US Food and Drug Administration (FDA) has granted fast track designation for Auris Medical's KeyzilenTM (AM-101) in acute peripheral (inner ear) tinnitus following cochlear injury or otitis media in adults.
Tinnitus, the perception of sound without external acoustic stimulation, is a symptom common to various ear or other diseases. Inner ear tinnitus may be provoked by various injuries to the cochlea, the organ of hearing, such as overexposure to noise or inflammation.
KeyzilenTM (AM-101) is a NMDA receptor antagonist intended for the treatment of acute peripheral (inner ear) tinnitus. The Phase 3 clinical development program includes the TACTT2 and TACTT3 trials. The TACTT2 trial has enrolled approximately 330 patients and is being conducted primarily in North America under a Special Protocol Assessment (SPA) with the FDA. The TACTT3 trial has enrolled approximately 630 patients and is being conducted in Europe. Top-line results from the TACTT2 and TACTT3 trials are expected in August 2016 and in the fourth quarter of 2016, respectively.
"We are very pleased to have received Fast TrTrack designation for Keyzilen from the FDA," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "Acute peripheral tinnitus is a serious condition that negatively impacts the quality of life for those suffering from it, yet there is no clinically proven pharmacological treatment or other effective therapy available."
"We very much appreciate the FDA's support in the development of Keyzilen and look forward to working with the Agency to advance this potential first-in-class treatment," added Andrea Braun, Auris Medical's Head of Regulatory and Quality Affairs.
