Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced an
independent evaluation of clinical data for ZILRETTA®
(triamcinolone acetonide extended-release injectable suspension),
conducted by Adis Drug Review, was published in the journal Drugs
(Vol 79 (4) pp 455–462). The evidence-based evaluation concluded
that ZILRETTA provided effective pain relief, while being generally
well-tolerated as demonstrated in clinical studies, and it expands
the treatment options for osteoarthritis (OA) knee pain.
Adis Drug Review provides an independent analysis of data on new
or established treatments, across all therapeutic areas, to
determine clinical potential. Their assessment of ZILRETTA included
data from six clinical trials conducted over the past seven years,
which evaluated 1,347 patients, 613 of whom were treated with
ZILRETTA.
“We believe this analysis provides a particularly important
resource, as it presents clinicians and payers with a comprehensive
view of ZILRETTA’s clinical trial data and the benefits it confers
to patients with OA knee pain,” said Michael Clayman, M.D.,
Flexion’s President and Chief Executive Officer.
The Adis Drug Evaluation found:
- Treatment with a single injection of ZILRETTA provided
significant pain relief in patients with OA knee pain relative to
placebo with respect to average daily pain (ADP) scoring in
clinical trials and provided a similar level of pain relief to that
of a single injection of triamcinolone acetonide crystalline
suspension (TAcs).
- In the Phase 3 trial, patients who received ZILRETTA reported
improvements in pain, stiffness, and physical function compared
with TAcs and placebo in pre-specified exploratory endpoints, which
utilized the OA-specific Western Ontario and McMaster Universities
Arthritis Index. Furthermore, they also reported improvements
compared with TAcs and placebo on the Knee Injury and OA Outcome
Score Quality of Life assessment.
- ZILRETTA had a similar tolerability profile to those seen with
TAcs and placebo. ZILRETTA was generally well-tolerated with most
adverse events (AEs) being of mild to moderate severity, and no
radiographic evidence of rapidly progressing OA was observed over
the 24-week study period in the Phase 3 trial.
- Patients with type 2 diabetes receiving ZILRETTA in the Phase 2
trial experienced a significantly smaller (p = 0.045) change in
blood glucose elevation compared with those receiving TAcs and a
negligible impact on their glycemic control.
- Results from the single-arm Phase 3b trial showed that the
tolerability of repeat administration of ZILRETTA was consistent
with that seen in the single administration Phase 3 trial. An
analysis of radiographs (X-rays) taken at baseline and Week 52
showed no evidence of deleterious effects on cartilage or other
aspects of joint structure with the repeat administration. Data
suggest that a repeat administration of ZILRETTA may be similarly
efficacious to an initial injection without further increasing the
risk for AEs.
- The most frequent AE in patients who received two injections of
ZILRETTA was arthralgia in any joint (joint pain without swelling),
including two treatment-related arthralgia cases after the first
injection and no treatment-related cases following the second
injection.
- Additional studies with ZILRETTA, including longer-term
evaluations, use in other joints, and head-to-head studies with
TAcs, may be valuable in establishing relative efficacy and
tolerability.
A randomized, double-blind, placebo-controlled Phase 3 trial
evaluating the safety and efficacy of ZILRETTA in patients with hip
OA is currently enrolling. The study is expected to complete in
2020.
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.
About the Adis Drug Review Program The Adis
Drug Review program, which includes Adis Drug Evaluations, Q&As
and Biosimilar Briefs, provides clinically relevant information on
the properties of new and established drugs, across all therapeutic
areas. Adis Drug Reviews are single-agent, narrative reviews,
written by the scientific editorial staff of Springer Nature and
independently peer reviewed by international experts. In
particular, Adis Drug Evaluations provide an independent analysis
of the pharmacological properties, clinical efficacy and
tolerability of an agent as well as evaluating new data to put
forth the group’s recommendation on the agent’s clinical potential
and appropriate place in therapy.
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 potential benefits; Flexion’s plans and expected timing
for clinical and regulatory milestones and activities; 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 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; potential delays in initiating or
completing clinical trials; 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; 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, 2018 filed with the SEC on February 28, 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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