SAN DIEGO, March 02, 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 the commercial launch of OTIPRIO (ciprofloxacin otic suspension) in the United States. OTIPRIO was approved by the U.S. Food and Drug Administration (FDA) in December 2015 for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement (TTP). OTIPRIO is a single-dose, physician-administered antibacterial and the first product approved by the FDA for this indication.
“We have moved quickly following the approval of OTIPRIO in mid-December to hire, train and field an experienced sales force totaling 40 representatives who are already calling on target physicians and facilities,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Interest in joining our team was tremendous with approximately 1,900 resumes received, and we were extremely pleased with the quality of candidates who have an average of 15 years of experience including hospital-based selling which we expect to leverage in gaining access for OTIPRIO.”
Otonomy is commercializing OTIPRIO using an internal sales force of 40 representatives that will cover approximately 2,000 physicians and 800 facilities that account for nearly 70% of the one million TTP procedures performed each year in the U.S., 85% of which are in pediatric patients. The company has also hired a team of field-based medical science liaisons (MSLs) and expects that they will play an important role in providing medical information about OTIPRIO to clinicians and other health care professionals. As of March 1, 2016, Otonomy has shipped OTIPRIO product to a network of specialty distributors who will fulfill orders received from hospital and ambulatory surgery center customers.
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
About Tympanostomy Tube Placement Surgery
According to the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF), tympanostomy tube placement (TTP) surgery is the most common ambulatory surgery performed on children. Overall, there are approximately one million TTP procedures performed each year in the United States of which 85% are in pediatric patients, who typically have middle ear effusion and receive tubes in both ears (bilateral). The tubes are placed for the treatment of persistent or recurrent otitis media (infection and/or inflammation of the middle ear). Placement of the tube helps to ventilate the middle ear and enables the administration of topical antibiotics to treat the infection.
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. A Phase 3 trial in Ménière's disease patients is underway in the United States with a second trial expected to be initiated in the EU during the first quarter of 2016. 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, Otonomy's expectations regarding the timing of the OTO-104 Phase 3 clinical trial for Ménière's disease in the EU. 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-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 Current Report on Form 8-K filed with the Securities and Exchange Commission (the "SEC") on January 5, 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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