FDA approves Vivitrol Drugs to treat Opioid Dependence

Posted by on Oct 13, 2010 | Leave a Comment

Alkermes Inc’s drug Vivitrol is approved as a monthly injection by the U.S. Food and Drug Administration to treat those hooked on powerful opioid painkillers. For the treatment of opioid dependence Vivitrol is the first and only non-narcotic, non-addictive, once monthly medication. In 2006, Vivitrol was approved for the treatment of alcohol dependence by the FDA.

Vivitrol Drugs

Vivitrol (naltrexone) is a special narcotic blocker drug which reduces the effects of other narcotic medicines and alcohol. When patients start taking Vivitrol they must not have any opioids in their system otherwise, they may experience withdrawal symptoms from the opioids. If the patients miss a dose or after treatment with Vivitrol has ended they can accidentally overdose when they restart opioid use. Side effects of Vivitrol are nausea, tiredness, headache, dizziness, vomiting, decreased appetite, painful joints, and muscle cramps.

Other serious side effects included reactions at the site of the injection, which can be severe and may need surgical intervention, liver damage, allergic reactions like hives, rashes, swelling of the face, pneumonia, depressed mood, suicide, suicidal thoughts, and suicidal behavior. Alkermes CEO Richard Pops said, “Opioid dependence is a growing disease and we believe that Vivitrol offers physicians and their patients a whole new approach, as the only long-acting, non-addictive treatment for opioid dependence”. He added, “We look forward to helping to improve the lives of patients with this chronic and debilitating condition.”

If you are allergic to naltrexone or having an addiction to narcotics, a history of alcohol or narcotic drug use within the past 7-10 days, or drug/alcohol withdrawal symptoms do not receive Vivitrol. Tell your doctor before receiving Vivitrol if you are allergic to any drugs or if you having kidney disease, liver disease, or a bleeding disorder like hemophilia. You may need a dose adjustment or special tests to safely receive Vivitrol if you have any of these conditions. Also tell your doctor if you are pregnant or plan to become pregnant during treatment and don’t use this medication without telling your doctor if you are breast-feeding a baby.

Comparing Vivitrol treatment to placebo treatment in patients who had completed detoxification and who were no longer physically dependent on opioids, the safety and efficacy of Vivitrol were studied for six months. Patients treated with Vivitrol were expected to stay in treatment and to avoid using illicit drugs. Compared with 23 percent in the placebo group thirty-six percent of the Vivitrol-treated patients were able to stay in treatment for the full six months without using drugs.

As an intramuscular injection, Vivitrol should be administered only by a physician using special administration needles that are provided with the product. Vivitrol should not be injected using any other needle and the suggested dosing regimen is once a month.

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