Healthcare Industry News: Ipsen
News Release - October 5, 2015
Otonomy Receives FDA Clearance of Investigational New Drug Application for Tinnitus Product Candidate, OTO-311SAN DIEGO, Oct. 5, 2015 -- (Healthcare Sales & Marketing Network) -- Otonomy, Inc. (OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that the FDA has cleared the company's Investigational New Drug application (IND) for tinnitus product candidate OTO-311, a sustained-exposure formulation of the N-Methyl-D-Aspartate (NMDA) receptor antagonist, gacyclidine. The IND clearance enables Otonomy to initiate a Phase 1 dose escalation clinical safety trial of OTO-311 in normal healthy volunteers. OTO-311 will be given as a single unilateral intratympanic injection and subjects will be observed for four weeks following dosing.
Tinnitus is the medical term for hearing noise when there is no outside source of the sound. It is often described as a ringing in the ear but can also sound like roaring, clicking, hissing or buzzing. Tinnitus sufferers may have trouble hearing, concentrating, working and sleeping.
"Despite the debilitating nature of tinnitus that impacts millions of Americans, including a high proportion of military veterans, there is no cure and there are no FDA-approved drug treatments," said David A. Weber, Ph.D., president and chief executive officer of Otonomy. "Initiating this Phase 1 trial for OTO-311 before the end of 2015 meets our commitment to investors and also serves as an important first step towards our goal of bringing a single-dose intratympanic treatment to tinnitus sufferers."
The American Tinnitus Association reports that approximately 16 million patients in the United States have tinnitus symptoms severe enough to seek medical attention, and about two million patients cannot function on a normal day-to-day basis. Furthermore, the United States Department of Defense reports that tinnitus accounts for the most prevalent service-connected disability among veterans and that the costs of service-related tinnitus are estimated to exceed $2 billion. While the most common cause of tinnitus is exposure to loud noise, a number of other factors can be involved including heart or blood vessel problems, hormonal changes in women, ear and sinus infections, certain medications and thyroid problems. People with severe tinnitus may have trouble hearing, working and sleeping. At this time, there is no cure for tinnitus and there are no FDA-approved drugs for treating this debilitating condition.
OTO-311 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. Clinical studies, including pilot studies conducted with gacyclidine, support the use of NMDA receptor antagonists as potential treatments for tinnitus. In 2013, Otonomy acquired certain assets and rights to intellectual property related to the use of gacyclidine for the treatment of tinnitus from an affiliate of NeuroSystec Corporation, a company founded by serial entrepreneur Alfred Mann. In 2014, Otonomy entered into an exclusive license agreement with Ipsen (Euronext:IPN) (IPSEY) that enables Otonomy to utilize Ipsen's clinical and non-clinical gacyclidine data to support worldwide development and regulatory filings for OTO-311. The clinical data are from several Phase 1 and Phase 2 trials conducted by Ipsen in more than 300 patients who received treatment with systemic gacyclidine as a potential neuroprotectant in various neurologic trauma indications. OTO-311 utilizes Otonomy's proprietary drug delivery technology to achieve sustained exposure of gacyclidine in the inner ear from a single intratympanic (IT) injection.
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(TM) 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 completed a Phase 2b clinical trial in 154 patients with Meniere's disease. Based on these results, Otonomy intends to initiate two parallel Phase 3 trials for OTO-104 in Meniere'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 initiation, timing and design of Otonomy's Phase 1 clinical trial with OTO-311, the initiation, timing and design of Otonomy's Phase 3 clinical trials with OTO-104 and the timing of the launch of AuriPro(TM). 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.
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