FDA Offers Advice on NDAs for Postoperative Local Anesthetics
Sponsors developing long-acting local postoperative anesthetics should consider including novel, clinically meaningful endpoints in their trial design, the FDA has said in new draft guidance.
The guidance reflects proposed advice for sponsors who plan to submit a new drug application (NDA), whether the compound is a new entity or an approved one seeking a new indication.
While the traditional safety and efficacy endpoints are still necessary, novel endpoints go beyond the basics of anesthetic effect and duration, providing additional insight into a drug’s short- and long-term impact.
Such endpoints might include reduction in hospitalization or rehospitalization, emergency department visits, death caused by opioid abuse, and improvements in the ability to resume work, school, or other productive activities.
The FDA “recognizes that evaluating these outcomes could require larger trials than those usually conducted for marketing approval,” the guidance notes.
March 17, 2023
https://www.fdanews.com/
The guidance reflects proposed advice for sponsors who plan to submit a new drug application (NDA), whether the compound is a new entity or an approved one seeking a new indication.
While the traditional safety and efficacy endpoints are still necessary, novel endpoints go beyond the basics of anesthetic effect and duration, providing additional insight into a drug’s short- and long-term impact.
Such endpoints might include reduction in hospitalization or rehospitalization, emergency department visits, death caused by opioid abuse, and improvements in the ability to resume work, school, or other productive activities.
The FDA “recognizes that evaluating these outcomes could require larger trials than those usually conducted for marketing approval,” the guidance notes.
March 17, 2023
https://www.fdanews.com/
