Flexion Therapeutics Announces Publication of Pooled Analysis of Phase 2/3 Data on Use of Rescue Medication with ZILRETTA® (...
May 10 2019 - 7:30AM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that a
pooled analysis of data from three Phase 2/3 randomized clinical
trials on the use of rescue medications with ZILRETTA
(triamcinolone acetonide extended-release injectable suspension)
were published in Pain and Therapy. The analysis indicated that
rescue medication use was significantly lower following a single
injection of ZILRETTA, the first and only extended-release
intra-articular therapy for OA knee pain, in comparison to placebo
and TAcs.
In clinical trials that evaluate the efficacy of pain therapies,
rescue medications, such as acetaminophen, may generally be used by
patients to manage acute episodic pain when the primary treatment
is not providing sufficient relief. Measuring rescue medication use
can provide important information on the robustness of the overall
analgesic effect, as effective pain medications should reduce the
need for rescue medications and lower the cumulative exposure to
potentially harmful side effects.
“The fact that ZILRETTA reduced patients’ use of acetaminophen
speaks to the magnitude of analgesia that ZILRETTA can provide, and
its potential to also limit the need for rescue medications,
including addictive options, like opioids,” said Alan Kivitz, MD,
Altoona Center for Clinical Research.
Key topline results from the Phase 2/3 studies:
- The overall number of rescue medication tablets used per day
through Week 24 was significantly less for ZILRETTA compared to
saline-placebo (LSM difference, −0.43) and TAcs (–0.24); and
- The safety profile of ZILRETTA in this pooled analysis was
consistent with that of the pivotal Phase 3 trial.
“All too often, patients diagnosed with OA of the knee find
themselves in an endless cycle with brief periods of relief,
commonly followed by quick recurrence of pain,” said Michael
Clayman, M.D., President and Chief Executive Officer of Flexion.
“The publication of this analysis in a peer-reviewed journal
further supports the substantial relief that ZILRETTA can offer
patients coping with OA knee pain.”
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. 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
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. Learn more at www.zilretta.com.
About Osteoarthritis (OA) of the Knee OA, also
known as degenerative joint disease, affects more than 30 million
Americans 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, more than 15 million Americans are treated for
OA-related knee pain, and 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 two years, Flexion has been named one of the
Best Places to Work by the Boston Business Journal, and a Top
Place to Work in Massachusetts by The Boston Globe.
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; 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, risks
associated with developing and obtaining regulatory approval for
product candidates; the fact that results of past clinical trials
may not be predictive of subsequent trials; 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 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 March 31, 2019 filed with the
SEC on May 8, 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 DownsSenior Manager, Corporate Communications &
Investor RelationsFlexion Therapeutics, Inc.T:
781-305-7137jdowns@flexiontherapeutics.com
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