The U.S. Food and Drug Administration (FDA) cleared Flexion Therapeutics’ Investigational New Drug (IND) application for FX301, a locally administered NaV1.7 inhibitor for post-operative pain. The clearance came after the FDA reviewed preclinical data that was developed by Flexion Therapeutics, as well as clinical data from previous clinical trials. Michael Clayman, MD, President and Chief Executive Officer of Flexion Therapeutics, said, “The IND clearance represents a key milestone for Flexion as we continue to advance our pipeline of important product candidates aimed at alleviating pain and improving outcomes for millions of people confronting musculoskeletal conditions along their continuum of care.”

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