Otonomy Announces Publication of OTIPRIO™ Phase 3 Clinical Trial Results in JAMA Otolaryngology
March 18 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 publication of the positive results of the Phase 3
clinical trials of OTIPRIO™ (ciprofloxacin otic suspension) in JAMA
Otolaryngology – Head & Neck Surgery. The trial results are
from two identically designed, prospective, double-blind,
sham-controlled, multicenter Phase 3 randomized clinical trials of
OTIPRIO in a total of 532 pediatric patients undergoing
tympanostomy tube placement (TTP).
“These trials demonstrated the safety and efficacy of a single
administration of OTIPRIO in pediatric patients for the treatment
of bilateral middle ear effusion at the time of ear tube
placement,” said Eric A. Mair, M.D., of Charlotte, Eye, Ear, Nose,
& Throat Associates. “Administration of a single dose of
OTIPRIO by the ENT during the procedure provides treatment with
assured compliance.”
“I would like to sincerely thank the patients, their families
and the physicians who participated in the OTIPRIO clinical
trials,” said David A. Weber, Ph.D., president and CEO of Otonomy.
“We are extremely pleased that JAMA Otolaryngology – Head &
Neck Surgery has chosen to publish these data in their journal. The
commercial launch of OTIPRIO is now underway in the U.S. and the
publication of these results in a well-respected, peer reviewed
journal provides broad access for physicians to the Phase 3
clinical data.”
The two Phase 3 trials enrolled a total of 532 patients at
approximately 50 centers in the U.S. and Canada. Pediatric patients
with bilateral middle ear effusion on the day of surgery were
randomized to receive TTP alone or TTP with a single intraoperative
administration of OTIPRIO. The primary efficacy endpoint was
treatment failure defined as the presence of otorrhea, use of otic
or systemic antibiotics, loss to follow-up or missed visits through
Day 15. The cumulative proportion of treatment failures was 24.6%
in Trial 1 and 21.3% in Trial 2 in the OTIPRIO treatment groups,
compared to 44.8% in Trial 1 and 45.5% in Trial 2 in the TTP alone
groups, with p<0.001 for each trial. The most frequently
reported adverse events in both trials were nasopharyngitis,
irritability, and rhinorrhea. No drug-related serious adverse
events were seen. No evidence of increased tube occlusion and no
negative effect on results of audiometry, tympanometry, or otoscopy
were noted with OTIPRIO administration.
About OTIPRIO
OTIPRIO (ciprofloxacin otic suspension) 6% 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. 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 plans to initiate a Phase 3 trial for
OTO-104 in Ménière's disease in the EU during the first quarter of
2016. 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; 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 Annual Report on Form 10-K filed with the
Securities and Exchange Commission (the "SEC") on March 7, 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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