Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced initial
findings from its ongoing Phase 3b, open-label study to evaluate
the repeat administration of ZILRETTATM (triamcinolone acetonide
extended-release injectable suspension) in patients with
osteoarthritis (OA) of the knee.
The data show that of the 205 evaluable patients enrolled in the
study, 95% (195/205) experienced clinical benefit by Week 12
following the initial injection of ZILRETTA, as determined by
self-assessment and with the agreement of their physician.
Furthermore, to date 90% (176/195) of eligible patients have
received a second dose of ZILRETTA between Weeks 12 and 24, with
three patients still pending repeat administration.
“These data are very encouraging and provide us with the first
glimpse of how ZILRETTA can perform in a real-world setting,” said
Michael Clayman, M.D., President and Chief Executive Officer of
Flexion. “In particular, we are pleased with the observation that
the vast majority of patients have experienced clinical benefit and
that so many of them elect to have a second injection."
The primary endpoint of the trial is overall safety and general
tolerability of repeat administration of ZILRETTA in patients with
symptomatic OA of the knee. Participants received an initial
intra-articular injection of ZILRETTA followed by evaluation at
Weeks 12, 16, 20 or 24 to determine their eligibility for a second
injection. Repeat administration occurred when, in the opinion of
the patient and physician, the patient benefited from and tolerated
the initial administration without safety concerns and was
clinically indicated to receive additional treatment.
Participants who receive repeat administration of ZILRETTA are
followed for a total of 52 weeks after the initial injection,
regardless of when the second injection is administered. At
specified times throughout the trial, participants undergo physical
examinations, knee assessments and X-rays. To date, ZILRETTA has
been well tolerated, no serious adverse events have been observed,
and the overall safety profile is similar to that observed in the
single injection pivotal Phase 3 trial. The full study results are
expected in the third quarter of 2018.
Indications 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
ZILRETTA is 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 over 12 weeks.
ZILRETTA received approval from the U.S. Food and Drug
Administration on October 6, 2017 and the company initiated the
full commercial launch on November 20, 2017.
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 specialty pharmaceutical
company focused on the development and commercialization of novel,
local therapies for the treatment of patients with musculoskeletal
conditions, beginning with OA, a type of degenerative arthritis.
The company's core values are focus, ingenuity, tenacity,
transparency and fun. Flexion was named one of the Boston
Business Journal's 2017 Best Places to Work and one of
the Top Places 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; the expected timing of
additional data from Flexion’s trial to evaluate the safety of
repeat administration of ZILRETTA in patients with OA of the knee;
expected increases in the prevalence of OA; 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
designing and conducting clinical trials; the fact that preliminary
results of ongoing clinical trials or results of past clinical
trials may not be predictive of ongoing or subsequent trials; our
reliance on third parties to manufacture and conduct clinical
trials of ZILRETTA; the risk that we may not be able to maintain
and enforce our intellectual property, including intellectual
property related to ZILRETTA; competition from alternative
therapies; risks related to key employees, markets, economic
conditions, health care reform, prices and reimbursement rates; 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, 2017 filed on November 6, 2017 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 YoungSr. Director, Corporate Communications & Investor
RelationsFlexion Therapeutics, Inc.T:
781-305-7194syoung@flexiontherapeutics.com
Julie DownsManager, Corporate CommunicationsFlexion
Therapeutics, Inc.T: 781-305-7137jdowns@flexiontherapeutics.com
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