Alkermes Inc. started a pivotal Phase III trial to study both safety and efficacy of once-monthly repeated injectable doses of Vivitrex in alcohol-dependent people.
Vivitrex is an injectable extended-release formulation of naltrexone, an FDA-approved drug used to treat alcohol dependence. Naltrexone is sold in an oral dosage form.
Alkermes, of Cambridge, Mass., will enroll 400 patients in the double-blind, placebo-controlled study that is planned for 25 U.S. sites. An extension study to obtain long-term data will commence following the initial six-month treatment period.
“The ultimate goal of our clinical development program is to provide patients, their families and caregivers with an effective alternative to daily naltrexone,” Richard Pops, CEO of Alkermes, said in a prepared statement.
Company officials could not be reached for comment.
The Phase III trial comes behind completion of a multidose, multicenter safety and pharmacokinetic clinical assessment of Vivitrex in alcohol-dependent volunteers conducted in the second half of last year.
Preliminary data from the Phase II study showed that after four treatment cycles, on average, patients treated with Vivitrex plus psychosocial therapy (n=25) experienced a 50 percent reduction in heavy drinking days when compared to patients treated with placebo injections with therapy (n=5).
While conducting the Phase III alcohol study, Alkermes will run a similar study to test safety and the pharmacokinetics of a range of doses in opiate users.
Vivitrex is based on Alkermes’ Medisorb injectable extended-release drug delivery technology and is designed for once-monthly dosing. Vivitrex is designed to work by enhancing patient compliance by removing the need for daily dosing and providing therapeutic drug levels over a month.
The National Institute on Alcohol Abuse and Alcoholism, of the National Institutes of Health, helped fund the Vivitrex studies.
Alkermes recently agreed to purchase privately held Liberty Corner, N.J.-based Reliant Pharmaceuticals LLC in a stock deal worth about $934 million. The merger unites Reliant’s three marketed product brands, its product pipeline, U.S. sales and marketing infrastructure and its management team with Alkermes’ drug formulation and development capabilities, its pipeline and its manufacturing capabilities. (See BioWorld Today, March 22, 2002.)