auris medical hearing loss treatment

Auris Medical Receives FDA Guidance for Investigative Drug to Treat Sudden Sensorineural Hearing Loss

ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced today that it has received 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, the company’s investigational treatment for sudden sensorineural hearing loss. The meeting had been conducted at the request of…

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auris medical hearing loss drug failure

Auris Medical to Terminate Hearing Loss Drug Trial After Disappointing Results

ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced today that it is terminating a late-stage study to treat sudden sensorineural hearing loss (SSNHL) with its investigational drug, AM-111. The company had been evaluating the drug in two late-stage studies, Healos and Assent. The data from Healos study found that AM-111 was not statistically significant in…

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tinnitus drug treatment auris medical

Auris Medical Announces it Has Completed Enrollment for Phase 3 Trial of Tinnitus Drug, Keyzilen

ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced today that it  has completed patient enrollment in the Phase 3 TACTT3 clinical trial of Keyzilen, in acute and post-acute peripheral (inner ear) tinnitus. The company’s investigative drug, Keyzilen, is esketamine gel for intratympanic injection, intended for acute peripheral tinnitus following cochlear injury or otitis media in…

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menieres drug auris medical otifex

Auris Medical Acquires Meniere’s Drug, AM-125, from Otifex Therapeutics for Further Development

ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced today that it has completed the acquisition of assets related to intranasal betahistine from Otifex Therapeutics Ltd. The assets acquired by Auris Medical, including preclinical and clinical data, as well as intellectual property rights, have been fully transferred to Auris Medical according to the announcement. Together the assets form the…

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auris medical hearing loss am-111

Auris Medical Completes Enrollment of Phase 3 Trial of AM-111 Drug, to Treat Sudden Sensorineural Hearing Loss

ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced today that it  has completed patient enrollment in the Phase 3 trial of its novel AM-111 drug, to treat idiopathic sudden sensorineural hearing loss (ISSNHL)–also known as sudden deafness. Results from the trial are anticipated to be available in the fall of this year.   HEALOS Trial…

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tinnitus drug pharma hearing loss

FDA Fast Tracks Tinnitus Drug; Meniere’s Drug Completes Year-Long Safety Trial

ZUG, SWITZERLAND — Biopharmaceutical company Auris Medical Holdings announced late last month that the US Food and Drug Administration (FDA) granted Fast Track designation to its investigational drug, KeyzilenTM (AM-101).  Keyzilen is esketamine gel for intratympanic injection, intended for acute peripheral tinnitus following cochlear injury or otitis media in adults.  The Fast Track designation by the FDA of an…

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