FDA has granted fast track designation for KeyzilenTM in acute peripheral tinnitus following cochlear injury or otitis media in adults
"We are very pleased to have received Fast Track 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."
The Fast Track program was created by the FDA to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. A drug that receives Fast Track designation is granted more frequent access to the FDA to review the drug's development plan and may become eligible for priority review if relevant criteria are met. Additionally, Fast Track designation allows the sponsor to submit parts of the New Drug Application (NDA) for review on a rolling basis as data become 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.
About the KeyzilenTM Phase 3 Clinical Development Program
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.
About Acute Inner Ear Tinnitus
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. Tinnitus may be transitory; however, it may also become permanent. Tinnitus of less than three months of duration is considered acute, while older tinnitus is considered chronic. Inner ear tinnitus often has a serious impact on the ability to sleep, relax, or concentrate, and it may lead to tiredness, irritation, nervousness, despair, frustration, or even depression. As of today, neither a universal standard of care for acute inner ear tinnitus, nor a truly proven and effective treatment method is available.
Комментарии