Otonomy Inc (NASDAQ:OTIC) has published the clinical findings of Phase 3 clinical trials for OTIPRIO.
The publication indicated that the phase 3 trials showed positive results and they were published in the journal by JAMA Otolaryngology- Head & Neck Surgery. The drug trials were carried out in two identical phases that were sham-controlled. They were carried out on 532 pediatric subjects who were going through tympanostomy tube placement (TTP).
Eric A. Mair, the managing director of Charlotte, Eye, Ear, Nose, & Throat Associates, stated that the drug trials showcased the safety levels and efficiency towards bilateral middle ear effusion during ear tube placement in Pediatric patients. He stated that a single dose of the drug offers guaranteed compliance during treatment.
David A. Weber, the president and CEO of Otonomy expressed gratitude to the patients who contributed to the clinical trials as well as their families and physicians. He further added that the pharmaceutical company was pleased with the fact that JAMA Otolaryngology-Head & Neck Surgery decided to publish the results of the trial findings in their journal. He also stated that the company is currently working towards launching the commercialization of the drug in the US. The publication of the trial findings for OTIPRIO in a well-respected journal is expected to help to make the drug more marketable.
The 532 patients two phase 3 trials were distributed around 50 centers in Canada and the US. Pediatric patients who had bilateral middle ear effusion were chosen randomly on the day of surgery to receive tympanostomy tube placement (TTP). The primary efficacy end point was the failure of treatment due to the presence of otorrhea, missed visits through Day 15, failure of following up and the use of otic or systemic antibiotics. The trials recorded at least 3% adverse reactions to the treatment. The company offers a few warnings such as the possibility of increased microbial overgrowth.
Otonomy is a biopharmaceutical firm that is geared towards the development and sale of treatments for disorders and diseases of the ear.