Flexion Therapeutics Announces Full Commercial Launch and Nationwide Availability of ZILRETTA™ (triamcinolone acetonide ext...
November 20 2017 - 7:30AM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced the full
commercial launch of ZILRETTA™ (triamcinolone acetonide
extended-release injectable suspension), the company’s new therapy
for the management of pain associated with osteoarthritis (OA) of
the knee. On October 6, 2017, ZILRETTA was approved by the U.S.
Food and Drug Administration, and the product has been available on
a limited basis since October 23. Flexion has hired and trained
more than 100 field sales representatives, known as Musculoskeletal
Business Managers, who are now deployed across the country.
“We have assembled a remarkable team of
Musculoskeletal Business Managers, and last week they concluded
their training at the ZILRETTA national launch meeting,” said
Michael Clayman, M.D., President and Chief Executive Officer of
Flexion. “We have already begun the process of informing and
educating physicians about the important role ZILRETTA can play in
the management of OA knee pain. With its extended-release
microsphere formulation, we believe ZILRETTA holds the potential to
disrupt the current treatment paradigm, and we are thrilled that it
is now broadly available for the millions of Americans confronting
this relentless disease.”
OA is a progressive and incurable condition and the most common
form of arthritis. Its effects may range from intermittent
discomfort to the loss of function and severe chronic pain
associated with irreversible structural damage. ZILRETTA is the
first and only extended-release, intra-articular injection for OA
knee pain. It is a non-opioid medicine that employs Flexion's
proprietary microsphere technology to provide proven pain relief
over 12 weeks.
For more information about ZILRETTA,
visit www.ZILRETTA.com or call
1-844-FLEXION.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
www.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 Osteoarthritis (OA) of the KneeOA is the
most common joint disease, affecting more than 30 million Americans
and accounting 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 best places to work by both the Boston
Globe and the Boston Business Journal.
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; our plans to commercialize Zilretta and its market
potential; 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
associated with the process of commercializing Zilretta, including
the extent to which Zilretta is adopted by physicians and patients
and is reimbursed by third party payors; the fact that results of
past clinical trials may not be predictive of subsequent trials;
our reliance on third parties to manufacture and distribute
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; regulatory
developments and safety issues, including difficulties in
maintaining regulatory approvals to market Zilretta; 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 with the SEC on November 6, 2017. 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
Sr. Director, Corporate Communications & Investor
RelationsFlexion Therapeutics, Inc.T:
781-305-7194syoung@flexiontherapeutics.com
Julie DownsCorporate Communications ManagerT:
781-305-7137jdowns@flexiontherapeutics.com
Flexion Therapeutics (NASDAQ:FLXN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Flexion Therapeutics (NASDAQ:FLXN)
Historical Stock Chart
From Apr 2023 to Apr 2024