Interdigital Neuroma Pain Drug 4975 granted orphan drug status

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Anesiva Announces That FDA Grants Orphan Drug Status For Pain Drug

4975 To Treat Interdigital Neuroma

http://www.medicalnewstoday.com/medicalnews.php?newsid=54018

Anesiva, Inc. (Nasdaq: ANSV) announced today that the U.S. Food and

Drug Administration (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, NSAID's (non-steroidal anti-

inflammatory drugs) and injections of corticosteroids, that would

otherwise require removing or chemically destroying the nerve that

causes the pain.

Orphan drug designation is granted by the FDA to encourage companies

to develop products that treat rare diseases and conditions and

includes incentives such as market exclusivity for seven years, tax

credits on qualified clinical trial expenses and a waiver of the FDA

prescription drug user fees.

" 4975 has shown great promise in a number of indications, and the

potential to treat the serious pain associated with interdigital

neuroma, sometimes referred to as Morton's neuroma, offers an

important opportunity for us. There are no drugs approved to treat

this unmet medical need. This condition afflicts approximately

200,000 new patients in the United States each year with about half

of them failing conservative therapy, " said P. McLaughlin,

chief executive officer of Anesiva.

" The long duration of action following a single localized

administration of 4975 offers a unique treatment option to patients

with various types of post-surgical, neuropathic and musculoskeletal

pain conditions by providing pain relief for several weeks following

a single injection without the side effects associated with other

pain medications. "

Interdigital Neuroma and 4975

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, non-

steroidal pain relievers 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. In some

instances, the neuroma regrows causing a return of this painful

condition.

Data from a Phase 2 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 when compared to placebo

treatment.

How 4975 May Address Need for Long-Duration, Well-Tolerated Pain

Relief

4975 is long-acting, with the potential to provide pain relief for

weeks or months after just a single localized treatment. It 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.

In clinical studies to date, 4975 has not had the side effects often

associated with other conventional pain medications and has been

shown to be well tolerated. Opioid drugs, such as morphine, which

are commonly used agents to relieve pain in post-surgical and

musculoskeletal pain conditions, have significant side effects

including sedation, respiratory depression, euphoria, and nausea and

vomiting during acute use, and constipation and physical dependence

during chronic use.