The AudioNotch Tinnitus Treatment Blog

AM101, a drug for treating the acute development of tinnitus, is entering Phase 3 clinical trials. 

Auris Medical today announced enrollment of the first patient into the TACTT2¹ clinical trial. This phase 3 trial will evaluate the efficacy, safety and tolerability of intratympanic injections of AM-101 in the treatment of acute peripheral tinnitus following traumatic cochlear injury or otitis media. TACTT2 will enroll 330 patients at more than 60 sites primarily in the United States and Canada.

The initiation of the TACTT2 trial follows shortly after the start of TACTT3, its European counterpart. Both have been designed as pivotal double-blind, placebo-controlled trials and are part of Auris Medical’s phase 3 development program with AM-101. All participants completing one of the TACTT studies and continuing to meet certain criteria will be eligible to enter an open label safety study (AMPACT1, respectively AMPACT2)² and receive up to three treatment cycles with AM-101 over up to nine months.

Thomas Meyer, Auris Medical’s founder and CEO, commented: “It is an exciting moment for the company to have both phase 3 trials underway. TACTT2 and TACTT3 are based on more than 10 years of research and development and represent the largest clinical trials ever conducted with an intratympanic treatment.” He added: “The phase 3 program will be an essential step in our quest for developing the first specific therapeutic for acute peripheral tinnitus, a condition without any effective and safe treatment options. We expect results from both TACTT2 and TACTT3 trials in late 2015.”

AM-101 is an exciting drug – but there’s a limitation: it’s for acute peripheral tinnitus. Basically, they’re trying to prevent the cochlear cell death that precedes the centralization of the tinnitus (meaning, the self-propagating circuit shifts from a peripherally based problem to a centrally based problem, which is an inherently harder therapeutic target).

For chronic tinnitus, other treatments are still going to be the modality of choice.