Flexion Therapeutics Announces Podium Presentation of FX301 Preclinical Data at Virtual ANESTHESIOLOGY 2020 Meeting
October 05 2020 - 9:00AM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced the podium
presentation of preclinical efficacy and pharmacokinetic (PK) data
for FX301, its locally administered peripheral nerve block
candidate for control of post-operative pain at the virtual
ANESTHESIOLOGY 2020 meeting. This is an encore presentation of data
that were previously presented at the 2020 Regional Anesthesiology
and Acute Pain Medicine (ASRA) and International Anesthesia
Research Society (IARS) annual meetings. The podium presentation
“Selective Pharmacology of a NaV1.7 Antagonist Hydrogel in a Pig
Model of Nerve Block” is scheduled for 11:00 a.m. ET on Monday,
October 5, 2020.
“These preclinical data showing that FX301 provided a sustained
analgesic effect without motor impairment in a surgical pain model
are particularly exciting as they highlight the potential of FX301
to address a significant unmet need in post-operative pain
management,” said Scott Kelley, M.D., Chief Medical Officer of
Flexion. “We are thrilled to share these findings in a podium
presentation at the largest annual anesthesiology educational event
and look forward to discussing the data with anesthesiologists from
around the world.”
Highlights from the study include:
- FX301 provided both greater analgesic effect from 12 through 72
hours and a longer duration of effect through 72 hours compared to
liposomal bupivacaine or placebo;
- Treatment with FX301 did not significantly affect total walking
distance in animals at 2 and 24 hours post-injection; animals
treated with liposomal bupivacaine experienced a significant
reduction in total walking distance compared with baseline at 2 and
24 hours post-injection; and
- Systemic plasma profile of funapide, the active ingredient in
FX301, remained relatively flat throughout the study, indicative of
controlled drug release from the thermosensitive gel formulation,
while high local concentrations of funapide were observed at the
site of administration at 72 hours.
Flexion remains on track to file the Investigational New Drug
(IND) application and initiate clinical trials in 2021.
About FX301 FX301 is a locally administered
NaV1.7 inhibitor product candidate, known as funapide, formulated
for extended release in a thermosensitive hydrogel. The initial
development of FX301 is intended to support administration as a
peripheral nerve block for control of post-operative pain. Flexion
believes FX301 has the potential to provide effective pain relief
for three to seven days while preserving motor function and
anticipates initiating clinical trials in 2021.
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 people 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 regulatory and clinical developments and timelines; and
the potential therapeutic and other benefits of FX301, 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, the fact
that the impacts and expected duration of the COVID-19 pandemic are
uncertain and rapidly changing; the risk that additional
preclinical and other data may not support initiation of clinical
trials; the risk that we may not be able to maintain and enforce
our intellectual property, 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 Quarterly Report on Form 10-Q for the quarter ended June 30,
2020 filed with the SEC on August 5, 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
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