Auris Medical Inc. (NASDAQ: EARS) stock gains by 25.08% in the current market trading. Auris Medical is a clinical-stage pharmaceutical organization focused on developing treatments for unmet medical needs in neurotology, rhinology, asthma, and CNS disorders. EARS is working on intranasal betahistine for the cure of vertigo (AM-125, in Phase 2) and the reduction of antipsychotic-induced weight gain and somnolence (AM-201, post-Phase 1b).
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EARS and its subsidiary Altamira Medica Ltd. today presented more information on the results of its BentrioTM nasal spray clinical trial in allergic rhinitis, as well as an update on the regulatory pathway in the United States for the planned use in allergy.
BentrioTM was studied in 36 patients with allergic rhinitis to grass pollen in an open-label random cross-over study. Prior to four hours of managed pollen exposure in an allergen test environment, study members were provided a single dose of BentrioTM nasal spray or a placebo. Following a wash-out cycle, the challenge was repeated with the alternative procedure. The study found Bentrio’s beneficial effect to have a fast onset and long duration, provided significant equivalence to the advertised comparator with higher efficacy scores from patients and clinicians, and demonstrated good tolerability.
Altamira Medica met with the FDA for a pre-submission consultation on a 510(k) pre-market notification proposal on May 6, 2021. BentrioTM is expected to be submitted for regulatory approval under the 510(k) pathway for its planned application in allergy. At the conference, EARS was able to collect crucial details that would aid in the completion of the submission kit. Also, it was being stated that the pollen challenge study’s architecture seemed sufficient to facilitate the proposed 510(k) request.