addictive effects of such drugs as morphine, heroin, and other opioids like powerful prescription painkillers that have become an epidemic to the nation’s health. When administered as a once-monthly intramuscular injection, naltrexone helps reduce addict’s overactive reward system that is responsible for their opioid dependency, allowing patients to sustain abstinence and avoid relapse. Naltrexone is considered the first non-addictive, non-narcotic drug agent available for treating drug addiction.
Vivitrol is to be prescribed to patients after they have undergone detoxification and are no longer physically dependent on opioids. If the patient still has opioids within their system and is simultaneously administered Vivitrol, they may experience opioid withdrawal symptoms, so initial detoxification is highly important. While being treated with Vivitrol, patients will be unable to get high if they attempt opioid use. Also, the FDA warns patients not to restart opioid use while taking Vivitrol since the medication can make patients more sensitive to opioids at the time of their next scheduled injection. If patients happen to miss a scheduled dose of Vivitrol or have recently completed Vivitrol treatment, they can experience accidental overdose if they resume opioid use.
Vivitrol, although safe and effective in treating alcohol dependency, has not shown much use in the addiction treatment market or in earnings for the biotech firm Alkermes due to the drug’s retail cost and accessibility. However, with the added approval of the monthly injectable form for treating opioid dependency, the addiction medication is expected to gain more popularity in treatment use. With millions of Americans currently abusing prescription medications and the number of prescription opioid-related deaths having reached record levels, the new injectable could make a huge impact on the nation’s healthcare system by combating addiction and saving thousands of lives. Those suffering from opioid addiction can be better assured of successful treatment and continued abstinence when using Vivitrol, and can resume their normal, healthy lifestyles that benefit their families, communities, and economy. The FDA is calling the introduction of the new opioid treatment drug a great step forward in the field of addiction medicine.
The FDA advises that Vivitrol should only be administered to patients by a prescribing physician as a monthly intramuscular injection. Vivitrol should not be given to patients using any administration needles other than the ones provided with the product.
Source: Reuters, UPDATE 1-Alkermes addiction drug wins wider U.S. approval, October 12, 2010
