Benzinga | Oct 5, 2020 09:06AM EDT

Flexion Therapeutics Announces Podium Presentation Of FX301 Preclinical Data At Virtual ANESTHESIOLOGY 2020 Meeting At 11:00 a.m. ET

* Previously presented preclinical findings show FX301 provided greater sustained, post-operative analgesic effect with no significant impairment in motor function compared to liposomal bupivacaine and placebo

BURLINGTON, Mass., Oct. 05, 2020 (GLOBE NEWSWIRE) -- 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," saidScott 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.