Flexion Therapeutics, Inc. (Nasdaq:FLXN) will present data from
three recent studies at the Osteoarthritis Research Society
International (OARSI) World Congress taking place May 2-5, 2019 in
Toronto, Canada.
“As a company focused on advancing innovative, local therapies
for the treatment of osteoarthritis (OA), the OARSI World Congress
provides us with a vital opportunity to engage in dialog with
leading academic researchers and garner new insights into this
chronic and painful condition,” said Michael Clayman, M.D.,
President and Chief Executive Officer of Flexion. “In particular,
we are proud to sponsor an important luncheon symposium, which aims
to foster critical discussions about the management of the patient
with OA knee pain, including the use of corticosteroids.”
Flexion data presented at the 2019 OARSI World Congress
includes the following:
Repeat Administration of Triamcinolone Acetonide
Extended-Release Affords Consistent, Clinically Relevant
Improvements in Pain: Results from a Phase 3b, Single-Arm,
Open-Label Study (Poster 732)
- Repeat administration of ZILRETTA® (triamcinolone acetonide
extended-release injectable suspension) tailored to patient
symptoms was generally safe and well-tolerated, had no deleterious
effect on cartilage or joint structure per x-ray, and resulted in
substantial improvements in OA symptoms after both injections;
and
- More than 60% of patients demonstrated a substantial analgesic
response with ≥50% improvement from baseline in WOMAC-A (pain),
WOMAC-B (stiffness), WOMAC-C (function), or KOOS-QoL score after
both the first and second injections of ZILRETTA.1,2
Safety and Systemic Exposure of Triamcinolone Acetonide
Following Intra-Articular Injection of Triamcinolone Acetonide
Extended-Release or Standard Triamcinolone in Patients with Hip
Osteoarthritis (Poster 731)
- ZILRETTA was generally safe and well-tolerated, and there were
no serious adverse events (AEs) or AEs leading to treatment
discontinuation;
- No study drug related AEs occurred in the ZILRETTA treatment
group.
- The PK profile of ZILRETTA observed in the hip was consistent
with previous PK studies in the knee showing some systemic
absorption and a plateau in plasma triamcinolone acetonide (TA)
concentration through Hour 24, followed by gradual systemic
elimination; and
- ZILRETTA injection into the hip resulted in lower peak plasma
levels and reduced systemic exposure relative to triamcinolone
acetonide crystalline suspension, a pattern similarly observed in
knee OA.
Dose-Dependent Chondroprotective Effects of
Triamcinolone Acetonide on Inflamed and Injured Cartilage Using an
In Vitro Model (Poster 230)
- In an in vitro model, the administration of pro-inflammatory
cytokines and/or mechanical injury to cartilage explants resulted
in a reduction of cartilage matrix biosynthesis and an increase in
cartilage matrix breakdown; and
- The administration of TA in inflamed and/or injured cartilage
tissue had protective effects, such as restoration of cartilage
matrix biosynthesis and prevention of cartilage matrix breakdown,
and no detrimental effects were observed at any dose in inflamed or
injured cartilage.
- The study was led by Professor Alan Grodzinsky, Sc.D.,
Director of the Center for Biomedical Engineering at the
Massachusetts Institute of Technology.
Flexion will also sponsor a lunchtime satellite symposium
entitled, “Considerations in the Chronic Management of
Osteoarthritis” today at 11:30 a.m. ET in the Grand East Ballroom.
The seminar will be led by Philip Conaghan, MBBS, Ph.D., FRACP,
FRCP, Professor of Musculoskeletal Medicine and Director of the
Leeds Institute of Rheumatic and Musculoskeletal Medicine at the
University of Leeds and Andrew Spitzer, MD, Co-Director, Joint
Replacement Program, Cedars-Sinai Orthopaedic Center.
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
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, 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; 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 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 Annual Report on
Form 10-K for the year ended December 31, 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.
References
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.
2. The KOOS (Knee Injury and Osteoarthritis Outcome Score) QoL
(Quality of Life) subscale Assesses patients' perceptions about
their treated knee and associated problems related to quality of
life.
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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