Vivitrol Approved by FDA for Opioid Dependency Treatment
The U.S. Food and Drug Administration initially approved Vivitrol for use in the treatment of alcohol dependency in 2006. As of yesterday, Vivitrol is now also approved to treat and prevent relapse for opioid dependent patients.
Opioids are commonly prescribed because of their effective analgesic, or pain-relieving, properties. Prescription medications included in the opioid class include morphine, codeine, and oxycodone (e.g., OxyContin, Percodan, Percocet). Heroin is a non-prescription opioid.
Vivitrol is an extended-release formulation of naltrexone administered by intramuscular injection once a month. Naltrexone works to block opioid receptors in the brain. It blocks the effects of drugs like morphine, heroin, and other opioids.
Opioid dependent patients must undergo detoxification treatment first. There must not be any opioids in their system when Vivitrol treatment is begun. If there is, the patient may experience withdrawal symptoms from the opioids.
Vivitrol is administered as an intramuscular injection, using special administration needles that are provided with the product, on a once a month regimen as part of the opioid addiction treatment.
The safety and efficacy of Vivitrol in opioid dependency were studied for six months, comparing Vivitrol treatment to placebo treatment in patients who had completed detoxification and who were no longer physically dependent on opioids. Patients treated with Vivitrol were more likely to stay in treatment and to refrain from using illicit drugs. Of the Vivitrol-treated patients 36% were able to stay in treatment for the full six months without using drugs, compared with 23% in the placebo group.
Patients who are given Vivitrol may be more sensitive to opioids at the time their next scheduled dose is due. This sensitivity can make patients more susceptible to an accidental overdose if they restart opioid use upon missing a dose of Vivitrol or after treatment with Vivitrol has ended.
Side effects experienced by those using Vivitrol included 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 require surgical intervention, liver damage, allergic reactions such as hives, rashes, swelling of the face, pneumonia, depressed mood, suicide, suicidal thoughts, and suicidal behavior.
Vivitrol is manufactured by Alkermes, Inc.