FDA approves new, powerful drug amidst opioid crisis

FDA approves powerful opioid despite fears of more overdose deaths

The painkiller Dsuvia will be restricted to limited use only in health care settings, such as hospitals, surgery centers and emergency rooms, but critics worry the opioid will fuel an already grim opioid epidemic. The study demonstrated that patients receiving the drug experienced significantly greater pain reduction versus placebo over the first 12 hours post-treatment.

The drug is five to 10 times more potent than pharmaceutical fentanyl.

Supporters of the drug also argue that even though sufentanil is known to be very potent, the effective dose of Dsuvia is a tiny, premeasured 30 mcg. The most notable of these critics might actually be in-house: the chair of the FDA advisory committee, who also happens to be the chair for the consumer advocacy group Public Citizen.

In a statement, FDA Commissioner Scott Gottlieb M.D. explained that the drug could be of good use in cases where the patient may not be able to swallow properly, and how the Department of Defense worked closely with the sponsor in the development of the drug, particularly because of its need to treat soldiers in the battlefield.

Additionally, four Democratic senators had urged Gottlieb to deny approval on Dsuvia until Brown and other drug safety committee members could participate in the decision and vote, in a letter they sent last Wednesday. "This action is inconsistent with the charter of the agency", Brown said in a statement Friday. Alan says the concern around the drug is "valid given the potential for abuse".

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A 2016 survey conducted by the federal Substance Abuse and Mental Health Services Administration shows that narcotics are rarely stolen from doctor's offices, clinics, hospitals or pharmacies. The military wants to explore whether the pill can be used as a battlefield painkiller that is less cumbersome than liquid analgesics.

To that, however, anesthesiologist Dr. Pamela Palmer-who is also the co-founder of AcelRx-argues that "diversion" of Dsuvia is extremely low.

"The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds", he wrote.

"The FDA approval of Dsuvia is the culmination of almost 15 years of research to improve the standard of care for managing acute pain in medically supervised settings", Palmer said in a statement. It is the tablet version of an opioid that's now marketed for intravenous delivery, and was also approved in Europe just last July under the brand name Dzuveo.

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