AcelRx Announces FDA Acceptance of NDA for DSUVIA

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings, today announced the acceptance of its New Drug Application (NDA) resubmission for DSUVIA™ by the U.S. Food and Drug Administration (FDA). The FDA considers the DSUVIA NDA resubmission a complete class 2 response to their October 2017 action letter. Therefore, the FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date of November 3, 2018.

"The acceptance of the DSUVIA NDA resubmission is yet another important milestone achieved by the Company this year," stated Vince Angotti, Chief Executive Officer of AcelRx. "We are one step closer to potentially delivering a new, non-invasive treatment option for the management of moderate-to-severe acute pain for adult patients in medically supervised settings. We believe DSUVIA, if approved, also has the opportunity to help U.S. hospitals manage through the intravenous opioid shortage1 they are currently experiencing in their facilities," continued Angotti

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