Alkermes' Vivitrol Gets Speedy FDA Review

FDA will issue approval decision for Vivitrol as a treatment for opioid dependence on Oct. 12.
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Waltham, Mass. (


) --


(ALKS) - Get Report

will hear from U.S. drug regulators by Oct. 12 about an approval decision for the company's drug to treat patients addicted to opioid painkillers, the company said.

The U.S. Food and Drug Administration granted a six-month priority review to Vivitrol for the treatment of opioid dependence based on a phase III study that demonstrated Vivitrol's ability to significantly reduce opioid abuse compared to treatment with a placebo.

Alkermes has marketed Vivitrol as a treatment for alcohol dependence since 2006 with lackluster results. Vivitrol sales totaled $20.2 million in the fiscal year ended March 31, 2010. The opioid dependence treatment market is larger and more established, however, so an expanded approval for Vivitrol has the potential to boost sales significantly.

Alkermes doesn't want to give revenue guidance for Vivitrol in opioid dependence pending FDA's approval decision, but CEO Richard Pops offers as a comparable the $900 million in 2009 sales of Suboxone, another drug used to treat opioid dependence.

"There is a big unmet medical need for a drug like Vivitrol," says Pops, referring to the fact that Vivitrol is given as a convenient, once-monthly injection and that the active ingredient, naltrexone, is not a narcotic and is not addictive.

Lazard analyst Terence Flynn is more conservative, projecting a $300 million market opportunity for Vivitrol in opioid dependence.

Researchers are presenting the final data from the phase III study of Vivitrol in opioid dependence at this week's annual meeting of the American Psychiatric Association. In the study of 250 Russian opioid addicts, 90% of patients treated with Vivitrol had opioid-free urine samples after 24 weeks compared to 35% of patients treated with sham injections. The results were highly statistically significant. Thirty-six percent of Vivitrol patients were totally abstinent during the study compared to 23% of placebo patients, a result that was also statistically significant.Treatment with Vivitrol also led to more patients completing treatment and a significantly reduction in patient-measured cravings for opioids.

"The Vivitrol data were better than what we anticipated because of the consistency and breadth of the improvements in patients seen across all the endpoints of the study," said Pops.

Alkermes does not expect FDA to bring Vivitrol in front of an advisory panel given that the drug is already approved for alcohol dependence. Alkermes will be ready to launch Vivitrol into the opioid dependence market immediately if FDA approves the drug on Oct. 12, said Pops.

October is shaping up to be busy month for Alkermes. On Oct. 22, the FDA is also expected to issue an approval decision for Bydureon, the company's long-acting diabetes drug which is partnered with Amylin Pharmaceuticals and Eli Lilly.

Alkermes shares were down 4.4% to $10.30 in recent Tuesday trading.

-- Reported by Adam Feuerstein in Boston.

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