Long-acting alcoholism drug wins support

U.S. health officials have granted conditional approval for Alkermes Inc.'s once-a-month drug to treat alcoholism in adults, when used along with counseling, the company said on Wednesday.

The drug, called Vivitrol, is an injectable form of naltrexone administered monthly to help ward off a craving for alcohol and should be available in the second quarter of 2006, according to the company.

Alkermes shares rose as much as 7 percent, in after-hours trading following the news.

Before final approval to sell the drug, formally called Vivitrex, Alkermes said it must still meet several conditions set by the Food and Drug Administration, including providing the agency additional preclinical data.

Alkermes officials told Reuters earlier this month they plan to target the more than two million persons seeking treatment each year, but could not disclose estimated sales figures.

"At launch, our focus is on those patients who are motivated to stop" drinking, Alkermes Chief Executive Officer Richard Pops told Reuters in an interview earlier this month. "There (are) enough patients in that 2.3 million people to have an enormous medical impact."

Nearly 18 million American adults are alcohol dependent or abuse alcohol, according to the National Institute on Alcohol Abuse and Alcoholism.

CIBC World Market analysts have said Vivitrex could reach peak sales of more than $500 million.

"We believe Vivitrex could become the gold standard for treatment of alcohol dependence, particularly for patients with compliance issues," they wrote in a November research note.

Naltrexone is already available in pill form to help treat alcoholics and some drug addicts, but experts have said it can be easy for addicts to slip up and miss taking their pills. It is sold generically and under the brand name Revia by Barr Pharmaceuticals Inc. unit Duramed Pharmaceuticals Inc.

Alkermes' Pops said having to take a drug once-a-month should make it easier for patients to improve.

"The problem that alcohol-dependent patients have is with compliance ... each day you have to make a decision to take your drug or drink," Pops told Reuters. Vivitrex "removes the need for daily decision making."

Reuters