Clinical Study on Biotie's Nepicastat in Cocaine Dependence
Biotie Therapies has announced that it has signed a Collaborative Research and Development Agreement with the National Institute on Drug Abuse (NIDA) at the US National Institutes of Health.
Under the agreement, NIDA and Biotie will investigate the safety and efficacy of Biotie's nepicastat (SYN117) in the treatment of cocaine dependence. NIDA will fund the conduct of a randomized, double-blind placebo-controlled trial, lasting 11 weeks, in 180 treatment-seeking cocaine-dependent subjects using nepicastat supplied by Biotie. The study will be conducted at approximately 12 US clinics specializing in the treatment of drug dependence.
"We are pleased to be working with NIDA and some of the world's most renowned investigators of treatments for cocaine dependence," said Timo Veromaa, Chief Executive Officer of Biotie. "There is currently no approved treatment for cocaine dependence, a condition which exacts a heavy toll on individuals, their families and society as a whole."
Biotie and NIDA have previously collaborated on preclinical studies evaluating potential pharmacokinetic and pharmacodynamic interactions between nepicastat and drugs of abuse. Biotie retains rights to nepicastat and will be able to use data from studies conducted with NIDA to support future potential regulatory submissions.
The trial is expected to start in H1 2012 and take approximately two years to complete.
There is already ongoing clinical study on nepicastat in post-traumatic stress disorder, funded and conducted by US Department of Defense, expected to complete in H2 2012.