Auris Med Completes Patient Recruitment For Phase III TACTT3 Trial Of Keyzilen In Acute And Post-Acute Tinnitus
Published: Sep 22, 2017
"We are pleased to complete the recruitment of patients for TACTT3, our pivotal trial with Keyzilen® in
TACTT3 is a randomized, double-blind, placebo-controlled Phase 3 trial in inner ear tinnitus following traumatic cochlear injury or otitis media. As previously announced, the TACTT3 protocol was amended based on analysis of the TACTT2 Phase 3 trial outcomes. The primary efficacy endpoints for the trial include either the improvement of tinnitus loudness or improvement in Tinnitus Functional Index score. In addition, the amended protocol includes certain patient subgroups in confirmatory statistical testing and the trial size was increased.
About Acute Inner Ear Tinnitus
Tinnitus is the perception of sound without external acoustic stimulation. Tinnitus of the inner ear may be caused by various injuries to the cochlea, the organ of hearing, such as overexposure to noise. Tinnitus that has been present for less than three months is considered acute, while tinnitus that has been present for over three months is considered chronic. Tinnitus of the inner ear often has a serious impact on ability to sleep, relax or concentrate, which may lead to tiredness, irritation, anxiety or depression. There is no universal standard of care for tinnitus of the inner ear and efficacy of a pharmacological treatment for tinnitus of the inner ear has not yet been conclusively demonstrated.
About Keyzilen® (AM-101)
Keyzilen® is a small molecule N-methyl-D-aspartate (NMDA) receptor antagonist formulated in a biocompatible gel and delivered by intratympanic injection. Keyzilen® is in development for treatment of acute tinnitus of the inner ear. Emerging evidence suggests that NMDA receptors in the cochlea play a major role in the occurrence of tinnitus following acute injury to the inner ear, e.g. from exposure to excessive noise, infections, disturbances in inner ear blood supply, or the administration of certain ototoxic drugs. Persistent overexpression of NMDA receptors may lead to pathologic excitation of auditory nerve fibers, which in the brain is perceived as tinnitus. The development of Keyzilen® is based on research conducted at the