EARS - Auris Medical updates on pollen challenge study for nasal spray

Auris Medical (EARS) climbed ~16.6% on Friday in apparent reaction to updates from a pollen challenge trial for its drug-free nasal spray, Bentrio.The open-label randomized cross-over trial in 36 patients has met the primary efficacy endpoint in allergic rhinitis after a single dose of Bentrio before a controlled pollen exposure for four hours.Under Bentrio therapy, the patients reported a mean increase in the Total Nasal Symptom Score (TNSS; averaged over 4 hours in 20-minute intervals) of 4.75 points. It was 1.11 points when exposed to pollen without nasal spray protection (95% confidence interval, CI: -1.61 to -0.61).A 1-point reduction in the TNSS is clinically relevant, the company said.With the comparator treatment, the TNSS increased on average 5.14 points, 0.71 points lower than when unprotected (CI: -1.21 to -0.21).On May 06, Auris-affiliate Altamira Medica has conducted a pre-submission meeting with the FDA in connection with the 510(k)-pre-market notification application for Bentrio, and the regulator has

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Auris Medical updates on pollen challenge study for nasal spray