SAN DIEGO, July 28, 2015 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced the enrollment of the first patients in a Phase 2 clinical trial evaluating AuriProTM for the treatment of patients with acute otitis externa, also known as swimmer's ear. The study is designed to evaluate the feasibility of administering AuriPro to the ear canal in a physician's office setting.
The U.S. Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) action date of December 25, 2015 for Otonomy's New Drug Application (NDA) for AuriPro, a sustained-exposure formulation of the antibiotic ciprofloxacin, as a treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery.
"Swimmer's ear is a common infection that affects an estimated 2.4 million people each year in the United States with a subset of these patients referred to an ENT specialist after failing treatment with antibiotic ear drops that require multi-dose, multi-day administration," said David A. Weber, Ph.D., president and CEO of Otonomy. "AuriPro has a potential advantage by providing a full course of treatment with a single dose that can be administered by the ENT in the office. We look forward to evaluating the feasibility of AuriPro in this additional indication that further expands the product's clinical experience to the external ear."
The one-month, prospective, multicenter, open-label Phase 2 clinical trial is expected to enroll approximately 75 patients, ages 6 months to 80 years old, in the United States. The trial is designed to characterize safety and procedural factors associated with AuriPro administered in subjects with unilateral otitis externa. Subjects will be randomized to receive a single administration of AuriPro ranging in volume from 0.1 mL to 0.4 mL.
AuriPro is a sustained-exposure formulation of the antibiotic ciprofloxacin in development for the treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery. AuriPro has been formulated to provide sustained-exposure of ciprofloxacin so that a single administration provides a full course of treatment. There are approximately one million TTP surgeries performed each year in the United States, and antibiotic ear drops are used in nearly all cases. Despite their routine use, no antibiotic ear drop has received FDA approval for this indication. Moreover, current ear drop products require multi-dose, multi-day regimens for efficacy. Full compliance with these regimens can be challenging, and missed antibiotic doses can compromise efficacy and increase the potential for bacterial resistance.
The FDA has assigned a PDUFA action date of December 25, 2015 for the company's New Drug Application (NDA) for AuriPro for the treatment of middle ear effusion in pediatric patients undergoing TTP surgery. If approved within the standard review period, Otonomy anticipates a commercial launch for AuriPro in the United States in the first quarter of 2016.
AuriPro is also being evaluated in two Phase 2 clinical trials, the first for pediatric patients with acute otitis media with tympanostomy tubes (AOMT) and the second for patients with otitis externa.
Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. Otonomy's proprietary technology provides sustained exposure of drugs to the ear following a single administration. Otonomy has three product candidates in development. AuriPro™ is an antibiotic that has completed Phase 3 clinical trials in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery, and the FDA has assigned a PDUFA action date of December 25, 2015 for the company's New Drug Application. OTO-104 is a steroid that has recently completed a Phase 2b clinical trial in 154 patients with Ménière's disease. Based on these results, Otonomy intends to initiate two parallel Phase 3 trials for OTO-104 in Ménière's disease patients with at least one trial initiated by the end of 2015. OTO-311 is an NMDA receptor antagonist in development as a treatment for tinnitus. 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 Otonomy's future financial or operating performance. Forward-looking statements in this press release include, but are not limited to, the potential advantages of AuriPro for patients with acute otitis externa, Otonomy's expectations regarding enrollment for the Phase 2 clinical trial evaluating AuriPro for the treatment of patients with acute otitis externa, and Otonomy's expectations regarding the commercial launch of AuriPro in the United States. 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: 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 of product candidates, 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; developments related to competitors and the industry; Otonomy's dependence on third parties to conduct preclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of products; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to product candidates in the United States and throughout the world; and other risks. Otonomy undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
The factors referred to above that could cause the Company's results to differ materially from those expressed or implied by such forward-looking statements also include the risks, uncertainties and assumptions discussed from time to time in the Company's public filings and public announcements, including the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2015 which was filed with the Securities and Exchange Commission ("SEC") on May 12, 2015, as well as other documents that may be filed by the Company from time to time with the SEC.
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