FDA GRANTS ORPHAN DRUG STATUS TO ANESIVA'S PAIN DRUG

Anesiva has announced that the FDA granted orphan drug status to product candidate 4975 for the treatment of a painful condition in the foot known as interdigital neuroma in patients who fail conservative treatments, such as foot pads, non-steroidal anti-inflammatory drugs (NSAIDs) and injections of corticosteroids, that would otherwise require removing or chemically destroying the nerve that causes the pain.

Interdigital neuroma is highly painful and has been described as feeling like walking on a hot pebble or having a hot poker thrust between the toes. This type of post-traumatic neuropathic pain is most often caused by compression of the nerves between the foot bones from running, wearing high narrow shoes and excessive standing. Treatment for interdigital neuroma currently includes orthotics, NSAIDs and steroid injections, which fail in approximately 50 percent of patients. Surgical removal of the neuroma may lead to lengthy painful rehabilitation, and like other treatment options that chemically destroy the affected nerve, result in permanent numbness in that portion of the foot.

Data from a Phase II clinical trial in patients with interdigital neuroma who previously failed treatments with conservative options, such as orthotics and steroid injections, demonstrated that 4975 produced a statistically significant reduction in foot pain for four weeks following a single injection compared with placebo treatment.

The drug, 4975, is a non-opioid TRPV1 agonist with a unique mechanism of action that provides a long-lasting, localized effect on C-fibers and blocks the transmission of aching, throbbing pain caused by major surgical procedures. Because it selectively acts on pain-sensing nerve endings, 4975 does not affect other nerve fibers necessary for sensory or motor sensations, such as those needed to sense temperature or pressure.