Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the
results from a post-hoc analysis of data from the pivotal Phase 3
trial of ZILRETTA (triamcinolone acetonide extended-release
injectable suspension) were published in Advances in Therapy. The
findings indicated that patients with unilateral osteoarthritis
(OA) knee pain experienced significant and durable pain relief with
a single intra-articular injection of ZILRETTA compared to
immediate-release triamcinolone acetonide in crystalline suspension
(TAcs), as measured by Average Daily Pain (ADP) intensity scores.
The analysis also indicated that ZILRETTA patients in this subgroup
experienced improvements on OA-specific measures of pain,
stiffness, function, and quality of life scores that lasted up to
six months.
The objective of the analysis was to characterize the primary
endpoint of the trial, change in ADP, within a subgroup of
randomized patients with unilateral OA knee pain. The analysis
showed that patients in this subgroup who were treated with
ZILRETTA experienced a profound magnitude of analgesic effect, with
ADP scores that were reduced by >60% at Week 3-17. These results
suggest that bilateral knee pain may have been a confounding factor
in the pivotal trial, which assessed the impact of ZILRETTA
treatment in only one knee.
The authors, led by Michael J. Langworthy, M.D., Department of
Orthopedics & Orthopedic Surgery, Southcoast Health Systems,
Dartmouth, MA and leading advisor on arthritic joint disease to the
U.S. military, conducted this additional analysis to gain a deeper
understanding of the potential benefit of ZILRETTA and apply these
crucial insights to members of the armed forces. OA of the knee
affects more than 15 million Americans, including active-duty
military personnel, who frequently experience a higher incidence of
unilateral OA, as a result of previous injury. Approximately 11,000
active-duty military personnel are diagnosed with OA each year, and
it is the leading cause of disability discharge due to the chronic
and painful nature of the disease.1,2
“Military service members and others working in physically
demanding professions often must modify their activity or change
roles as a result of persistent OA knee pain, thus highlighting a
large unmet medical need for active professionals,” said Dr.
Langworthy. “I believe the results of this subgroup analysis lend
even further support for ZILRETTA as an effective non-opioid
alternative for people suffering from painful knee OA.”
Key topline results from the post-hoc analysis of the Phase 3
study:
- A single intra-articular injection of ZILRETTA provided
significant improvement in pain at Week 12 compared with placebo
(P<0.0001) and TAcs (P<0.01) to patients with unilateral knee
OA, as measured by ADP-intensity scores;
- ZILRETTA provided participants with unilateral knee OA
improvements in WOMAC-A (pain), WOMAC-B (stiffness), WOMAC-C
(physical function), and quality of life scores (KOOS-QoL) at Weeks
4, 8, and 12 (measured through standardized, verified instruments;
P<0.05 for all instruments) compared with TAcs and up to six
months compared with placebo (P<0.05); 3,4
- Patients treated with ZILRETTA used less rescue medication for
pain compared with both the placebo and TAcs groups; and
- Adverse events (AEs) were similar in frequency across treatment
groups, with most AEs reported as mild or moderate and unrelated to
the study agent.
“We are pleased to have this post-hoc analysis published in a
peer-reviewed journal, as it further reinforces ZILRETTA as an
important and effective treatment option offering pain relief to
those suffering from OA of the knee,” said Michael Clayman,
M.D., President and Chief Executive Officer of Flexion. “This
analysis provides us with important insight into the significant
benefit ZILRETTA may confer when used to treat isolated knee pain,
where the impact is more easily discerned.”
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
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 market potential and potential benefits; 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; 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 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.
References
1. Cameron KL, Driban JB, Svoboda SJ. Osteoarthritis and the
tactical athlete: A systematic review. J Athl Train. 2016;
51(11).2. Cameron KL, Hsiao MS, Owens BD, Burks R, Svoboda SJ.
Incidence of physician-diagnosed osteoarthritis among active duty
United States military service members. Arthritis Rheum. 2011;
63(10): 2974-82.3. 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.4. 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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