Otonomy starts Phase 1/2 trial of OTO-313 for tinnitus


Otonomy (NASDAQ:OTIC) initiated a Phase 1/2 trial of OTO-313, a novel formulation of gacyclidine, for the treatment of tinnitus.

Patients with tinnitus experience noise or ringing in their ears. Otonomy notes that some 10% of U.S. adults are affected by the condition.

OTO-313 is a sustained-exposure formulation of gacyclidine, an N-methyl-D-aspartate receptor antagonist, that is administered via a single intratympanic injection.

“Tinnitus is a common problem affecting millions of people. Unfortunately, we currently have no drug therapy to offer these patients. I am excited about the potential of OTO-313 and pleased to be part of the Phase 1/2 clinical trial,” Susan Marenda King, neurotologist and otologist at the Ear Medical Group in San Antonio, said in a statement.

Following an initial safety cohort, an exploratory efficacy study will be conducted in approximately 50 patients with tinnitus. Otonomy expects results of the trial in the first half of 2020.

Sydney Stewart