Alkermes initiates Phase I study of addiction drug

The Phase I randomized, double-blind, placebo-controlled study for ALKS 33 will enroll 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 metabolized by the liver, a unique advantage over existing oral therapies for addiction.

As part of the company’s strategy, Alkermes is planning additional preclinical studies of ALKS 33 for other central nervous system disorders and has also initiated a Phase I 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.

David Broecker, president and CEO of Alkermes, said: The progress of these two candidates clearly demonstrates our commitment to building a commercial enterprise with promising prospects for growth. The combination of our strong financial health, the success of two commercial products and our proven science puts Alkermes in a unique position to create new proprietary product opportunities that have the potential to help address the needs of a broad range of patients.