SAN DIEGO, April 18, 2016 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that it has successfully completed an End-of-Phase 2 review with the U.S. Food and Drug Administration (FDA) for OTIPRIO™ (ciprofloxacin otic suspension) in the treatment of acute otitis externa, also known as swimmer’s ear. Based on this review, the company intends to initiate a single Phase 3 clinical trial for OTIPRIO in patients with acute otitis externa during the second quarter of 2016 and expects to complete this trial and report topline results in the fourth quarter of 2016. If the results are positive then Otonomy expects to submit a supplemental New Drug Application (sNDA) to the FDA in the first half of 2017.
“We are extremely pleased with the outcome of our End-of-Phase 2 communications with the FDA including their acceptance of a single Phase 3 trial to support the registration of OTIPRIO for the treatment of acute otitis externa,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Our plan to complete the Phase 3 trial in otitis externa this year and our recent initiation of a Phase 2 trial in pediatric patients with acute otitis media with tympanostomy tubes (AOMT) highlights our strategy to develop and register OTIPRIO for multiple indications. We are also following this approach with OTO-104 which is in two Phase 3 trials in patients with Ménière’s disease and for which we intend to initiate a Phase 2 trial in the second half of 2016 for hearing loss protection in pediatric patients undergoing cisplatin chemotherapy.”
In December 2015, Otonomy announced the completion of a one-month, prospective, multicenter, open label Phase 2 clinical trial that enrolled a total of 75 pediatric and adult patients with acute otitis externa. This trial demonstrated the feasibility of administering OTIPRIO into the external ear canal of a patient in the physician office setting, and a clinical cure rate at both Day 8 and Day 15 of 80% or greater for patients treated with a 0.2 mL dose which is the dose that will be evaluated in the Phase 3 clinical trial.
The one-month, prospective, randomized, double-blinded, sham-controlled, multicenter, Phase 3 clinical trial is expected to enroll approximately 500 patients age 6 months and older with acute otitis externa, in the United States. Subjects will be randomized to receive a single administration of 12 mg OTIPRIO (equal to 0.2 mL) or sham (empty syringe) to the external ear canal of the affected ear(s). The primary endpoint is clinical cure at Day 8 where clinical cure is defined as complete resolution of the signs and symptoms related to acute otitis externa (i.e. tenderness, erythema, and edema) as determined by a blinded clinical assessor. Safety outcome measures will include reporting of adverse events and otoscopic examinations.
About Acute Otitis Externa
Acute otitis externa, also known as swimmer’s ear, is a common condition involving infection and inflammation of the external ear canal typically caused by bacterial infection. According to medical claims data, there are nearly 4 million episodes of acute otitis externa each year in the United States. Symptoms usually appear within a few days of swimming and include itchiness, redness, swelling, pain and pus draining from the infected ear. Antibiotic ear drops are considered the standard of care treatment for acute otitis externa with the typical regimen requiring several administrations to the affected ear each day for up to 10 days.
OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. OTIPRIO is administered by a physician as a single 0.1 mL (6 mg) intratympanic administration into each affected ear, following suctioning of the middle ear effusion. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed. In two Phase 3 trials, a single intraoperative administration of OTIPRIO demonstrated a statistically significant reduction in the cumulative proportion of study treatment failures compared to tubes alone (p-value <0.001).
Important Safety Information for OTIPRIO
Contraindications: OTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO.
Warnings and Precautions - Potential for Microbial Overgrowth: OTIPRIO may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, institute alternative therapy.
Adverse Reactions: Adverse reactions (incidence at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%).
Use in Specific Populations - Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established.
Full prescribing information can be found at www.OTIPRIO.com.
Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic suspension) is approved in the United States for use during tympanostomy tube placement surgery in pediatric patients, and commercial launch commenced in March 2016. OTO-104 is a steroid in development for the treatment of Ménière's disease and other severe balance and hearing disorders. Two Phase 3 trials in Ménière's disease patients are underway, with results expected during the second half of 2017. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that is in a Phase 1 clinical safety trial. Otonomy’s proprietary formulation technology utilizes a thermosensitive gel and drug microparticles to enable single dose treatment by a physician. For additional information please visit www.otonomy.com.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, the timing of initiation and results of the OTIPRIO Phase 3 clinical trial for acute otitis externa, the timing of the submission of the sNDA to the FDA for OTIPRIO for acute otitis externa, the timing of the OTO-104 Phase 2 clinical trial for cisplatin-induced hearing loss, and the timing of results for the two OTO-104 Phase 3 clinical trials in Ménière's disease. Otonomy's expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: Otonomy's limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy's ability to obtain additional financing; Otonomy's dependence on the commercial success of OTIPRIO and the regulatory success and advancement of additional product candidates, such as OTO-104 and OTO-311; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy's ability to adequately demonstrate the safety and efficacy of its product candidates, the preclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy's ability to obtain regulatory approval for its product candidates; side effects or adverse events associated with Otonomy's product candidates; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct preclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of OTIPRIO and product candidates; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to OTIPRIO and its product candidates in the United States and throughout the world; expectations regarding potential market size, opportunity and growth; Otonomy's ability to manage operating expenses; implementation of Otonomy's business model and strategic plans for its business, products and technology; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in Otonomy's Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 7, 2016, and Otonomy's future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Otonomy as of the date hereof. Otonomy disclaims any obligation to update any forward-looking statements, except as required by law.
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