Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced results
from two analyses of the company’s recently-approved drug Zilretta™
(triamcinolone acetonide extended-release injectable suspension),
the first and only extended-release, intra-articular (IA) injection
for the management of osteoarthritis (OA) knee pain. The clinical
findings will be presented at the 2017 American College of
Rheumatology (ACR) Annual Meeting, taking place November 3-8 in San
Diego.
Zilretta is a non-opioid medicine that employs Flexion’s
proprietary microsphere technology. Zilretta was approved by the
U.S. Food and Drug Administration (FDA) on October 6, 2017 as an IA
injection for the management of OA pain of the knee. The approval
was based upon data from Flexion’s pivotal Phase 3 clinical trial,
a randomized, double-blind study, which enrolled 484 patients at 37
centers worldwide.
“The data presented at ACR further affirm the effectiveness of
Zilretta in providing extended relief of OA knee pain,” said
Michael Clayman, M.D., President and Chief Executive Officer of
Flexion. “The growing body of data surrounding Zilretta continues
to demonstrate the important role this product may play for the
millions of Americans suffering from this debilitating
disease.”
Clinical Data Presentations:
Title: Effectiveness of FX006 Intra-Articular Injection
in Patients with Knee Osteoarthritis who Present with and without
Clinical Inflammation at Baseline: A Pooled Analysis of Data from 3
Double-Blind, Randomized, Parallel-Group Clinical
TrialsPresentation: 934Date and
Time: Sunday, November 5, 2017; 4:30 PM - 6:00 PM
The investigators conducted a pooled subgroup analysis of three
double‐blind, randomized, placebo‐controlled Phase 2/3 trials of
patients with knee OA to compare the efficacy of Zilretta (FX006)
in patients with and without baseline inflammation as determined by
clinical assessment. Patients received a single IA injection of
Zilretta 32 mg or saline‐placebo. Average Daily Pain
(ADP)-intensity was assessed for 24 weeks and WOMAC pain (A),
stiffness (B) and physical function (C) were assessed at baseline
and Weeks 4, 8, 12, 16, 20 and 24.1 Of the 586 study patients, 349
or 60% of patients with knee OA had baseline inflammation.
Results showed that Zilretta provided sustained clinical
improvement in OA knee pain vs. saline-placebo. Furthermore, the
effect of Zilretta was generally enhanced more than two-fold in
patients with baseline inflammation versus those without
inflammation.
Title: Updating the Knee Osteoarthritis Intra-Articular
Corticosteroid Meta-Analysis with Two Large Trials of
Extended-Release Triamcinolone Acetonide (FX006) Versus
PlaceboPoster: 1200Date and
Time: Monday, November 6, 2017; 9:00 AM - 11:00 AM
To assess the clinical relevance of Zilretta (FX006), a recent
meta-analysis was updated to include data from two large,
randomized, placebo‐controlled Phase 2/3 trials of Zilretta in
patients with knee OA. In the studies, patients with OA of the knee
received a single IA injection of Zilretta 32 mg or saline‐placebo.
ADP was collected for 24 weeks and standardized mean difference was
computed for ADP-intensity at Weeks 2, 6, 12 (3 months) and 24 (6
months) post-treatment. The expanded meta-analysis appeared to
demonstrate that Zilretta provided greater pain relief through
three months compared with traditional IA corticosteroids, further
supporting the clinical relevance of Zilretta as beneficial for
treating OA knee pain.
Zilretta is now commercially available in the U.S. For more
information, visit www.zilretta.com or call
1-844-FLEXION.
Indication and Important Safety Information
Indication: ZILRETTA (triamcinolone acetonide
extended-release injectable suspension) is indicated as an
intra-articular injection for the management of osteoarthritis pain
of the knee.
Limitations of Use: ZILRETTA 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. Serious events have been
reported with epidural and intrathecal administration of
corticosteroids and none are approved for this use. ZILRETTA should
not be considered safe for epidural or intrathecal
administration.
- Hypersensitivity
Reactions: Rare instances of
anaphylaxis, including serious cases, have occurred in patients
with hypersensitivity to corticosteroids.
- Joint Infection
and Damage: A
marked increase in pain accompanied by local swelling, restriction
of joint motion, fever and malaise are suggestive of septic
arthritis. Examine joint fluid to exclude a septic process. If
diagnosis is confirmed, institute appropriate antimicrobial
therapy. Avoid injecting corticosteroids into a previously infected
or unstable joint. Intra-articular administration may result in
damage to joint tissues.
- Increased Risk
of Infections:
Infection with any pathogen in any location of the body may be
associated with corticosteroid use. Corticosteroids may increase
the susceptibility to new infection and decrease resistance and the
ability to localize infection.
- Alterations in
Endocrine
Function: Corticosteroids can
produce reversible hypothalamic-pituitary-adrenal axis suppression,
with potential for adrenal insufficiency after withdrawal of
treatment, which may persist for months. In situations of stress
during that period, institute corticosteroid replacement
therapy.
- Cardiovascular and
Renal Effects:
Corticosteroids can cause blood pressure elevation, salt and water
retention and increased potassium excretion. Monitor patients with
congestive heart failure, hypertension and renal insufficiency for
edema, weight gain and electrolyte imbalance. Dietary salt
restriction and potassium supplementation may be needed.
- Increased Intraocular
Pressure: Corticosteroid use may
be associated with increased intraocular pressure. Monitor patients
with elevated intraocular pressure for potential treatment
adjustment.
- Gastrointestinal
Perforation: Corticosteroid
administration may increase risk of gastrointestinal perforation in
patients with certain GI disorders and fresh intestinal
anastomoses. Avoid corticosteroids in these patients.
- Alterations in
Bone Density:
Corticosteroids decrease bone formation and increase bone
resorption. Special consideration should be given to patients with
or at increased risk of osteoporosis prior to treatment.
- Behavior and
Mood
Disturbances: Corticosteroids may
cause adverse psychiatric reactions. Prior to treatment, special
consideration should be given to patients with previous or current
emotional instability or psychiatric illness. Advise patients to
immediately report any behavior or mood disturbances.
Adverse
Reactions: The most commonly
reported adverse reactions (incidence ≥1%) in clinical studies
included sinusitis, cough and contusions.
Please see the full
Prescribing Information at
www.ZILRETTAlabel.com.
*The efficacy and safety of repeat administration of ZILRETTA
have not been evaluated.
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.
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 specialty pharmaceutical 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.
Forward-Looking StatementsStatements in this
press release regarding matters that are not historical facts,
including, but not limited to, statements relating to the future of
Flexion; timing for the expected commercial availability of
Zilretta; our plans to commercialize Zilretta and its 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 the process of launching a new pharmaceutical
product in the United States; 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; the risk that we may not be able to
successfully hire, train and maintain an effective sales force to
commercialize 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 payors 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; and
other risks and uncertainties described in our filings with the
Securities and Exchange Commission (SEC), including under the
heading "Risk Factors" in our most recent Annual Report on Form
10-K 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 YoungSr. Director, Corporate Communications & Investor
RelationsFlexion Therapeutics, Inc.T:
781-305-7194syoung@flexiontherapeutics.com
Julie DownsManager, Corporate Communications Flexion
Therapeutics, Inc.T: 781-305-7137jdowns@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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