Alkermes alcoholism drug 'approvable'

CAMBRIDGE, Mass., Dec. 29 (UPI) -- Alkermes and Cephalon said Thursday they got an approvable letter for Vivitrol to treat alcoholism.

The companies said that the Food and Drug Administration issued the letter for the new treatment to be used in combination with a program that includes psychosocial support.

The firms noted that the FDA's final clearance is conditioned on minor issues, including finalizing the drug's labeling and fulfilling the agency's request for preclinical pharmacokinetic data.

The injectable drug is intended for administration once a month to treat alcohol dependence.

The new drug application for Vivitrol -- originally named Vivitrex -- was filed with the FDA in March.

Alkermes and Cephalon said they anticipate launching the new therapy in the second quarter of 2006.