Drugs

Guide on Postoperative Nausea/Vomiting Drugs

FDA has released a draft guidance entitled “Postoperative Nausea and Vomiting: Developing Drugs for Prevention.” The document provides recommendations regarding the design of clinical trials for such drugs, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments. The agency notes that the guidance does not address the development of drugs for treating postoperative nausea and vomiting (PONV), nor does it cover developing preventive therapies for pediatric patients.

The guidance says sponsors developing drugs for preventing PONV should consider the following when selecting trial populations:

Participants should be scheduled to undergo an operative procedure in which general inhalational anesthesia will be provided.
Participants should have two or more established risk factors for developing PONV to help identify a treatment effect.

Additionally, to establish efficacy for a drug to prevent PONV, the guidance says sponsors should assess a primary efficacy endpoint of complete response, which should be defined as no vomiting and no use of rescue antiemetic medication in the 24 hours immediately following surgery. It also recommends a secondary endpoint of the absence of nausea that is defined as no nausea and no use of rescue antiemetic medication in the 24 hours immediately following surgery.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome