Auris Medical Announces Results of Pre-IND Meeting With FDA For AM-201 Program

Auris Medical (NASDAQ:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and mental health supportive care, today announced the results of its pre-Investigational New Drug (pre-IND) meeting with the United States Food & Drug Administration (FDA), where the FDA addressed the Company’s questions and provided guidance on its AM-201 program with intranasal betahistine for the prevention of olanzapine-induced weight gain.

As quoted in the press release:

In its written response, the FDA supported the planned conduct of a multiple dose Phase 1 trial with AM-201 administered to healthy subjects in combination with olanzapine to evaluate the pharmacokinetics, pharmacodynamics, and safety, and to establish proof-of-concept. Further, the FDA endorsed weight gain normalized to baseline body weight versus placebo as reasonable primary efficacy endpoint for a subsequent Phase 2 trial. The Agency deemed the 505(b)(2) pathway appropriate for the AM-201 program as the Company intends to rely on part of its future submission dossier on existing data from other parties and sources.

“We are very pleased with the outcomes of the pre-IND meeting with the FDA as it provided important confirmation and guidance for our AM-201 development plans,” commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “Following this milestone, we look forward to moving ahead with our development program and to continuing our work towards the development of an effective and safe treatment for the prevention of antipsychotic-induced weight gain.”

Click here to read the full press release.