Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the
key results from the previously completed pivotal Phase 3 study
evaluating ZILRETTA (triamcinolone acetonide extended-release
injectable suspension) have been published in the print and online
edition of the Journal of Bone and Joint Surgery (Vol 100 (8)
pp 666 – 677). ZILRETTA was approved by the U.S. Food and Drug
Administration (FDA) on October 6, 2017, as an intra-articular (IA)
injection for the management of pain associated with osteoarthritis
(OA) of the knee.
The randomized, double-blind, placebo-controlled,
active-comparator Phase 3 trial enrolled 484 patients at 37 centers
worldwide. Patients were randomized to one of three treatment
groups (1:1:1) and received either a single IA injection of
ZILRETTA (32 mg), normal saline-placebo or triamcinolone acetonide
in crystalline suspension (TAcs) (40 mg). Data from this study
served as the foundation for ZILRETTA’s New Drug
Application and subsequent FDA approval.
“These data demonstrate ZILRETTA’s ability to provide rapid,
substantial and persistent pain relief in individuals with knee
OA,” said Michael Clayman, M.D., President and Chief Executive
Officer of Flexion. “The publication of these results in the
prestigious Journal of Bone and Joint Surgery helps advance the
dialogue within the medical and scientific communities about the
important role ZILRETTA can play in the treatment paradigm of OA
knee pain, presenting an important option for the millions of
Americans who confront this painful disease.”
The primary study objective was to assess the magnitude of pain
relief at 12 weeks in patients receiving ZILRETTA compared with
saline-placebo as measured by the weekly mean of the average daily
pain (ADP) score. Each patient was evaluated for efficacy and
safety during seven outpatient visits over 24 weeks after receiving
an injection.
Professor Philip Conaghan, M.D., Ph.D., lead study investigator
and Chair of Musculoskeletal Medicine at the University of Leeds
stated, “OA of the knee is a serious condition that is highly
prevalent globally, often leaves people in chronic pain and
presents a high economic burden to society. These data reflect the
clinical trial rigor necessary to guide the understanding of this
novel therapeutic option and represent an important milestone for
the OA scientific and clinical communities.”
Key findings and conclusions reported by the authors include
that ZILRETTA:
- Met its primary endpoint, demonstrating a highly statistically
significant (p<0.0001) reduction in ADP versus saline-placebo at
week 12, with durable pain relief in patients with moderate to
severe OA knee pain;-- Provided an approximately 50 percent
reduction in pain from baseline over weeks 1 through 12, a benefit
that extended through week 16.
- Was favored when compared with saline-placebo and TAcs at each
time point through 12 weeks on exploratory measures – WOMAC A1
(pain), WOMAC B (stiffness) and WOMAC C (function) and the Knee
Injury and Osteoarthritis Outcome Score (KOOS) quality of life
subscale;
- Demonstrated reduced rescue medicine consumption compared with
saline-placebo and TAcs (exploratory endpoint);
- Was superior to saline-placebo, but the difference between
ZILRETTA and TAcs as measured by ADP was not statistically
significant;
- Demonstrated an acceptable safety profile, with adverse events
being generally mild and occurring at similar frequencies across
treatment groups. The most common adverse events for ZILRETTA with
an incidence greater than 5 percent were joint pain, headache and
back pain. No drug-related serious adverse events were observed and
no patients treated with ZILRETTA discontinued the study due to a
treatment-related side effect.
“Many patients are prescribed opioids for the pain associated
with OA of the knee, which have shown only moderate success and are
often eclipsed by significant adverse effects including addiction
and withdrawal,” said John Richmond, M.D., Medical Director for
Network Development, New England Baptist Hospital. “The development
of non-opioid alternatives for patients with OA knee pain is
crucial for our society, and it is exciting to be able to offer
ZILRETTA in my clinical practice as a new treatment.”
Indication and Select Important Safety Information for
ZILRETTA (triamcinolone acetonide extended-release
injectable suspension)
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 ZILRETTA is the first and only
FDA-approved 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 over 12 weeks. ZILRETTA received approval from
the U.S. Food and Drug Administration on October 6, 2017 and the
company initiated the full commercial launch on November 20,
2017.
About Osteoarthritis (OA) of the Knee OA
is the most common joint disease, affecting more than 30 million
Americans and accounting 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 IOA 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 OA, a type of degenerative arthritis. The company's
core values are focus, ingenuity, tenacity, transparency and fun.
Flexion was named one of the Boston Business
Journal's 2017 Best Places to Work and one of the Top
Places 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; expected increases in the rate of
individuals with OA of the knee; and the potential therapeutic and
other benefits of ZILRETTA 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 commercializing new
pharmaceutical products; the fact that results of past clinical
trials may not be predictive of subsequent trials; our reliance on
third parties to manufacture and conduct clinical trials of
ZILRETTA; the risk that we may not be able to maintain and enforce
our intellectual property, including intellectual property related
to ZILRETTA; competition from alternative therapies; risks related
to key employees, markets, economic conditions, health care reform,
prices and reimbursement rates; and other risks and uncertainties
described in our filings with the Securities and Exchange
Commission (SEC), including under the heading "Risk Factors" in our
Annual Report on Form 10-K for the year ended December 31, 2017
filed with the SEC on March 8, 2018 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.
Corporate Contact:
Scott Young Vice President, Corporate Communications &
Investor Relations Flexion Therapeutics, Inc. T:
781-305-7194 syoung@flexiontherapeutics.com
Julie Downs Manager, Corporate Communications Flexion
Therapeutics, Inc. T:
781-305-7137 jdowns@flexiontherapeutics.com
1 WOMAC (Western Ontario and McMaster Universities Arthritis
Index) is a validated, widely used, proprietary set of standardized
questionnaires used by health professionals to evaluate the
condition of patients with osteoarthritis of the knee and hip,
including pain, stiffness and physical functioning of the
joints.
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