Flexion Therapeutics Presents New Data Evaluating Repeat Administration of ZILRETTA® (triamcinolone acetonide extended-relea...
July 15 2019 - 6:30AM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced impressive
new data from a post-hoc subgroup analysis of the open-label Phase
3b repeat administration trial of ZILRETTA (triamcinolone acetonide
extended-release injectable suspension) in patients with
osteoarthritis (OA) knee pain. The new findings were presented at
the American Orthopaedic Society Sports Medicine (AOSSM) conference
in Boston.
An exploratory analysis evaluating the efficacy of initial and
repeat administration of ZILRETTA in patients with symptomatic knee
OA ranging in radiographic severity from Kellgren-Lawrence (KL)
Grades 2 to 4 indicated that ZILRETTA consistently reduced OA knee
pain for 12 weeks after each injection, regardless of KL Grade.
Deryk Jones, M.D., Section Head of Sports Medicine and Cartilage
Restoration at the Ochsner Sports Medicine Institute presented
these data during a podium presentation entitled, “Expanding the
Potential of Nonoperative Therapies in Advanced Knee
Osteoarthritis: Treatment Response to Repeat Administration
Triamcinolone Acetonide Extended-Release is Similar Across KL
Grades 2-4” (Paper 93) on Sunday, July 14 at AOSSM.
“These findings add to the growing body of data for ZILRETTA and
highlight the important role it can play in helping patients manage
recurrent OA knee pain,” said Michael Clayman, M.D., President and
Chief Executive Officer of Flexion. “It is particularly gratifying
to see data indicating that ZILRETTA appeared to reliably reduce
knee pain in patients with KL Grade 4, the most radiographically
severe form of OA, representing a new patient group not previously
studied in our clinical trials.”
The analysis looked at 179 patients with OA knee pain who
received two injections of ZILRETTA, 56 (31.3%) of whom had KL
Grade 2, 68 (38.0%) had KL Grade 3, and 55 (30.7%) had KL Grade 4.
The key findings from the analysis include:
- Median times to second injection were 16.1 weeks for KL Grade
2, 16.9 weeks for KL Grade 3, and 17.1 weeks for KL Grade 4;
- >80% of patients were considered moderate responders (≥30%
reduction in pain) and ≥65% of patients were considered substantial
responders (≥50% reduction in pain) at Week 12 following each
injection;
- ZILRETTA appeared to reliably reduce knee OA pain with similar
improvements observed after each injection across all KL Grade
subgroups;
- Mean baseline WOMAC-A1 (pain) score was 2.15 across all KL
groups;
- At Week 12, mean WOMAC-A scores were 1.24 and 1.20 (KL Grade
2), 1.37 each (KL Grade 3), and 1.34 and 1.36 (KL Grade 4) for the
initial and second injection, respectively;
- Prior to injection, >77% of KL Grade 4 patients reported
moderate to severe pain, and following initial and repeat ZILRETTA
injections 92.5% and 82.4% of these patients, respectively,
reported no to mild pain at the earliest timepoint measured (Week
4);
- 63.0% and 60.0% of KL Grade 4 patients reported no to mild pain
at Week 12 following initial and repeat ZILRETTA injections,
respectively; and
- The incidence of treatment emergent adverse events (AEs) were
similar across all KL Grades and the most commonly reported
AEs were consistent with those reported in previous clinical
studies of ZILRETTA. Importantly, there were no indications of
chondrolysis, osteonecrosis, subchondral insufficiency fractures,
or clinically significant subchondral bone changes in any
subgroup.
An encore presentation of these data will be held on Thursday,
July 18 at the Southern Orthopaedic Association annual meeting.
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 three years, Flexion
has been named one of the Best Places to Work by the Boston
Business Journal, and Flexion was also recognized as a Top
Place to Work in Massachusetts by The Boston
Globe in 2017 and 2018.
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 Quarterly Report
on Form 10-Q for the quarter ended March 31, 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.
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.
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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