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Biotie tests cocaine dependence treatment in USA
  Pharmatimes World News | December 14, 2011

Finland's Biotie Therapies Corp has signed a deal with the National Institute on Drug Abuse at the US National Institutes of Health to investigate nepicastat in the treatment of cocaine dependence.

Under the terms of the pact, NIDA will fund the trial, lasting 11 weeks, in 180 treatment-seeking cocaine-dependent subjects using nepicastat, which is also known as SYN117. The study will be conducted at 12 clinics across the USA which specialise in the treatment of drug dependence.

Timo Veromaa, Biotie's chief executive, said the firm is looking forward to working with NIDA "and some of the world's most renowned investigators of treatments for cocaine dependence". There is currently no approved therapy for the problem, he added, "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 interactions between nepicastat, a selective inhibitor of the enzyme dopamine beta-hydroxylase, and drugs of abuse. The compound, which was licensed from Roche in 2007, is also in a Phase II study for the treatment of post-traumatic stress disorder, funded by the US Department of Defence.

The cocaine trial is expected to start in the first half of 2012 and will take two years to complete. Biotie's most advanced product, nalmefene for alcohol dependence, has completed Phase III studies run by licensing partner Lundbeck.


SYN117 for the treatment of cocaine dependency and post traumatic stress disorder (PTSD)

SYN117 is an orally administered, potent and selective inhibitor of the enzyme dopamine ß-hydroxylase (DBH) which has potential application in the treatment of cocaine dependency and post traumatic stress disorder (PTSD). Cocaine dependency represents a major unmet medical need which has a large economic and social burden to society and for which there are currently no approved therapies. Like many other addictions, cocaine dependency is driven by a dysregulation in the dopamine reward system. Mechanistically, inhibition of DBH by SYN117 increases levels of dopamine (which reduces the craving for cocaine) and reduces the levels of norepinephrine (which decreases the pleasurable responses to cocaine and the potential for stress induced relapse following withdrawal). Biotie has conducted a placebo controlled Phase 2a study in non-treatment seeking cocaine addicts. This study showed that SYN117 was safe and well tolerated when administered with cocaine and that SYN117 reduces the pleasurable response to cocaine. Biotie is in discussions with the National Institute of Drug Abuse and with the Veterans Affairs Hospital concerning the funding of a study to evaluate the effect of this promising drug in treatment seeking cocaine addicts. SYN117 is also in a Phase 2 study for the treatment of PTSD that is being funded by the US Department of Defence. PTSD is a condition with significant unmet medical need and with a growing prevalence in both the civilian and military communities. The ongoing study is a placebo controlled, double blind study that is scheduled to enrol 120 patients and is expected to complete in 2013.

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