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First non-maintenance drug to treat opioid dependence wins FDA approval

October 13, 2010
by Gary A. Enos, Editor
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The marketing of Vivitrol will target metropolitan communities on both coasts

Patients with opioid dependence soon will have access to the first non-maintenance medication available to treat their illness, following the Food and Drug Administration’s (FDA’s) Oct. 12 approval of a new indication for the once-monthly injectable medication Vivitrol.

On the morning following the FDA announcement, executives with the manufacturer of Vivitrol emphasized in a conference call the importance of the drug’s labeling as a medication to prevent relapse to opioid dependence after detox. They said the emergence of the maintenance drugs methadone and buprenorphine (Suboxone) in the treatment of drug dependence have laid the foundation for a medical market in this area, adding that they believe Vivitrol now will prove to be an important alternative for those who see taking a maintenance medication as impractical.

“We’re not going to target people who are doing well on Suboxone," said Richard Pops, CEO of the Waltham, Mass.-based drug manufacturer Alkermes, Inc. “We’re big believers that Suboxone has helped to medicalize the field.”

Still, federal approval of an alternative to maintenance medication for opioid dependence is being seen as a major breakthrough given several existing barriers to methadone and buprenorphine use by some, including the frequent dosing and the need to receive the maintenance drug either in clinic settings or from physicians specifically authorized by the federal government to dispense the medication.

Vivitrol is the injectable formulation of the medication naltrexone. The once-monthly intramuscular injection was approved for the treatment of alcohol dependence in 2006. Unlike methadone and Suboxone, Vivitrol is a non-narcotic drug that blocks the opioid receptors that drive addiction. As such, it is seen as having no value as a street drug.

“Vivitrol makes it difficult for patients to re-establish a dependence on opioids,” Pops said.

Post-approval marketing
Pops indicated during the conference call that the medication will become available to the treatment field in a two-phase process. In the first phase, which will begin immediately, the company will target the 1,300 prescribers currently using Vivitrol to treat alcohol dependence.

The second phase will focus on reaching 600 inpatient medical-model treatment facilities and an additional 1,400 outpatient practitioners currently using other medications in opioid dependence treatment, Pops said.

Pops said the company has a sales force of 60 for marketing the new indication, and these representatives will focus largely on metropolitan areas on the East and West coasts.

Among the opioid-dependent patient groups that Alkermes considers to be ideal candidates for Vivitrol are younger patients who are new to treatment, as well as licensed professionals and members of the military whose job demands arguably make use of a maintenance medication impractical.

The monthly injections will cost $1,100 apiece, mirroring the fee structure for Vivitrol in alcohol dependence treatment. Pops said it is estimated that 70 percent of the patient base for the new indication will be privately insured, with 30 percent covered by public payers.

Pops said he sees some intrinsic differences between the alcohol and opioid treatment markets, and that could prove to make Vivitrol a more successful sell in opioid treatment than has been the case in alcohol treatment. He cited the figure of $1 billion in sales achieved by the makers of methadone and Suboxone combined, while contrasting that with an alcohol treatment model that is still dominated by counseling alone and has been less inclined to integrate medication treatments.

“If someone is motivated to remain opioid-free, this is the perfect drug for them,” Pops said.

Field energized
Swift reaction this week from addiction field leaders illustrates the perceived significance of this development. “This new option increases the pharmaceutical choices for treating opioid addiction, and may be seen as advantageous by those unwilling to consider agonist or partial agonist approaches to treatment,” said Nora D. Volkow, MD, director of the National Institute on Drug Abuse (NIDA).

Added Jerry Rhodes, president of the recovery division at nationally influential treatment chain CRC Health Group, “The FDA’s just-approved monthly drug treatment with Vivitrol could be a game changer.” A statement from CRC indicated that the company intends to develop protocols for Vivitrol therapy to treat opioid dependence, following years of productive use of the medication at its facilities in the treatment of alcohol dependence.

The FDA approval was based on results of a six-month Phase III study in which subjects received either Vivitrol or placebo after completing detox and no longer being physically dependent on opioids. The study found that 36 percent of Vivitrol-treated patients were able to stay in treatment for six months without relapsing to drug use, compared with 23 percent of the patients on placebo.

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