- Flexion Therapeutics Inc FLXN expanded the Phase 1b trial of FX301 in patients undergoing bunionectomy.
- Related: Flexion Therapeutics To Start Testing FX301 For Post-Op Pain In Patients After Musculoskeletal Surgery.
- FX301 is a formulation of a locally administered NaV1.7 inhibitor (funapide) which aims to provide at least three to five days of post-operative pain relief while preserving motor function.
- The Company's decision to advance FX301 into the expansion cohort following a review of safety data from an independent Safety Monitoring Committee.
- The single ascending dose stage of the Phase 1b trial was designed to evaluate the safety and tolerability of four dosing cohorts of 12 patients each.
- In the expansion cohort, an additional 36 patients will be enrolled to further assess the safety, tolerability, systemic exposure, and efficacy of FX301 as a single-injection analgesic nerve block adjacent to the sciatic nerve of the popliteal fossa.
- Data from the trial, including the expansion cohort, is anticipated by the end of 2020.
- Price Action: FLXN shares are up 12.0% at $5.96 during the market session on the last check Wednesday.
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