Flexion Therapeutics Announces Expansion of Phase 1b Trial Investigating FX301 for the Management of Post-Operative Pain
- Initial findings from proof-of-concept trial in patients undergoing bunionectomy support expansion of the study to include 36 additional patients
- Data from the trial, including the expansion cohort, anticipated by year-end
“We are pleased that the initial findings from the four cohorts of the dose ranging data support the expansion of the trial in a selected dose,” said Michael Clayman, MD, President and Chief Executive Officer of Flexion Therapeutics. “We are excited to see the trial advance and look forward to sharing the results by the end of this year.”
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 (9 active:3 placebo). In the expansion cohort, an additional 36 patients will be randomized (1:1) to receive either FX301 at the selected dose (130 mg/low volume) or placebo 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.
FX301 is an investigational locally administered NaV1.7 inhibitor known as funapide, formulated for extended release in a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral analgesic nerve block for control of post-operative pain. Flexion believes FX301 has the potential to provide effective pain relief for at least three to five days while preserving motor function.
This press 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; timing and plans with respect to the Phase 1b clinical trial of FX301; 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 we may not be able to maintain and enforce our intellectual property, including intellectual property related to FX301; risks related to clinical trials, including potential delays, safety issues or negative results; the fact that initial clinical results may not be predictive of final results from a trial or results from future trials; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended
Source: Flexion Therapeutics, Inc.