The US Food and Drug Administration issued an approvable letter for Vivitrol (naltrexone for extended-release injectable suspension), which is under review for the treatment of alcohol dependence in combination with a treatment programme that includes psychosocial support.
According to a company release, the new drug application (NDA) for Vivitrol, formerly known as Vivitrex, was submitted on March 31, 2005. Alkermes Inc and Cephalon Inc continue to prepare for the launch of Vivitrol during the second quarter of 2006.
FDA approval of Vivitrol is contingent upon finalising the product label and satisfying a request by the FDA for preclinical pharmacokinetic data to support reference to existing oral naltrexone preclinical data.
"This approvable letter is a positive step toward the approval of Vivitrol. We look forward to working diligently with the FDA to gain final approval and bring forward Vivitrol as an important new medication for the treatment of alcohol dependence," stated Richard Pops, CEO of Alkermes.
"Our plans for the launch of Vivitrol in the second quarter of 2006 are on track. We are hiring sales representatives and designing education and training programmes to ensure that physicians and counsellors can identify patients who could benefit the most from the inclusion of this medication in their treatment plan," said Frank Baldino, chairman and CEO of Cephalon.
Alkermes Inc. is a pharmaceutical company that develops products based on sophisticated drug delivery technologies to enhance therapeutic outcomes in major diseases.
Cephalon Inc. is an international biopharmaceutical company that discovers, develops and markets innovative products to treat sleep and neurological disorders, cancer and pain.