Auris Medical develops protocol for new Phase II/III trial of Keyzilen to treat acute tinnitus following traumatic cochlear injury
Auris Medical announced that it has developed a protocol for Phase II/III trial with Keyzilen / AM-101. The Company has completed the design of a new Phase II/III trial for its late-stage Keyzilen program. The trial shall, in two stages, reaffirm the compound’s efficacy in the treatment of acute tinnitus following traumatic cochlear injury and provide confirmatory efficacy data to support a filing for marketing authorization.
It will incorporate learnings from the four late-stage trials, TACTT2, TACTT3, AMPACT1 and AMPACT2, notably with regard to the collection of patient reported outcomes and certain elements of study conduct. In addition, it will explore the use of a novel method for objective tinnitus diagnosis and measurement. The Company has solicited advice on the development plan and regulatory pathway from the FDA in the context of a Type C meeting and from the European Medicines Agency in the context of a Scientific Advice procedure.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins