November 4, 2013
Auris Medical reaches Special Protocol Assessment agreement with FDA for pivotal phase III clinical trial with AM-101 in treatment of acute peripheral tinnitus
Auris Medical today announced that it has reached agreement with the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its pivotal phase III trial with the investigational product AM-101 for the treatment of acute peripheral tinnitus. The SPA is an agreement between a trial sponsor and the FDA regarding the design, endpoints and planned statistical analysis of the study to support a New Drug Application (NDA).
The multi-centre, randomized, double-blind, placebo-controlled trial is designed to confirm the efficacy and safety of AM-101 (Esketamine gel for intratympanic injection) in the treatment of acute peripheral tinnitus following traumatic cochlear injury or otitis media. The TACTT2 study will enrol 330 patients aged 18 to 75 years at North American sites; all participants completing the study and continuing to meet certain criteria will be eligible to enter an open label safety study (AMPACT1) and receive up to 3 treatment cycles with AM-101 over up to 9 months.
In parallel, Auris Medical will initiate a second, similarly designed phase III trial (TACTT3) and open label follow-on study (AMPACT2) in several European countries. The TACTT3 study will enrol 600 patients, of which 300 during the acute stage (up to 3 months from tinnitus onset) and 300 during the post-acute stage (4 to 12 months from tinnitus onset). Both TACTT studies are scheduled to start enrolment shortly.
"We appreciate the FDA's input on the pivotal phase III study protocol and look forward to moving forward with our AM-101 development programme", commented Thomas Meyer, Auris Medical's founder and Managing Director. "Together with earlier feedback from a Scientific Advice procedure with the European Medicines Agency this represents another important milestone on our way towards a safe and effective tinnitus therapy", he added.