AcelRx resubmits New Drug Application for DSUVIA

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," said 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 Europe this 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."

DSUVIA (sufentanil sublingual tablet, 30 mcg) is designed to treat moderate-to-severe acute pain and dosing errors associated with IV administration via its non-invasive single-dose applicator (SDA) in medically supervised settings. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. In Europe, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of DZUVEO.

Register as Visitor to CPhI China 2018!