Data from Pharmawand - Curated by EPG Health - Date added 13 October 2017
AcelRx Pharmaceuticals has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Dsuvia (sufentanil sublingual tablet), 30 mcg. The CRL 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 CRL 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.
Comment: AcelRx will request a meeting with the FDA to discuss the topics covered in the CRL, and confirm plans to move towards resubmission of the DSUVIA NDA. AcelRx ended the third quarter with an estimated $67.9 million in cash and we will provide further financial updates on our third quarter earnings call.