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`FDA Approves Injectable Drug to Treat Opioid-Dependent Patients
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`FDA Approves Injectable Drug to
`Treat Opioid-Dependent Patients
`
`NEWS PROVIDED BY
`U.S. Food and Drug Administration
`
`Oct 12, 2010, 06:54 ET
`
`SILVER SPRING, Md., Oct. 12 /PRNewswire-USNewswire/ -- The U.S. Food and Drug
`Administration today approved Vivitrol to treat and prevent relapse after patients with opioid
`dependence have undergone detoxi(cid:126)cation treatment.
`
`(Logo: (cid:197)http://photos.prnewswire.com/prnh/20090824/FDALOGO)
`
`(Logo: (cid:197)http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)
`
`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. It was approved to treat alcohol
`dependence in 2006.
`
`"Addiction is a serious problem in this country, and can have devastating effects on individuals
`who are drug-dependent, and on their family members and society," said Janet Woodcock,
`M.D., director of FDA's Center for Drug Evaluation and Research. "This drug approval represents
`a signi(cid:126)cant advancement in addiction treatment."
`
`https://www.prnewswire.com/news-releas
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`Page 1 of 3
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`ALKERMES EXHIBIT 2037
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
`
`

`

`The safety and ef(cid:126)cacy of Vivitrol were studied for six months, comparing Vivitrol treatment to
`1/8/2019
`FDA Approves Injectable Drug to Treat Opioid-Dependent Patients
`placebo treatment in patients who had completed detoxi(cid:126)cation 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. Thirty-six percent of the Vivitrol-treated
`patients were able to stay in treatment for the full six months without using drugs, compared
`with 23 percent in the placebo group.
`
`Patients must not have any opioids in their system when they start taking Vivitrol; otherwise,
`they may experience withdrawal symptoms from the opioids. Also, patients may be more
`sensitive to opioids while taking Vivitrol at the time their next scheduled dose is due. If they
`miss a dose or after treatment with Vivitrol has ended, patients can accidentally overdose if
`they restart opioid use.
`
`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 should be administered only by a physician as an intramuscular injection, using special
`administration needles that are provided with the product. Vivitrol should not be injected
`using any other needle. The recommended dosing regimen is once a month.
`
`Consumers and health care professionals are encouraged to report adverse events to the FDA's
`MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.
`
`Vivitrol is manufactured by Alkermes, Inc.
`
`Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
`
`Consumer Inquiries: 888-INFO-FDA
`
`SOURCE U.S. Food and Drug Administration
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