AcelRx Pharmaceuticals Inc. said the U.S. Food and Drug Administration rejected its new drug application for DSUVIA to treat moderate-to-severe acute pain.
AcelRx submitted the application in December 2016. In a complete response letter, the U.S. FDA requested additional data on at least 50 patients and certain labeling changes in usage directions.
The 2016 application was supported by results from the entire ARX-04 clinical program, including data from four trials that showed improvement in pain intensity within 15 to 30 minutes of dosage.
"We believe the recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA," AcelRX CEO Vincent Angotti said in a statement.