Patients administered 4975 have not responded to the current treatments such as such as foot pads, non-steroidal anti-inflammatory drugs and injections of corticosteroids and would otherwise had the nerve causing the pain removed.
The standard treatments for interdigital neuroma fail in approximately 50% of patients.
Orphan drug designation is granted by the FDA to encourage companies to develop products that treat rare diseases and conditions. The status has benefits which include market exclusivity for seven years, tax credits on qualified clinical trial expenses and a waiver of the FDA prescription drug user fees.
Data from a phase II clinical trial in patients with interdigital neuroma demonstrated that 4975 produced a statistically significant reduction in foot pain for four weeks following a single injection when compared to placebo treatment.
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.