Posted by Michael Wonder on 12 Oct 2017
AcelRx Pharmaceuticals receives complete response letter from the FDA for Dsuvia NDA
12 October 2017 - AcelRx Pharmaceuticals today announced that it received a complete response letter from the U.S FDA regarding its new drug application for Dsuvia (sufentanil 30 mcg sublingual tablets).
The letter states that the FDA determined it cannot approve the NDA in its present form and provides recommendations needed for resubmission. The two primary recommendations within the letter are: first, while the safety database was suitable in number of patients, the collection of additional data was requested on at least 50 patients to assess the safety of Dsuvia dosed at the maximum amount described in the proposed labelling; second, to ensure proper administration of the tablet with the single-dose applicator, the FDA recommended certain changes to the Directions for Use to address use-related errors, including dropped tablets, to be validated through a human factors study.
