The US Food and Drug Administration (FDA) has issued draft guidance on the development of local anesthetic products with a prolonged duration of effect that can last for days.
The guidance, published on 16 March 2023, is part of a larger effort to reduce the use of opioid analgesic drugs, according to FDA. “Although different local anesthetic drug products have different pharmacokinetic (PK) profiles, in general their effects last a few hours. However, the increasing interest in reducing or eliminating the use of opioid analgesic drug products is leading to development of dosage forms of local anesthetic drug products that prolong the duration of action of the drug product to a period of days rather than hours,” the agency wrote.
The guidance focuses on the development of local anesthetic drug products that produce postoperative analgesia and which require a new drug application (NDA) under section 505(b) of the Federal Food, Drug, and Cosmetic Act…
