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.