Flexion Therapeutics Enrolls First Patients in Phase 2 Trial of ZILRETTA® (triamcinolone acetonide extended-release injectab...
December 17 2019 - 7:30AM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the
first three patients were enrolled in a clinical trial to evaluate
the efficacy of ZILRETTA (triamcinolone acetonide extended-release
injectable suspension) in patients with either shoulder
osteoarthritis (OA) or adhesive capsulitis (AC), also known as
frozen shoulder. The Phase 2 double-blind, placebo-controlled,
study is expected to enroll up to 250 patients – approximately 135
with shoulder OA and 115 with shoulder AC.
“Shoulder OA and AC are both associated with pain and limited
range of motion which can significantly compromise a person’s
function and quality of life,” said Michael Clayman, M.D.,
President and Chief Executive Officer of Flexion. “ZILRETTA may
offer these patients an important non-surgical alternative that
could provide substantial and durable pain relief.”
The Phase 2 trial, known as the RANGE study, will separate
cohorts of patients by their diagnosis of shoulder OA or AC into
two parallel groups. Patients in each cohort will be randomized
(1:1) to either a single intra-articular injection of ZILRETTA or
normal saline. The primary endpoint for both cohorts of the trial
is the magnitude of pain relief versus placebo as measured by the
overall change in daily shoulder pain with movement score from
baseline to 8 weeks post injection. Patients in each cohort will be
stratified by baseline pain scores. Shoulder AC patients will be
further stratified by pain duration since onset and will also
utilize a home exercise program during the study.
Each participant will be evaluated for 24 weeks following
injection. The trial is expected to complete in the first half of
2021.
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 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 Shoulder Osteoarthritis & Adhesive
CapsulitisOsteoarthritis (OA), also known as degenerative
joint disease, affects more than 30 million adults living in the
United States and accounts for more than $185 billion in annual
expenditures. It is estimated that more than 30% of the population
over the age of 60 have symptomatic shoulder OA.¹ Adhesive
capsulitis (AC) is a long lasting, painful shoulder condition
commonly known as “frozen shoulder,” with patients experiencing
significant loss of range of motion. The average age of onset in
patients is 55 years of age, with AC being more common in females
and people with diabetes mellitus.²
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 people with musculoskeletal conditions, beginning with
osteoarthritis, the most common form of arthritis. Flexion is
building a portfolio of non-opioid therapeutics, with the goal of
making a meaningful difference in the lives of patients. The
Company's core values are focus, ingenuity, tenacity, transparency
and fun. Visit flexiontherapeutics.com.
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;
expected timing and scope of clinical trials; 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 inherent in
clinical development and the regulatory approval process, including
the risk of delays in clinical trials and that future clinical
results may not be consistent with prior results; risks related to
the market and market conditions; 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 September 30,
2019 filed with the SEC on November 7, 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
-
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3556427/
- https://www.ncbi.nlm.nih.gov/books/NBK532955/
Contacts:
Scott Young Vice President, Corporate Communications &
Investor Relations Flexion Therapeutics, Inc. T: 781-305-7194
syoung@flexiontherapeutics.com
Julie Downs Senior Manager, Corporate Communications &
Investor Relations Flexion Therapeutics, Inc. T: 781-305-7137
jdowns@flexiontherapeutics.com
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