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March 27, 2013 /PRNewswire/ --
Novel sodium channel blocker with excellent pharmacokinetic and safety profile could fill treatment gap for severe pain condition
Convergence Pharmaceuticals Limited ("Convergence"), the company focused on the development of novel analgesic medicines for the treatment of chronic pain, today announces positive interim data from the ongoing Phase II clinical trial of novel sodium channel blocker CNV1014802 in patients with trigeminal neuralgia (TN), a very severe form of facial pain.
CNV1014802 is a novel small molecule state-dependent sodium channel blocker that exhibits potency and selectivity against the Nav 1.7 sodium channel. The Phase II study utilises a novel design, whereby eligible patients are entered into a 3-week open-label treatment period with CNV1014802 at a dose of 150mg three times a day (tid). If a successful response is observed in the final week of this period, patients are then randomised to a 4-week double-blind treatment period with either CNV1014802 150mg tid or placebo.
A planned interim analysis was performed once a pre-defined number of patients had completed the 3-week open-label treatment period. Success criteria for individual patient response was defined as a 30% or more reduction in numbers of paroxysms, or severity of paroxysms, relative to the run-in period. A total of 70% patients showed a successful response and were subsequently randomised into the double-blind treatment period. CNV1014802 was well tolerated in these patients. A Data Monitoring Committee (including medical experts in the treatment of trigeminal neuralgia) reviewed all available efficacy and safety data from the open-label treatment period and agreed that the study should continue to completion as defined in the protocol, using the dose regimen of 150mg tid for CNV1014802.
TN is a very severe form of facial pain that is experienced in short bursts or attacks. The International Association for the Study of Pain (IASP) defines TN as sudden, severe, brief, stabbing, recurrent episodes of pain usually on one side of the face and can be provoked by light touch. The pain follows one or more branches of the trigeminal nerve which provides nerve sensation from the mouth, face and the front of the scalp.