www.fdanews.com/articles/186611-fda-accepts-clinical-research-plan-for-senzers-inhaler
FDA Accepts Clinical Research Plan for Senzer’s Inhaler
April 30, 2018
The FDA accepted an application for a clinical development study on Dronabinol inhalation using Senzer’s inhaler device, a breath-activated inhaler.
The approval means the clinical program will begin to explore vomiting and chemotherapy-induced nausea in adult cancer patients who had suboptimal reactions to conventional antiemetics.
The program aims to validate how a pharmaceutical version of Dronabinol, an FDA-approved cannabinoid being developed by Insys, can be delivered through Senzer’s inhaler device.