Date: 2015-01-30
Type of information: Results
phase: 2
Announcement: results
Company: Biotie Therapies (Finland)
Product: nepicastat (SYN117)
Action
mechanism: dopamine hydroxylase inhibitor. Nepicastat is an orally administered, potent and selective inhibitor of the enzyme dopamine beta-hydroxylase (DBH) which converts dopamine into norepinephrine. Like many other addictions, cocaine dependence is driven by dysregulation in the dopamine-reward system. Inhibition of DBH by nepicastat increases levels of dopamine, which may reduce craving for cocaine, and reduces the levels of norepinephrine, which may decrease the pleasurable responses to cocaine and the potential for stress-induced relapse following withdrawal.
Disease: cocaine dependence
Therapeutic area: CNS diseases
Country: USA
Trial
details: The study is a randomized, double-blind placebo-controlled 11-week trial and is expected to enroll about 180 treatment-seeking cocaine-dependent subjects. The study will be conducted at approximately 12 US clinics specializing in the treatment of drug dependence.
Latest
news: * On January 30, 2015, Biotie Therapies announced top-line results from a Phase 2 clinical study with nepicastat (SYN117) in cocaine-dependent patients. When compared to placebo, nepicastat did not meet the primary efficacy endpoint of an increased proportion of subjects remaining abstinent from cocaine during the last two weeks of the treatment period. Nepicastat was generally well tolerated in the study. A comprehensive analysis of safety and efficacy data is ongoing. The study enrolled 179 treatment-seeking cocaine-dependent subjects in a randomized, double-blind placebo-controlled trial, in which the duration of drug treatment was 11 weeks. The study was conducted at 10 US clinics specializing in the treatment of drug dependence and was funded by the National Institute on Drug Abuse (NIDA) at the US National Institutes of Health under a Collaborative Research and Development Agreement (CRADA). * On December 23, 2014, Biotie Therapies announced that data are currently being analyzed from the NIDA-sponsored Phase 2 study investigating Biotie's DBH inhibitor nepicastat in cocaine dependence. Top-line results from the study are expected to be available during Q1 2015. * On May 27, 2014, Biotie Therapies announced that patient enrollment into the Phase 2 study investigating nepicastat for cocaine dependence has been completed ahead of schedule. The 11-week, 179-patient study is being conducted at 10 US clinics under a Collaborative Research and Development Agreement (CRADA) with the National Institute on Drug Abuse (NIDA) at the US National Institutes of Health. Top-line results from the study are expected around the end of 2014. * On May 10, 2013, Biotie has announced start of a Phase 2 clinical study evaluating nepicastat (SYN117) in cocaine dependence. The National Institute on Drug Abuse (NIDA) at the US National Institutes of Health is funding the conduct of the study under a Collaborative Research and Development Agreement (CRADA) signed in December 2011. The trial is expected to take approximately two years to complete.
