FDA grants orphan-drug designation to Convergence's CNV1014802 for treatment of TN

Convergence Pharmaceuticals LtdJul 30 2013

Designation granted by US FDA for the treatment of trigeminal neuralgia

Convergence Pharmaceuticals Limited ("Convergence" or "the company"), the company focused on the development of novel and high value analgesic medicines for the treatment of chronic pain, is pleased to announce that its novel sodium channel blocker, CNV1014802 ('802), has been granted orphan-drug designation by the US Food and Drug Administration for the treatment of trigeminal neuralgia (TN). Orphan-drug designation gives Convergence various incentives and advantages in the development of '802, including the potential availability of certain grants for clinical studies and assistance from the FDA with clinical protocol design. Furthermore orphan drug designation grants US market exclusivity, distinct from other types of exclusivity, for seven years if '802 is approved.

TN is a very severe form of facial pain that is experienced in short bursts or attacks called paroxysms. 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.

'802 is a novel small molecule that penetrates the central nervous system (CNS) and blocks Navs in a highly state-dependent fashion, while exhibiting selectivity against the 1.7 subtype. '802 is currently undergoing clinical evaluation in an innovative Phase II trial. An interim analysis from the trial reported in March that 70% of patients showed a successful response and were subsequently randomised into the double-blind treatment period. '802 was safe and well tolerated in these patients.

Clive Dix, Chief Executive Officer of Convergence Pharmaceuticals, commented: "This is a highly significant milestone for Convergence coming fast on the heels of positive interim data for '802. Trigeminal neuralgia is a highly debilitating disorder and current pain treatments come with a severe cost to quality of life. Orphan-drug designation will further smooth the path for the successful development of this novel sodium blocker and offer market exclusivity in the US if approved."