Flexion Therapeutics Presents ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) Efficacy Data at th...
November 11 2019 - 7:30AM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced results
from a sensitivity analysis evaluating the treatment effects of a
single administration of ZILRETTA (triamcinolone acetonide
extended-release injectable suspension) in patients with
moderate-to-severe osteoarthritis (OA) pain on both the Average
Daily Pain (ADP) and WOMAC-A1 (pain) scales. The post-hoc analysis
of data from the pivotal Phase 3 trial indicated that in patients
who reported moderate-to-severe pain at baseline on the two
reporting instruments, ZILRETTA provided statistically significant
and clinically meaningful pain relief compared with
immediate-release triamcinolone acetonide in crystalline suspension
(TAcs) and placebo.
The findings suggest that pre-treatment concordance
across two pain assays may serve as an important patient
eligibility criterion in future clinical trials. The data was
presented in a poster session (Poster: 285) on November 8 at the
recent American Association of Hip and Knee Surgeons (AAHKS) Annual
Meeting. An encore presentation of these findings will be given at
the American College of Rheumatology Annual Meeting (Abstract:
1309) on Monday, November 11, 2019 from 9:00-11:00 a.m. ET.
“The results indicate that concordant pain
reporters may be better able to discern treatment effect. Our
analysis revealed that a number of study participants had elevated
baseline ADP scores compared to WOMAC-A pain scores prior to
treatment,” said Scott Kelley, M.D., Chief Medical Officer of
Flexion. “Baseline score inflation can occur when a minimum pain
level is required to meet the trial enrollment criteria and may
bias studies toward a reduced estimate of treatment effect. This
analysis suggests that the use of multiple assays may be an
important consideration in patient selection criteria as it may
provide a more accurate picture of patients’ baseline pain.”
Study participants received either a single
injection of ZILRETTA, TAcs or placebo. Patient-reported
ADP‐intensity, WOMAC-A scores, and rescue medication usage were
assessed throughout the study, and 60.3% (292/484) of patients with
knee OA (Kellgren-Lawrence Grade 2-3) reported moderate-to-severe
OA pain at baseline using both instruments (ADP ≥5 to ≤9 and
WOMAC-A ≥2).
In concordant pain reporters:
- ZILRETTA significantly (P<0.05) improved ADP scores compared
with TAcs (Weeks 5-19) and placebo (Weeks 1-20), and the proportion
of patients reporting no knee pain (ADP score=0) at Week 12 was
higher with ZILRETTA (~28%) compared with TAcs (~8%);
- ZILRETTA significantly (P<0.05) improved WOMAC-A scores at
Weeks 4, 8, and 12 (ZILRETTA vs TAcs) and Weeks 4, 8, 12 and 16
(ZILRETTA vs placebo);
- ZILRETTA significantly (P<0.05) reduced rescue medication
use from Weeks 2-20 (ZILRETTA vs TAcs) and Weeks 1-24 (ZILRETTA vs
placebo); and
- Baseline characteristics and adverse event profiles were
consistent with those of the overall Phase 3 population.
The results of this post hoc analysis may have
implications for study design and patient recruitment of future
trials evaluating efficacy of intra-articular interventions for OA
knee pain.
Indication and Select Important Safety
Information for ZILRETTA® (triamcinolone acetonide extended-release
injectable suspension)
Indication: ZILRETTA
(triamcinolone acetonide extended-release injectable suspension) 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 2017, approximately 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, approximately five million OA patients receive
either a corticosteroid (immediate-release or extended-release) 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, the most common form of
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 recognized as a Top Place to
Work in Massachusetts by The Boston Globe in 2017
and 2018. 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; potential implications of data analysis for future
clinical trial designs; 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 that future
clinical results will 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.
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
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.
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