Flexion Therapeutics Announces Extended FDA Review of Supplemental New Drug Application for ZILRETTA®
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the
U.S. Food and Drug Administration (FDA) has informed the
company it needs additional time to complete the review of the
supplemental New Drug Application (sNDA) for ZILRETTA
(triamcinolone acetonide extended-release injectable suspension).
The anticipated Prescription Drug User Fee Act (PDUFA) action date
was today, October 14, 2019.
Although the FDA did not provide a new action date, the FDA
informed the company that the review is expected to be completed in
the coming weeks. The FDA has not asked for any additional clinical
data and the company has provided the FDA with all information
requested to date.
In December 2018, the company filed the sNDA seeking to revise
the ZILRETTA product label based on results from an open-label
Phase 3b clinical trial which evaluated repeat administration of
ZILRETTA in patients with osteoarthritis knee pain. The
findings from that trial were published in the peer-reviewed
journal Rheumatology & Therapy in February of this year.
Indication and Select Important Safety Information for
Indication: ZILRETTA is indicated as an
intra-articular injection for the management of osteoarthritis pain
of the knee. It is not intended for repeat administration.
Contraindication: ZILRETTA is contraindicated
in patients who are hypersensitive to triamcinolone acetonide,
corticosteroids or any components of the product.
Warnings and Precautions:
- Intra-articular Use Only: ZILRETTA has not
been evaluated and should not be administered by epidural,
intrathecal, intravenous, intraocular, intramuscular, intradermal,
or subcutaneous routes. ZILRETTA should not be considered safe for
epidural or intrathecal administration.
- Serious Neurologic Adverse Reactions with Epidural and
Intrathecal Administration: Serious neurologic events have
been reported following epidural or intrathecal corticosteroid
administration. Corticosteroids are not approved for this use.
- Hypersensitivity reactions: Serious reactions
have been reported with triamcinolone acetonide injection.
Institute appropriate care if an anaphylactic reaction occurs.
- Joint infection and damage: A marked increase
in joint pain, joint swelling, restricted motion, fever and malaise
may suggest septic arthritis. If this occurs, conduct appropriate
evaluation and if confirmed, institute appropriate antimicrobial
Adverse Reactions: The most commonly reported
adverse reactions (incidence ≥1%) in clinical studies included
sinusitis, cough, and contusions.
Please see ZilrettaLabel.com for full Prescribing
About ZILRETTA On October 6, 2017, ZILRETTA was
approved by the U.S. FDA as the first and only extended-release
intra-articular therapy for patients confronting
osteoarthritis-related knee pain. ZILRETTA employs proprietary
microsphere technology combining triamcinolone acetonide — a
commonly administered, short-acting corticosteroid — with a poly
lactic-co-glycolic acid (PLGA) matrix to provide extended pain
relief. The pivotal Phase 3 trial on which the approval of ZILRETTA
was based showed that ZILRETTA significantly reduced knee pain for
12 weeks, with some people experiencing pain relief through Week
16. Learn more at https://zilrettapro.com/.
About Osteoarthritis (OA) of the Knee OA, also
known as degenerative joint disease, affects more than 30 million
adults living in the U.S. and accounts for more than $185 billion
in annual expenditures. In 2016, more than 15 million Americans
were diagnosed with OA of the knee and the average age of
physician-diagnosed knee OA has fallen by 16 years, from 72 in
the 1990s to 56 in the 2010s. The prevalence of OA is expected to
continue to increase as a result of aging, obesity and sports
injuries. Each year, approximately five million OA patients receive
either an immediate-release corticosteroid or hyaluronic acid
intra-articular injection to manage their knee pain.
About Flexion Therapeutics Flexion Therapeutics
(Nasdaq:FLXN) is a biopharmaceutical company focused on the
development and commercialization of novel, local therapies for the
treatment of patients with musculoskeletal conditions, beginning
with osteoarthritis, a type of degenerative arthritis. The
company's core values are focus, ingenuity, tenacity, transparency
and fun. For the past three years, Flexion has been named one of
the Best Places to Work by the Boston Business Journal, and
Flexion was also recognized as a Top Place to Work in Massachusetts
by The Boston Globe in 2017 and 2018.
Forward-Looking Statements This release
contains forward-looking statements that are based on the current
expectations and beliefs of Flexion. Statements in this press
release regarding matters that are not historical facts, including,
but not limited to, statements relating to the future of Flexion;
the timing of the FDA’s review of the ZILRETTA sNDA; and expected
increases in the rate of individuals with OA of the knee, are
forward-looking statements. These forward-looking statements are
based on management's expectations and assumptions as of the date
of this press release and are subject to numerous risks and
uncertainties, which could cause actual results to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include, without limitation, the risk
that the FDA’s review of the sNDA takes longer than expected or
that the sNDA is not approved or results in changes to the ZILRETTA
label that are different than our expectations; whether any changes
to the ZILRETTA label will impact physicians’ willingness to
prescribe ZILRETTA; risks associated with commercializing new
pharmaceutical products in the United States; the risk that we may
not be able to successfully maintain an effective sales force or
product supply to commercialize ZILRETTA; competition from
alternative therapies; the risk that we may not be able to maintain
and enforce our intellectual property, including intellectual
property related to ZILRETTA; the risk that ZILRETTA may not be
successfully commercialized, including as a result of limitations
in ZILRETTA's label and package insert information; risks regarding
our ability to obtain adequate reimbursement from payers for
ZILRETTA; risks related to the manufacture and distribution of
ZILRETTA, including our reliance on sole sources of supply and
distribution; risks related to key employees, markets, economic
conditions, health care reform, prices and reimbursement rates; the
risk that we may use our capital resources in ways that we do not
currently expect; and other risks and uncertainties described in
our filings with the Securities and Exchange Commission (SEC),
including under the heading "Risk Factors" in our Quarterly Report
on Form 10-Q for the quarter ended June 30, 2019 filed with the SEC
on August 6, 2019 and subsequent filings with the SEC. The
forward-looking statements in this press release speak only as of
the date of this press release, and we undertake no obligation to
update or revise any of the statements. We caution investors not to
place considerable reliance on the forward-looking statements
contained in this press release.
Scott YoungVice President, Corporate Communications &
Investor RelationsT: email@example.com
Julie Downs Senior Manager, Corporate Communications Flexion
Therapeutics, Inc. T: 781-305-7137
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