Flexion Therapeutics Enrolls First Patient in Phase 2 Pharmacokinetics and Safety Study of ZILRETTA™ (triamcinolone acetoni...
December 07 2017 - 4:35PM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) announced today the
enrollment of the first patient in a clinical trial to evaluate the
pharmacokinetics (PK) and safety of concurrent injections of
ZILRETTA (triamcinolone acetonide extended-release injectable
suspension) in patients with bilateral osteoarthritis (OA) of the
knee. The randomized, open-label, Phase 2 study is expected to
enroll approximately 24 patients.
The safety and tolerability of a single injection
of ZILRETTA has been established through multiple Phase 2 and Phase
3 clinical trials focused on administration in one knee. ZILRETTA
received approval from the U.S. Food and Drug Administration on
October 6, 2017 for the management of OA knee pain and the company
initiated the full commercial launch on November 20, 2017.
“We know there are many patients who suffer from
bilateral knee OA pain, yet physicians are often reluctant to
administer an immediate-release steroid into both knees
concurrently due to concerns about systemic exposure,” said Michael
Clayman, M.D., President and Chief Executive Officer of Flexion.
“The data from this study are expected to provide insight into
ZILRETTA’s potential to further demonstrate lower plasma
concentrations from two injections compared with traditional
immediate-release steroids.”
The study will compare plasma PK profiles after
concurrent injections of ZILRETTA versus immediate-release
triamcinolone acetonide in crystalline suspension (TAcs). Patients
will be randomized and treated with bilateral injections of either
ZILRETTA (total dose of 64 mg) or TAcs (total dose of 80 mg). Each
patient will be evaluated for six weeks following injection.
Flexion expects to report top-line results of the study in the
first half 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
FDA-approved 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.
About 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 TherapeuticsFlexion 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 StatementsStatements 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 size, scope and results of Flexion’s trial to
evaluate the PK and safety of concurrent injections of ZILRETTA in
patients with bilateral OA of the knee; expected increases in the
prevalence of OA; and the potential therapeutic and other benefits
of ZILRETTA for patients with bilateral 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 designing and conducting clinical trials; the fact
that results of past clinical trials may not be predictive of
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 most recent Quarterly Report on
Form 10-Q 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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