Otonomy Announces FDA Acceptance of AuriPro(TM) New Drug Application
April 28 2015 - 7:00AM
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical
company focused on the development and commercialization of
innovative therapeutics for diseases and disorders of the inner and
middle ear, today announced that its New Drug Application (NDA) for
the approval of AuriProTM as a treatment of middle ear effusion in
pediatric patients undergoing tympanostomy tube placement (TTP)
surgery has been accepted for filing by the U.S. Food and Drug
Administration (FDA). The acceptance of the NDA indicates the
application is sufficiently complete to permit a substantive review
by the FDA.
"The FDA's acceptance of our NDA filing brings us one step
closer to the potential approval and U.S. commercial launch of
AuriPro, which is on track to be the first product marketed for the
treatment of middle ear effusion during TTP surgery," said Dave
Weber, Ph.D., president and CEO of Otonomy. "In addition, based on
pre-NDA communications, we do not believe that the FDA will convene
an advisory committee meeting for AuriPro prior to its
approval."
The NDA submission is supported by data from two identical
randomized, prospective, double-blind, sham-controlled Phase 3
clinical trials with a combined total of 532 pediatric patients. In
both trials, AuriPro achieved the primary efficacy endpoint of
reducing the incidence of treatment failures with statistical
significance (p<0.001) and was well tolerated.
About AuriPro
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 is currently reviewing Otonomy'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.
About Otonomy
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 middle and
inner ear following a single intratympanic injection. 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 a New Drug Application for AuriPro in this indication
is currently under FDA review. OTO-104 is a steroid that is in the
first of two pivotal clinical studies for the treatment of patients
with Ménière's disease. 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, 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. 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 18, 2015, 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.
CONTACT: Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Vice President
619.849.5377
heidi@canalecomm.com
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com
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