Following in the footsteps of Selincro, its recently-launched drug to cut alcoholic urges, Biotie Therapies Corp has started a mid-stage study of nepicastat for cocaine dependence.
The Finnish drugmaker noted that an 11-week Phase II study, with funding from the US National Institute on Drug Abuse, is expected to enroll about 180 treatment-seeking cocaine-dependent subjects. The study will be conducted at 12 US clinics specialising in the treatment of drug dependence and is expected to take two years to complete.
Nepicastat is an oral inhibitor of dopamine beta-hydroxylase (DBH) which converts dopamine into norepinephrine. Cocaine dependence is driven by dysregulation in the dopamine-reward system, Biotie notes, and inhibition of DBH by nepicastat may reduce cravings. Cutting the levels of norepinephrine could decrease the pleasurable responses to cocaine and the potential for stress-induced relapse following withdrawal.
Biotie has previously conducted a Phase IIa study in non-treatment seeking addicts, which showed that nepicastat had a favourable safety profile and was well tolerated when administered with cocaine.
The drug has also been evaluated for post-traumatic stress disorder but recently failed in a Phase II study. Biotie is evaluating data from the trial in further detail before deciding what to do with nepicastat in PTSD.
Biotie is on a good run at the moment, due principally to partner Lundbeck's recent roll-out in northern Europe of Selincro (nalmefene), the firms' alcohol dependency drug. The Turku-based firm holds all the rights to nepicastat.