Convergence Pharmaceuticals Limited, 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).
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.”
About Trigeminal Neuralgia (TN)
TN currently affects approximately 50,000 people in the USA alone. The majority of people affected are over 50 years of age; however, many cases have been reported in young adults. TN is more prevalent in women than men, and for most sufferers, the condition is progressive and worsens over time. TN is commonly misdiagnosed and to date there is no guaranteed cure for the condition. Current therapies are centred on sodium channel blockers such as carbamazepine or oxcarbazepine as first-line treatments. However, these agents, although providing relief, are often poorly tolerated, and require lengthy dose escalation, resulting in sub-optimal efficacy.
About chronic pain
Currently, more than 1.5 billion people worldwide suffer from chronic pain of varying degrees. Among all types of chronic pain, neuropathic pain stands out with approximately 3-4.5% of the global population affected, with incidence rate increasing in line with increased age of the population. With the unmet clinical need so high, the demand for better pain management therapies, addressing acute and chronic pain, is on the rise.
According to recent research the global pain management market is to reach US$60 Billion by 2015.
* 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.
1) Global Industry Analysts Inc. 2010, “Pain Management: A Global Strategic Business Report“.