The U.S. FDA has approved AcelRx Pharmaceuticals’ Dsuvia sublingual tablet for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings.
The approval has met with large criticisms, as the U.S. opioid crisis reaches epidemic levels, however the FDA is confident that restrictions being placed on the distribution and use of the product are sufficient.
The California-based biotech points to a medical need. "As an anesthesiologist, I've seen the challenges that IV opioids pose to patients and providers, such as logistical delays in initiating IV lines, difficulty in accessing veins, and medication errors with injectable opioids. AcelRx was founded to develop a simple, effective, non-invasive analgesic option to enable healthcare professionals to rapidly manage their patients' acute pain,” said Dr. Pamela Palmer, AcelRx’s co-founder and CMO, in a press statement.
Dsuvia will not be available in retail pharmacies or for outpatient use and will only be distributed to health care settings certified in the Dsuvia Risk Evaluation and Mitigation Strategy (REMS) program following attestation by an authorized representative.
Dsuvia was approved for use in the EU this summer. This approval marks the first time the company has received authorization to market a drug in the United States.
Read the press release