Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced the
publication of data from two new analyses of patients treated with
ZILRETTA (triamcinolone acetonide injectable suspension), including
an analysis of 305 patients in the Phase 3 and Phase 3b trials that
showed treatment with ZILRETTA resulted in no deleterious impact on
joint structure. A separate analysis indicated that patients
treated with ZILRETTA demonstrated greater mobility and walked more
steps per day following treatment. The findings were accepted as
abstracts at Osteoarthritis Research Society International (OARSI)
OARSI 2020 and published in the Osteoarthritis & Cartilage
journal.
“The results from the patient survey provide an important
reminder of the extraordinary toll knee OA takes on patients’
quality of life and underscore the need for effective disease
management,” said Michael Clayman, M.D., President and Chief
Executive Officer of Flexion. “To this end, these new analyses
further establish the potential for ZILRETTA to provide meaningful
and durable pain relief to these patients.”
Prospective Radiographic Analysis of the Effect of
Single and Repeat Administrations of Intra-Articular
Corticosteroids in Knee Osteoarthritis (Abstract 741)
An analysis of prospective radiographic data from the pivotal
Phase 3 and the Phase 3b repeat administration trials assessed the
effect of ZILRETTA and immediate-release triamcinolone acetonide in
crystalline suspension (TAcs) injections in patients with
symptomatic knee osteoarthritis (OA). Key findings show:
- No subchondral bone change, osteonecrosis, or radiographically
documented rapidly progressive OA was identified in the 305
patients treated with ZILRETTA; and
- In 450 patients with knee OA who were treated with single or
repeated doses of intra-articular corticosteroids there were no
signs of osteonecrosis or chondrolysis observed over 6-12 months,
and only one patient treated with TAcs showed evidence suggesting
subchondral insufficiency fracture.
Fitbit®-Derived Evidence of Enhanced
Mobility of Patients with Knee OA Treated with ZILRETTA: Results
from a Phase 3b, Single-Arm, Open-Label (Abstract 745)
An analysis of 208 patients enrolled in the ZILRETTA Phase 3b,
single-arm, open-label repeat administration study assessed the
clinical benefit of treatment based on patient mobility defined as
numbers of steps per day. The evaluation was conducted using a
Fitbit, worn at least seven days prior to the first injection on
Day 1 and through the end of Week 12 to measure step values. Key
findings show:
- Patients treated with ZILRETTA exhibited improvement in
mobility as shown by increases in weekly mean steps per day from
Weeks 1-3 and change from baseline in weekly mean steps per day
through Week 11;
- Patients treated with ZILRETTA exhibited a decrease in pain,
with mean changes from baseline in WOMAC-A (pain) scores of -1.4,
-1.2, and -0.8 at Weeks 4, 8, and 12, respectively; and1
- Greater change in step count from baseline was observed in
association with larger decreases in WOMAC pain scores.
A Thousand Patient Voices: Knowledge, Impact, and
Experiences of Living with OA of the Knee
(Abstract 735)
An online survey of 1,041 patients (age ≥40 years) with
physician diagnosed OAK was conducted by Harris Poll to examine
patient attitudes and understanding of OAK, the effect it has on
their overall health, limitations in function and social
participation caused by OAK, and treatment experiences. Key survey
findings include:
- Nearly all patients (95%) reported that OAK had a negative
impact on their quality of life;
- Most patients (88%) felt that OAK had forced them to give up or
negatively impacted one or more physical activities; particularly
exercise or sport activities (85%);
- Patients acknowledged social and emotional consequences of OAK:
31% noted their self-esteem worsened, 29% reported feeling confined
to their home, 24% noted feeling isolated from friends and family,
and 21% responded that OAK made it difficult for them to maintain
healthy relationships;
- Approximately 67% of patients indicated that they were
concerned about their health, and 37% reported that OAK made it
difficult for them to manage other health issues; and
- One third (33%) of survey respondents reported using opioids in
the past to manage OAK pain, and 73% of those continued opioid use
in the year before the survey.
These findings reveal opportunities for patient education about
self-management and other treatment approaches.
Encores of these abstracts were also accepted at the American
Medical Society for Sports Medicine annual meeting and published in
the Clinical Journal of Sport Medicine.
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.
Limitation of Use: The efficacy and safety of repeat
administration of ZILRETTA have not been demonstrated.
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.
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.
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 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
related to clinical trials, including potential delays, safety
issues or negative results; risks related to key employees,
markets, economic conditions, and health care reform; 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 filed with the SEC on March 12,
2020 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 Associate Director, 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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