Orphan-drug designation for Nav1.7 blocking pain drug CNV1014802 granted

Date: Jul-31-2013Convergence 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.[1]

Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.