Auris Medical Receives FDA Guidance at Type C Meeting for AM-111 in the Treatment of Sudden Sensorineural Hearing Loss
Auris Medical (NASDAQ:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and mental disorders supportive care, announced today feedback from a Type C meeting with the U.S. Food and Drug Administration (FDA) related to the development plan and regulatory pathway for AM-111, its investigational treatment for sudden sensorineural … Continued
Auris Medical (NASDAQ:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and mental disorders supportive care, announced today feedback from a Type C meeting with the U.S. Food and Drug Administration (FDA) related to the development plan and regulatory pathway for AM-111, its investigational treatment for sudden sensorineural hearing loss.
As quoted in the press release:
The Type C meeting had been requested by the Company following the results of the HEALOS phase 3 trial. The results showed, based on a post-hoc analysis, a clinically meaningful and nominally significant improvement in hearing for the AM-111 0.4 mg/mL group compared to placebo in the subpopulation of patients with acute profound hearing loss. These patients were initially completely deaf or almost deaf on the affected ear and normally would have faced a particularly poor prognosis for hearing recovery.
The FDA reviewed the Company’s proposed concept for a placebo-controlled pivotal trial with AM-111 0.4 mg/mL in patients suffering from acute profound hearing loss. The trial protocol builds to a large extent on the design and outcomes from HEALOS and also incorporates specific feedback provided by the European Medicines Agency (EMA) earlier this year. In a written response the FDA endorsed the proposed choice of primary and secondary efficacy endpoints, the safety endpoints, as well as the planned sample size and statistical methodology. In addition, the FDA provided important guidance on the regulatory path forward.
