AcelRx Pharmaceuticals announced the resubmission of the New Drug Application (NDA) for DSUVIA with the U.S. Food and Drug Administration (FDA). AcelRx anticipates that the FDA will acknowledge acceptance of the NDA within 30 calendar days of the resubmission date. AcelRx expects a six-month review by the FDA with a projected PDUFA (Prescription Drug User Fee Act) date in the fourth quarter of 2018.
DSUVIA (sufentanil sublingual tablet, 30 mcg), known as DZUVEO™ in Europe, has a proposed indication for the management of moderate-to-severe acute pain in medically supervised settings, in adult patients. A positive opinion from the Committee for Medicinal Products for Human Use (CHMP) was recently issued recommending approval to the European Medicines Agency (EMA) for DZUVEO. A potential marketing authorization from EMA is expected in the third quarter of 2018.
“The resubmission of the DSUVIA NDA is an important milestone for the Company, and is our third key milestone achieved in the second quarter,” stated Vince Angotti, Chief Executive Officer of AcelRx. “This NDA resubmission follows the successful completion of the Human Factors study and the recent receipt of a positive opinion from CHMP for DZUVEO, and it keeps us on the path towards regulatory approvals for DSUVIA in the U.S. and for DZUVEO in Europethis year. Importantly, we believe DSUVIA has the potential, if approved, to provide a non-invasive option for moderate-to-severe acute pain and help U.S. hospitals manage through the intravenous opioid shortage1 they are experiencing in their facilities today,” continued Angotti.