Vivitrol gets approvable letter

After market close, Alkermes (ALKS) and Cephalon (CEPH) said they received an approvable letter from FDA for Vivitrol (formerly Vivitrex) injectable extended-release naltrexone to treat alcohol dependence. The letter requested additional preclinical pharmacokinetic data to support reference to existing preclinical data for oral naltrexone. ALKS spokesperson Rebecca Peterson said the company is evaluating FDA's request to determine whether additional preclinical work is necessary. If an additional study is needed, the company expects the duration to be "brief" and does not expect it to change the timeline for product launch, which is planned for the second quarter of 2006. ...