Auris Medicals otoprotective drug AM-111 has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) for the treatment of acute sensorineural hearing loss (ASNHL), a condition which may occur following various inner ear injuries. ASNHL may be provoked by exposure to excessive noise, viral or bacterial infections in the inner ear, disturbances of the inner ear blood supply, middle and inner ear surgery and a variety of other incidents. If left untreated, ASNHL may result in permanent, irreversible hearing loss. The clinical development with AM-111 was launched in January 2006 with a phase I/II clinical trial evaluating the drugs safety in patients with ASNHL from acute acoustic trauma.
The FDAs orphan drug program is designed to promote the development of treatments for diseases that affect fewer than 200,000 patients in the USA. It provides certain incentives such as waiver of FDA user fees, tax credits, funding support for clinical trials, study design assistance, or market exclusivity for up to seven years following marketing approval. The orphan drug program is administered by the Office of Orphan Products Development.
More information can be found at www.aurismedical.com/
