Date: 2011-12-13
Type of information: Clinical research agreement
Compound: nepicastat (SYN117)
Company: Biotie Therapies (Finland) National Institute on Drug Abuse (NIDA-USA)
Therapeutic area: CNS diseases - Mental diseases
Type agreement: clinical research
Action mechanism:
Disease: cocaine dependence
Details: Biotie Therapies has signed a Collaborative Research and Development Agreement (CRADA) 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. The study will be conducted at approximately 12 US clinics specializing in the treatment of drug dependence. 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.
Financial terms: 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.
Latest news:
