Amid opioid epidemic, FDA clears powerful painkiller


Despite concerns about a new opioid that is reportedly 1,000 times more powerful than morphine, FDA recently approved the new painkiller.

head shot RobertBolash.


Despite concerns about a new opioid that is reportedly 1,000 times more powerful than morphine, FDA recently approved the new painkiller.

However, sublingual sufentanyl (Dsuvia, AcelRx Pharmaceuticals) will not be available in retail pharmacies, said FDA Commissioner Scott Gottlieb, MD, in a statement. Instead, Dsuvia will be restricted to “certified medically supervised healthcare settings, an important step to help prevent misuse and abuse of Dsuvia,” Gottlieb said.

The Department of Defense worked closely with AcelRx to develop the medication, which is suited for “special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible,” Gottlieb said. “This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield.”

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While some individuals and organizations have criticized FDA’s approval of the drug, saying that it could compound the opioid addiction epidemic in the United States, some pain doctors are supporting the approval.

“Sublingual sufentanyl is a niche drug which has potential to improve the treatment of pain for a very small subset of patients. It satisfies an unmet clinical need and offers the opportunity to improve care for a small subgroup of patients who require treatment of acute pain in in the absence of an intravenous line, and those who are unable to tolerate an oral tablet,” Robert Bolash, MD, a pain management specialist at Cleveland Clinic, told FormularyWatch.

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Limiting the drug to exclusive use in healthcare settings or to treat battlefield injuries means it will not be available in retail pharmacies, and patients will not be permitted to have supplies at home in their medicine cabinets, Bolash added.

Bolash expects sublingual sufentayl to be used in hospital emergency departments almost exclusively. “After stabilizing these patients with acute pain, I anticipate that physicians will transition these patients to another pain treatment strategy,” Bolash said.

Dsuvia, a 30 mcg sufentanil tablet in a single-dose, pre-filled applicator for under the tongue (sublingual) administration by a healthcare professional only in certified medically supervised settings, is expected to be available in early 2019.

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