SAN DIEGO, Nov. 16, 2015 (GLOBE NEWSWIRE) — Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced the enrollment of the first subjects in a Phase 1 clinical safety trial of OTO-311, a product candidate for the treatment of tinnitus. OTO-311 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. This Phase 1 dose escalation clinical safety study is being conducted in normal healthy volunteers. OTO-311 will be given as a single unilateral intratympanic injection and subjects will be observed for four weeks following dosing.
“We are pleased to initiate the clinical development of OTO-311 for tinnitus with the dosing of the first subjects in our Phase 1 clinical safety trial,” said David A. Weber, Ph.D., president and CEO of Otonomy. “We expect to complete this trial in the first half of 2016, and initiate a Phase 2 trial in tinnitus patients during the second half of the year. We believe that a single-dose intratympanic treatment will be of interest to patients and their physicians.”
The American Tinnitus Association reports that approximately 16 million patients in the United States have tinnitus symptoms severe enough to seek medical attention, and about two million patients cannot function on a normal day-to-day basis. Furthermore, the United States Department of Defense reports that tinnitus accounts for the most prevalent service-connected disability among veterans and that the costs of service-related tinnitus are estimated to exceed $2 billion. While the most common cause of tinnitus is exposure to loud noise, a number of other factors can be involved including heart or blood vessel problems, hormonal changes in women, ear and sinus infections, certain medications and thyroid problems. People with severe tinnitus may have trouble hearing, working and sleeping. At this time, there is no cure for tinnitus and there are no FDA-approved drugs for treating this debilitating condition.