As previously reported, results from this study showed OTO-104 to be safe and well-tolerated at both doses tested when delivered via a single IT injection. It is important to note that despite demonstrating meaningful clinical activity in the areas of vertigo and tinnitus, this study was not powered to demonstrate statistical significance. Based on these study results, Otonomy will initiate a Phase 2 clinical trial of OTO-104 in Meniere's disease during the fourth quarter of 2011.
"These new results provide the first demonstration of OTO-104's clinical activity in a cohort of Meniere's disease patients experiencing frequent vertigo episodes," stated Paul R. Lambert, M.D., professor and chair of the department of otolaryngology – head and neck surgery, Medical University of South Carolina, and the study's lead investigator. "Furthermore, the continued reduction in vertigo frequency and improvement in tinnitus symptoms for the 12 mg OTO-104 group observed through three months of follow-up provides a strong rationale for initiating broader clinical evaluations of this sustained release product."
A total of 44 patients with unilateral Meniere's disease were enrolled in this prospective, randomized, double-blind, placebo-controlled multicenter study. Patients participated in a one-month baseline period to characterize disease status, followed by randomization to receive a single IT injection
|SOURCE Otonomy, Inc.|
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