Flexion Therapeutics to Present Data on Zilretta™ (FX006) at PAINWeek 2017
September 07 2017 - 07:30AM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today will present results
from an analysis that found patients treated in clinical trials of
Zilretta™ (FX006), its lead candidate for the treatment of
osteoarthritis (OA) knee pain, had a statistically significantly
lower use of analgesic rescue medications following treatment
compared to placebo. The data will be presented in a poster session
(abstract #92) at PAINWeek 2017, the largest U.S. pain conference
for frontline clinicians.
A post hoc, pooled analysis of three Phase 2/3 double-blind,
randomized, placebo-controlled clinical trials was conducted with
586 patients suffering from OA of the knee. Patients received a
single, intra-articular (IA) injection of Zilretta (32 mgs) or
saline-placebo, and average daily pain (ADP) intensity was assessed
for a period of at least 12 weeks. Trial participants
received a rescue medication (acetaminophen/paracetamol 500 mg
tablets) at the beginning of the study. The patients’ consumption
of the rescue medication was monitored through a daily diary
reporting system, and pill counts were confirmed at the clinical
sites.
Rescue medications are commonly provided to patients in clinical
trials investigating analgesic therapies. Patients can use rescue
medicines to manage pain on an as-needed basis during the trial,
and their utilization can provide investigators with important
information about the overall analgesic effect of the therapy being
studied. The analysis showed that the use of rescue medication was
statistically significantly lower (p<0.05) with Zilretta
compared to saline-placebo at each of Weeks 1–12. At Week 12, the
mean number of daily rescue medication tablets taken was 0.86 for
Zilretta compared with 1.23 for saline-placebo, resulting in a
least-square-mean (LSM) difference of -0.37. These results support
the analgesic efficacy of Zilretta through 12 weeks post-IA
injection. The incidence of adverse and serious adverse events were
similar across the Zilretta and saline-placebo groups (51.9% vs
49.2%, and 3.1% vs 1.1%, respectively). No drug-related serious
adverse events were observed in these trials and adverse events
have typically been localized, mild and comparable to those
observed with saline-placebo.
"In clinical trials, Zilretta has demonstrated clinically
meaningful pain relief for patients with OA of the knee for at
least 12 weeks, and the reduced utilization of rescue medicines
observed in this analysis serves as another important indicator of
the robustness of Zilretta’s analgesic profile," said Michael
Clayman, M.D., President and Chief Executive Officer of Flexion.
“We believe that, pending regulatory approval, Zilretta has the
potential to bring meaningful pain relief to millions of Americans
who make up this large and growing patient population.”
About Osteoarthritis (OA) of the Knee OA is the
most common joint disease, affecting more than 30 million Americans
and accounting for more than $185 billion in annual expenditures.
In 2015, more than 14 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. OA
prevalence is expected to continue to increase as a result of
aging, obesity and sports injuries. Each year, more than five
million OA patients in the U.S. receive either an immediate-release
corticosteroid or hyaluronic acid intra-articular injection for
knee pain.
About ZilrettaZilretta is being investigated as
the first intra-articular, extended-release treatment for patients
with OA related knee pain. Zilretta employs proprietary microsphere
technology combining triamcinolone acetonide — a commonly
administered, short-acting corticosteroid — with a poly
lactic-co-glycolic acid matrix. In February 2017, the FDA accepted
the company's New Drug Application for Zilretta in OA of the knee.
Under the Prescription Drug User Fee Act, the agency has
established a user fee goal date of October 6, 2017.
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.
Forward-Looking Statements Statements in this
press release regarding matters that are not historical facts,
including, but not limited to, statements relating the potential
therapeutic and other benefits of Zilretta, potential regulatory
approval of Zilretta, and expectations regarding the prevalence of
OA 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 discovering, developing,
manufacturing and obtaining regulatory approval for drugs that are
safe and effective for use as human therapeutics; 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, which could delay or limit its future
development or regulatory approval; 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 or delays in obtaining regulatory approvals
to market Zilretta; Zilretta may not be successfully
commercialized, including as a result of the FDA's or other
regulatory authorities' decisions regarding labeling and other
matters that could affect its availability or commercial potential;
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 Annual Report on Form
10-K 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.
Corporate Contact:
Scott Young
Sr. Director, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7194
syoung@flexiontherapeutics.com
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