Benzinga | Mar 1, 2021 12:58PM EST

Flexion Therapeutics To Start Testing FX301 For Post-Op Pain In Patients After Musculoskeletal Surgery

The FDA signed off Flexion Therapeutics Inc's (NASDAQ: FLXN) Phase 1b proof of concept trial evaluating FX301 administered as a popliteal fossa block (a commonly used nerve block in the foot and ankle-related surgeries) in patients undergoing bunionectomy.

* FX301 combines NaV1.7 inhibitor (funapide) with thermosensitive hydrogel to facilitate administration as a peripheral analgesic nerve block.

* The study will start in the first half of this year, with topline data expected in late 2021.

* The company says that FX301 can potentially provide non-opioid pain relief for at least 3 to 5 days while preserving motor function following musculoskeletal surgery.

* Preclinical data demonstrated analgesic effect beginning at 1-hour post-dosing compared to placebo and significantly more significant analgesic effect than liposomal bupivacaine at 36 hours post-dosing.

* Price Action: FLXN shares are 1.4% higher at $11.25 in market trading hours on the last check Monday.