Alkermes, Inc. (ALKS)

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Alkermes Initiates Phase 3 Clinical Study of VIVITROL(R) for the Treatment of Opioid Dependence
Thursday June 26, 8:30 am ET

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alkermes, Inc. (NASDAQ: ALKS - News) today announced the initiation of a phase 3 clinical trial of VIVITROL® (naltrexone for extended-release injectable suspension) for the treatment of opioid dependence. The multi-center study is designed to assess the efficacy and safety of VIVITROL in approximately 200 patients diagnosed with opioid dependence. The clinical data from this study will form the basis of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for VIVITROL for the treatment of opioid dependence, a chronic brain disease.

"Opioid dependence is a serious disease affecting millions of people yet there are few approved medications available for these patients and no approved long-acting antagonist therapies," stated Dr. Herbert Kleber, Professor of Psychiatry, Director, Division on Substance Abuse, Columbia University. "Naltrexone, the active ingredient in VIVITROL, has been shown to effectively block the effects of opiates but patients have difficulty complying with a daily medication regimen. Therefore, I am pleased to see the development of new therapeutic options, such as VIVITROL, which could provide an important approach to long-term recovery and potentially help reduce the risk of relapse."

In addition to the use of heroin, an illegal opioid, opioid abuse and addiction includes the non-medical use of approved opioid analgesics, including prescription pain relievers, and represents a growing public health problem in the U.S. According to the 2006 U.S. National Survey on Drug Use and Health, an estimated 1.9 million people aged 12 or older were dependent on or abused pain relievers or heroin.1 In 2005, the European Monitoring Centre for Drugs and Drug Addiction estimated the prevalence of problem opioid use in Europe to be in the range of 1.3 to 1.7 million people.2 Researchers have found that the cost of prescription opioid abuse in the U.S. in 2001 was $9.2 billion.3

"The advancement of VIVITROL into phase 3 development for an indication of opioid dependence marks an important milestone for the program," stated Dr. Elliot Ehrich, Chief Medical Officer of Alkermes. "If approved, VIVITROL would be the first and only non-narcotic, non-addictive, long-acting medication for the treatment of opioid dependence."

Study Design

The phase 3 randomized, multi-center study is designed to assess the efficacy and safety of VIVITROL compared to placebo treatment in opioid dependent subjects who have been recently detoxified and abstinent from opioids for a minimum of seven days prior to treatment initiation. Approximately 200 subjects will be randomized to receive once-monthly intramuscular injections of either VIVITROL or placebo in combination with counseling for six months. The primary efficacy endpoint is the response profile based on the rate of positive urine drug test results. All participants who complete the randomized portion of the study will be eligible to continue in an open-label phase and receive VIVITROL once-monthly in combination with counseling for an additional seven months. The objective of the extension phase of the study is to assess the long-term durability of effect, health economics and quality of life outcomes with once-monthly VIVITROL injections.