Track topics on Twitter Track topics that are important to you
Auris Medical has acknowledged the second Phase III failure in 19 months for its tinnitus candidate Keyzilen ® (AM-101), promising a future update on its plans for the company’s co-lead development program. Auris said Keyzilen failed the TACTT3 trial ( NCT02040194 ) by missing its primary efficacy endpoint of a statistically significant improvement in the Tinnitus Functional Score from baseline to day 84 in participants treated with the drug compared to those treated with placebo, either in the overall population or in the otitis media subpopulation. TACTT3, which was conducted in Europe, was designed to assess Keyzilen in acute and postacute inner ear tinnitus following traumatic cochlear injury or otitis media. The trial enrolled a combined 893 participants in the acute tinnitus stage (Stratum A) and the postacute tinnitus stage (Stratum B). The trial’s status was updated to “completed” as of January 16, the date of ...
Original Article: Auris Medical's Tinnitus Candidate Keyzilen Fails Second Phase III TrialNEXT ARTICLE
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...