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Otonomy's Otividex successful in second late-stage Ménière’s study; shares up +136% after hours

Nov. 8, 2017 4:52 PM ET|About: Otonomy (OTIC)|By: Douglas W. House, SA News Editor
A Phase 3 clinical trial, AVERTS-2, assessing Otonomy's (NASDAQ:OTIC) OTIVIDEX in patients with Ménière’s disease achieved its primary endpoint of the number of vertigo days compared to placebo. Specifically, patients in the treatment group experienced an average reduction of 6.2 vertigo days from baseline to month 3 compared to an average reduction of 3.7 days for placebo (p=0.029).

The company plans to review the data with the FDA and the requirements for a marketing application for the indication.

An earlier Phase 3, AVERTS-1, failed to achieve the primary endpoint and any of the secondary endpoints due, in large part, to a higher-than-expected placebo response.

OTIVIDEX (formerly OTO-104), a sustained-exposure formulation of the steroid dexamethasone, was being developed to treat a range of balance and hearing disorders. It is administered directly into the middle ear via injection through the eardrum. The company stopped development and reduced headcount after AVERTS-1.

Shares are up 136% after hours on robust volume.

Previously: Otonomy restructures after Otividex flop; 1/3 of non-commercial workforce cut; shares up 1% premarket (Sept. 13)

Previously: Otonomy's Otividex flunks late-stage study in Ménière’s disease (Aug. 30)
https://seekingalpha.com/news/3310123-otonomys-otividex-successful-second-late-stage-meniere-s-study-shares-136-percent-hours