Otonomy Successfully Completes Open-Label Clinical Trial for OTIPRIO® in Patients with History of Otitis Media Requiring Ty...
September 15 2016 - 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 the successful completion of an open-label Phase 3b
clinical trial that evaluated OTIPRIO® (ciprofloxacin otic
suspension) in 501 pediatric patients with a history of otitis
media requiring tympanostomy tube placement (TTP) surgery. The
Phase 3b trial was designed primarily to evaluate OTIPRIO in a
broader pediatric patient population than the previous Phase 3
trials by including patients undergoing common concurrent surgeries
and patients without bilateral effusion on the day of surgery. The
study also collected patient insurance information to evaluate
differences in outcomes for patients with Medicaid versus
commercial insurance, and assessed caregiver burden via a
questionnaire.
Summary results of the Phase 3b OTIPRIO trial are as
follows:
- The incidence of post-operative otorrhea was lower in patients
without bilateral effusion and also lower in patients undergoing a
concurrent adenoidectomy when compared to patients with bilateral
effusion and those undergoing TTP surgery alone, respectively.
- The incidence of otorrhea was similar for patients covered by
commercial insurance and Medicaid over the eight-week follow-up
period.
- The incidence of otorrhea reported through Day 15 was
comparable to the proportion of patients with treatment failure due
to otorrhea through Day 15 in the OTIPRIO treated groups of the
Phase 3 trials.
- OTIPRIO was well tolerated and the adverse event profile was
generally comparable to the previous Phase 3 trials.
- The caregiver survey indicated increased discomfort, lack of
confidence, and degree of non-compliance when ear drops were
required.
Full results from the trial will be presented at an upcoming
medical conference.
“This study provides important information regarding the use of
OTIPRIO in a patient population that reflects real-world clinical
practice and further supports the utility of OTIPRIO administered
as a single intraoperative dose by the physician,” said David A.
Weber, Ph.D., president and CEO of Otonomy. “Furthermore, the
benefit of assured compliance with OTIPRIO is highlighted by the
increased caregiver burden associated with patients who required
antibiotic ear drops, as well as by the similar outcomes measured
regardless of the patient's insurance status. This last point is
particularly noteworthy given the well-documented observation in
other conditions, such as pediatric asthma, that medication
adherence is lower and clinical outcomes are generally worse in the
Medicaid patient population."
The open-label Phase 3b clinical trial enrolled a total of 501
pediatric patients at multiple centers throughout the United
States. Patients received a single administration of OTIPRIO in
each ear during TTP surgery. The clinical activity of OTIPRIO was
measured through assessment of the presence of otorrhea, or
drainage from the tube. Safety was assessed through adverse event
reporting and otoscopic examinations over a two-month follow-up
period. This trial also assessed caregiver burden associated with
multi-dose, multi-day antibiotic ear drops in the subset of study
patients who required ear drops in the post-operative follow-up
period.
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, 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. Two Phase 3 trials in Ménière's
disease patients are underway, with results expected during the
second half of 2017. 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, the timing of results for the two OTO-104 Phase 3
clinical trials in Ménière's disease. 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-104 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 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; 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 Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission (the "SEC") on August 4, 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.
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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