Flexion Therapeutics Announces FDA Approval of sNDA to Revise ZILRETTA® (triamcinolone acetonide extended-release injectable...
December 26 2019 - 04:15PM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the
U.S. Food and Drug Administration (FDA) has approved a
supplemental New Drug Application (sNDA) to update the product
label for ZILRETTA (triamcinolone acetonide extended-release
injectable suspension) for the treatment of osteoarthritis (OA)
knee pain.
Key elements of the label update include:
- Removal of language which stated that ZILRETTA was “not
intended for repeat administration.” The updated label states that
the “efficacy and safety of repeat administration of ZILRETTA have
not been demonstrated.”
- Inclusion of a study description and safety data from the
single-arm, open-label Phase 3 repeat administration trial.
- Removal of a misleading statement describing a single secondary
exploratory endpoint in the original Phase 3 pivotal trial which
compared ZILRETTA to immediate release triamcinolone acetonide
crystalline suspension.
- Inclusion of nonclinical toxicology data from previously
submitted single and repeat administration studies in non-diseased
animals.
“We are very pleased with the new product label as it achieves
our primary goal of removing unclear language pertaining to repeat
administration, which we believe was potentially confusing to
patients, physicians and payers alike,” said Michael Clayman, M.D.,
President and Chief Executive Officer of Flexion. “In addition, we
are gratified by the inclusion of safety data from our repeat
administration trial and the removal of the inappropriate
comparator statement. We believe the updated label supports our
goal of seeing ZILRETTA become the leading intra-articular therapy
for managing OA knee pain.”
Added John Richmond, M.D., Medical Director for Network
Development, New England Baptist Hospital, “As both a clinician and
a ZILRETTA patient, I have firsthand experience with the
significant magnitude and duration of pain relief it can provide to
people confronting knee OA. ZILRETTA is an invaluable non-opioid
option for managing chronic OA knee pain, and it is encouraging to
see a new product label that better informs clinical decision
making.”
Conference CallFlexion's management will host a
conference call at 8:00 a.m. on Friday, December 27, 2019 to
discuss the approval. The dial-in number for the conference call is
(855) 770-0022 for U.S. participants and (908) 982-4677 for
international participants, with Conference ID # 5887398. A live
webcast of the conference call can also be accessed through the
"Investors" tab on the Flexion Therapeutics website
at www.flexiontherapeutics.com. A webcast replay will be
available online after the call.
Indication and Select Important Safety Information for
ZILRETTA
Indication: ZILRETTA is indicated as an
intra-articular injection for the management of osteoarthritis pain
of the knee.
Limitation of Use: The efficacy and safety of repeat
administration of ZILRETTA have not been demonstrated.
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
treatment.
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
Information.
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.
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, the most common form of arthritis. The
company's core values are focus, ingenuity, tenacity, transparency
and fun. Visit flexiontherapeutics.com.
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;
ZILRETTA's market potential and potential benefits; the future
impact of the changes to ZILRETTA’s label; 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, whether the changes to
the ZILRETTA label impact physicians’ willingness to prescribe, and
payers’ willingness to reimburse, 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 September 30,
2019 filed with the SEC on November 7, 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.
Contacts:
Scott YoungVice President, Corporate Communications &
Investor RelationsFlexion Therapeutics, Inc.T:
781-305-7194syoung@flexiontherapeutics.com
Julie Downs Senior Manager, Corporate Communications &
Investor Relations Flexion Therapeutics, Inc. T: 781-305-7137
jdowns@flexiontherapeutics.com
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