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news.Clinical-stage biopharmaceutical firm Otonomy has received approval from the US Food and Drug Administration (FDA) for its investigational new drug application (IND) for tinnitus product candidate, OTO-311.
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OTO-311 is a sustained-exposure formulation of potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine.
The approval has been granted to commence a Phase I dose escalation clinical safety trial of OTO-311 in normal healthy volunteers.
In the trial, the company will give OTO-311 as a single unilateral intratympanic injection and subjects will be monitored for four weeks following dosing.
Otonomy president and CEO Dr David Weber said: "Despite the debilitating nature of tinnitus that impacts millions of Americans, including a high proportion of military veterans, there is no cure and there are no FDA-approved drug treatments.
"Initiating this Phase 1 trial for OTO-311 before the end of 2015 meets our commitment to investors and also serves as an important first step towards our goal of bringing a single-dose intratympanic treatment to tinnitus sufferers."
In 2013, Otonomy purchased certain assets and rights to intellectual property related to the use of gacyclidine to treat tinnitus from an affiliate of NeuroSystec.
In 2014, the firm signed exclusive license agreement with Ipsen to use its clinical and non-clinical gacyclidine data to support worldwide development and regulatory filings for OTO-311.
According to the American Tinnitus Association, around 16 million patients in the US have symptoms of tinnitus, which is the medical term for hearing noise when there is no outside source of the sound.