Everything About Oto 313 Tinnitus Drug – FAQs

We do not have a tinnitus drug or an approved medication to get rid of ringing in the ears. Many biopharmaceutical companies are working on this problem and we will have a tinnitus drug very soon. One such tinnitus drug is Oto 313 from Otonomy, it has shown promising results, and if all goes well, we shall soon see Oto 313 receiving approval for use.

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What is Oto 313?

According to the latest research on tinnitus, the biopharmaceutical company Otonomy is conducting the phase 2 trial of the tinnitus drug Oto 313. It is intended to work in cases of cochlear related persistent tinnitus.

How Does Oto-313 Work?

Oto 313 is a formulation of gacyclidine. According to the company, gacyclidine reduces the over-activation of the nerve fibers in the cochlea. The decrease in activation results in reduction of noise in patients with moderate to severe tinnitus.

How Is Oto 313 Administered?

The formulation Oto 313 is administered by a single intratympanic injection of gacyclidine. The tinnitus drug is injected into the middle ear by penetrating the tympanic membrane (ear drum). The Oto 313 injection provides sustained drug exposure in the inner ear.

What are the Oto 313 Results?

A randomized double-bind placebo-controlled clinical study was conducted on 153 patients with moderate to severe unilateral tinnitus.

A 0.32 mg Oto 313 intratympanic injection and placebos were administered in the ratio of 1:1. Change from baseline in tinnitus functional index (TFI) and daily ratings of tinnitus loudness and annoyance were observed.

A tinnitus functional index (TFI) reduction from baseline was observed in patients administered OTO-313 at Week 2, 4, and 8.

Clinically meaningful, 13-point improvement in the TFI was observed in 43% (6/14) of OTO-313 patients at both Weeks 4 and 8 compared to 13% (2/16) of patients administered placebos.

A reduction in tinnitus loudness, annoyance and changes in the patient global impression of change (PGIC) were observed.

What are the Oto-313 Adverse Effects?

A single intratympanic injection of OTO-313 was well-tolerated and patients who received OTO-313 had a lower incidence of adverse events than placebo.

There were no adverse events that led to withdrawal, and a very low incidence of tympanic membrane perforation (one OTO-313 patient each in Parts A and B) which was resolved by the end of the study. There was one serious adverse event (stress cardiomyopathy), but it was not considered related to the study drug.

Most adverse events were ear or injection site-related were mild to moderate in intensity and were resolved by the end of the study.

When is the Oto-313 Release Date?

Phase 2 trial in tinnitus is ongoing with top-line results expected in mid-2022; initiating safety evaluation of higher and bilateral dosing.

In mid-2022 – to announce top-line results for OTO-313 Phase 2 clinical trial.

In the first half of 2023 – Initiate Phase 3 clinical program for OTO-313 in tinnitus.

153 patients suffering from persistent, unilateral, moderate to severe tinnitus were enrolled for the trial.

Based on the successful results additional nonclinical testing and initiation of a 1-month safety study for bilateral tinnitus and higher dosing (0.64 mg) of OTO-313 are being conducted. The results are expected around August 2022.

After sharing the end of the phase 2 data with the FDA, Otonomy plans to start Phase 3 clinical program in the first half of 2023.

Does Oto 313 Work for Somatic Tinnitus?

Oto-313 tinnitus drug is not for somatic tinnitus. It is being studied as a potential treatment for tinnitus of cochlear origin. It should work well in subjective tinnitus associated with sensorineural hearing loss, traumatic cochlear injury, and ototoxic drug exposure.

At present, there is no cure or approved medications to treat tinnitus. Current management focuses on various therapies to reduce tinnitus. Readers can explore 11 tinnitus therapy techniques for relief from tinnitus.

References:
https://pubmed.ncbi.nlm.nih.gov/34629442/
https://ichgcp.net/clinical-trials-registry/NCT04829214
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8584222/
https://clinicaltrials.gov/ct2/show/NCT04829214

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