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Article: Alkermes initiates clinical trial for ALKS 33, a novel oral molecule with potential benefits in addi

Alkermes, Inc. recently announced the initiation of a phase 1 study of ALKS 33, an oral opioid modulator for the potential treatment of addiction and other central nervous system (CNS) disorders. ALKS 33 is the company's first novel, small molecule drug candidate to enter the clinic. The molecule builds on Alkermes' scientific expertise in brain reward pathways as well as the company's clinical and commercial knowledge in the field of addiction. In addition, Alkermes initiated a clinical pharmacokinetic study to further explore ALKS 29, a potential oral treatment for alcohol dependence.

The phase 1 randomised, double-blind, placebo-controlled study for ALKS 33 will enrol 16 healthy volunteers and is designed to assess the pharmacokinetics, safety and tolerability of ALKS 33 following single oral administration at escalating dose levels. The company expects to report top-line results from the study in the first half of calendar 2009. Initiation of this trial is based on recent data from preclinical studies that showed ALKS 33 demonstrated statistically superior oral efficacy compared to naltrexone. The studies also suggested that ALKS 33 is not readily metabolised by the liver, a unique advantage over existing oral therapies for addiction.

"There are few medications available to help patients struggling to overcome addictions and new treatment options are desperately needed," said Elliot Ehrich, M.D., chief medical officer of Alkermes. "We believe that the addiction field will evolve in a similar way to other CNS markets, such as mental illnesses, where treatments include both oral and injectable medications. This flexible approach offers patients and doctors the option to build the most appropriate therapies into treatment programs and fit the needs of individual patients."

As part of the company's strategy, Alkermes is planning additional preclinical studies of ALKS 33 for other CNS disorders and has also initiated a phase 1 study of ALKS 29, a potential oral treatment for alcohol dependence. The open-label crossover study is designed to assess the pharmacokinetics, safety and tolerability of ALKS 29 compared to an oral control. The company expects to report top-line results from the study in the first half of calendar 2009.

The development of these two candidates further underscores the significant expertise in and commitment to the area of addiction at Alkermes. VIVITROL®, the company's first commercial product in addiction, is currently approved for the treatment of alcohol dependence in the U.S. and Russia. VIVITROL is the only once-monthly injectable medication approved for the treatment of alcohol dependence.

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