FDA Draft Guidance on Development of Local Anesthetics with Prolonged Effect

The U.S. Food & Drug Administration (FDA) recently announced draft guidance for industry on the Development of Local Anesthetic Drug Products with Prolonged Duration of Effect.  Guidance recommendations “are intended to assist developers in generating the data necessary to support different indications and labeling claims for these drugs.”  Local anesthetic drug products have been used for pain relief following surgical procedures, but many are only effective for several hours.  “This guidance focuses on local anesthetic drug products that prolong the duration to a period of days,” and “is part of FDA’s efforts to reduce or eliminate the use of opioid analgesic drug products.”  To ensure agency consideration, comments should be submitted by June 14, 2023.  For more information, see the FDA draft guidance. [88 Fed. Reg. 16,265 (March 16, 2023)]