Otonomy Announces FDA Approval of OTIPRIO(R) for Acute Otitis Externa
March 02 2018 - 11:55AM
Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company
dedicated to the development of innovative therapeutics for
otology, today announced that the U.S. Food and Drug Administration
(FDA) has approved OTIPRIO (ciprofloxacin otic suspension) 6% for
the treatment of acute otitis externa (AOE) in patients 6 months of
age and older due to Pseudomonas aeruginosa and Staphylococcus
aureus. OTIPRIO is the first single-dose antibacterial approved by
the FDA for treating AOE.
"This approval is an important milestone for the OTIPRIO program
because it significantly expands the product's commercial potential
to include approximately 4 million episodes of AOE per year in the
United States, and broadens the target physician population beyond
otolaryngologists to pediatricians and primary care physicians who
treat the vast majority of AOE cases," said David A. Weber, Ph.D.,
president and CEO of Otonomy. “This indication also provides an
entry point for OTIPRIO use in the office setting where the
single-dose treatment can be administered by a physician or
healthcare professional and then billed using an existing J Code.
We look forward to incorporating AOE into our ongoing commercial
partnering and divestiture discussions."
About Acute Otitis Externa
Acute otitis externa (AOE), also known as swimmer’s ear, is a
common condition involving infection and inflammation of the
external ear canal typically caused by bacterial infection.
According to market data, there are approximately 4 million
episodes of AOE each year in the United States. Symptoms include
itchiness, redness, swelling, pain and pus draining from the
infected ear. Topical antibiotics are considered the standard of
care treatment for AOE with the typical regimen of ear drops
requiring several administrations to the affected ear each day for
up to 10 days.
About OTIPRIO
OTIPRIO is a sterile, preservative-free, otic suspension of 6%
ciprofloxacin administered as a single-dose by a healthcare
professional. The thermosensitive suspension exists as a liquid at
or below room temperature and gels when warmed.
For bilateral otitis media with effusion, OTIPRIO is
administered during ear tube surgery as a single 0.1 mL (6 mg)
intratympanic administration into each affected ear, following
suctioning of the middle ear effusion. 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).
For AOE, OTIPRIO is administered as a single 0.2 mL (12 mg)
administration to the external ear canal of each affected ear. In a
single Phase 3 trial, OTIPRIO demonstrated statistically
significant clinical response defined as the complete absence of
signs and symptoms of AOE (i.e., tenderness, erythema, edema, and
otorrhea) compared to sham (p-value < 0.001).
Approved Indications for OTIPRIO
OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone
antibacterial indicated for
- The treatment of pediatric patients 6 months of age and older
with bilateral otitis media with effusion undergoing tympanostomy
tube placement and
- The treatment of acute otitis externa in patients 6 months of
age and older due to Pseudomonas aeruginosa and Staphylococcus
aureus.
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 - Bilateral otitis media with effusion
clinical trials: Adverse reactions (incidence at least 3%)
with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability
(5% vs 3%), and rhinorrhea (3% vs 2%). Acute otitis
externa clinical trial: Adverse reactions (incidence at
least 2%) with OTIPRIO vs sham were: ear pruritus (2% vs 2%),
headache (2% vs 1%), otitis media (2% vs 1%), and ear discomfort
(2% vs 0%).
Use in Specific Populations - Pediatric Use:
The safety and effectiveness of OTIPRIO in infants below six months
of age have not been established for the treatment of pediatric
patients with bilateral otitis media with effusion undergoing
tympanostomy tube placement and acute otitis externa.
Full prescribing information can be found at
www.OTIPRIO.com.
About Otonomy
Otonomy is a biopharmaceutical company dedicated to the
development of innovative therapeutics for otology. The company
pioneered the application of drug delivery technology to the ear in
order to develop products that achieve sustained drug exposure from
a single local administration. This approach is covered by a broad
patent estate and is being utilized to develop a pipeline of
products addressing important unmet medical needs including
Ménière’s disease, hearing loss, and 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 the future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to, statements by Otonomy’s president and CEO.
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 regulatory
success and advancement of its product candidates; 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; Otonomy's dependence on third parties for the manufacture
of its product candidates; Otonomy's dependence on a small number
of suppliers for raw materials; Otonomy's ability to protect its
intellectual property related to 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 November 8, 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 InquiriesCanale
CommunicationsHeidi Chokeir, Ph.D.Senior Vice
President619.849.5377heidi@canalecomm.com
Investor InquiriesWestwicke PartnersRobert H. UhlManaging
Director858.356.5932robert.uhl@westwicke.com
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