The opioid uproar: FDA response

By Dr Nicola Davies

Approval by the US Food and Drug Administration of a highly potent opioid has garnered national attention and criticism from physicians, politicians, and others concerned about the increasing numbers of Americans dying from opioid overdoses, notes Dr Nicola Davies in her latest exclusive blog for The Pharma Letter

On November 2, 2018, the FDA announced its approval of Dsuvia, a sublingual tablet form of sufentanil, an opioid analgesic which has been used for intravenous and epidural anesthesia and analgesia for over 30 years.1 According to its manufacturer, AcelRx Pharmaceuticals (Nasdaq: ACRX), Dsuvia will be packaged in single-dose, pre-filled applicators, and only administered by healthcare professionals in certified medically supervised settings.2 Dsuvia, which was previously approved by the European Medicines Agency in July under the brand name Dzuveo, is five to 10 times stronger than the opioid drug fentanyl, and 500 to 1000 times more powerful than morphine.