Otonomy Announces Successful End-of-Phase 2 Review by FDA for OTIPRIO® in Acute Otitis Media with Tympanostomy Tubes
June 22 2017 - 7:30AM
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 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 pediatric
patients with acute otitis media with tympanostomy tubes (AOMT).
Based on this feedback, Otonomy plans to conduct a single, sham
controlled, Phase 3 trial enrolling approximately 200 pediatric
patients with AOMT to support approval of OTIPRIO for this
indication. The timing for initiation of this trial has not yet
been determined.
“We are pleased with the outcome of our End-of-Phase 2
communication with the FDA including their acceptance of a single
Phase 3 trial to support the registration of OTIPRIO for the
treatment of AOMT,” said David A. Weber, Ph.D., president and CEO
of Otonomy. “This feedback is consistent with our previous
discussions regarding registration requirements for OTIPRIO in
acute otitis externa (AOE) for which we recently submitted a
supplemental New Drug Application (sNDA). We believe that, if
approved for these indications, AOMT and AOE will more than double
the U.S. market opportunity for OTIPRIO, and that OTIPRIO’s
single-dose, physician-administered profile is distinct from the
current standard of care which requires multi-dose, multi-day
administration of ear drops.”
In October 2016, Otonomy announced the successful completion of
a Phase 2 clinical trial that evaluated a single administration of
OTIPRIO for the treatment of pediatric patients with AOMT. The
one-month, prospective, randomized, sham-controlled, blinded Phase
2 clinical trial enrolled 95 pediatric patients with unilateral or
bilateral AOMT at 12 centers in the United States. The trial
demonstrated that both OTIPRIO doses evaluated, 6 mg (0.1 mL) and
12 mg (0.2 mL), were well-tolerated and achieved higher and
statistically significant (p<0.05) clinical cure rates over sham
(no treatment).
About Acute Otitis Media with Tympanostomy
Tubes
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) and can remain in
place for a year or more. During this time, recurrent ear
infections are common totaling approximately 900,000 cases of acute
otitis media with tympanostomy tubes (AOMT) per year in the United
States. Antibiotic ear drops are considered the standard of care
treatment for AOMT with the typical regimen requiring several
administrations each day for 7 days.
About OTIPRIO
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 Otonomy
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, an sNDA
has been submitted to the FDA for acute otitis externa (AOE) and a
successful Phase 2 trial has been completed in patients with acute
otitis media with tympanostomy tubes (AOMT). OTIVIDEX™ (formerly
OTO-104) is a steroid in development for the treatment of Ménière's
disease and other balance and hearing disorders. Two Phase 3 trials
in Ménière's disease patients are ongoing, AVERTS-1 in the United
States and AVERTS-2 in Europe, with AVERTS-1 results expected in
the third quarter of 2017 and AVERTS-2 results expected by the end
of 2017. In addition, a Phase 2 trial of OTIVIDEX is underway in
patients at risk for cisplatin-induced hearing loss. OTO-311 is an
NMDA receptor antagonist for the treatment of tinnitus that has
completed a Phase 1 clinical safety trial with a Phase 2 trial
expected to be initiated in the second half of 2017. A fourth
program targeting sensorineural hearing loss including age-related
hearing loss is in preclinical development. 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 the future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to, the timing of Phase 3 results for OTIVIDEX and the
timing of a Phase 2 clinical trial for OTO-311. 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 OTIVIDEX and OTO-311, and
label expansion indications for OTIPRIO; 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 nonclinical 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 nonclinical studies and clinical trials; the timing and
outcome of hospital pharmacy and therapeutics reviews and other
facility reviews; the impact of coverage and reimbursement
decisions by third-party payors on the pricing and market
acceptance of OTIPRIO; 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-Q filed with the Securities and Exchange
Commission (the "SEC") on May 4, 2017, 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.
Contacts:
Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Senior 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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