Published: Wed, November 07, 2018
Medical | By Johnnie Horton

FDA approves opioid painkiller 1,000 times stronger than morphin

FDA approves opioid painkiller 1,000 times stronger than morphin

Other news on opioids focuses on the FDA's armed hunt for counterfeit drugs and the continued threat of fentanyl and heroin.

In a highly controversial move, the Food and Drug Administration approved an especially powerful opioid painkiller despite criticism that the medicine could be a "danger" to public health.

News outlets have decried the approval and emphasized sufentanil's effects as "500 times more powerful than morphine;" however, Pamela Palmer, MD, PhD, chief medical officer of AcelRx Pharmaceuticals, which developed the drug, explained in an interview with Pharmacy Times' sister publication, MD Magazine, that these overstatements are misguided.

Dsuvia, made by AcelRx Pharmaceuticals Inc., is a tablet in a single-dose, prefilled applicator to be administered under the tongue by health care providers to patients in settings such as hospitals, surgical centers and emergency rooms, according to the company.

"The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain", he said.

One factor that weighed heavily in the Dsuvia decision is military interest in the drug, Gottlieb said in his statement. Most of that was the result of a record number of opioid-related deaths.

More: Drugs kill more Americans than guns, cars and AIDS.

The sublingual administration makes Dsuvia an option for patients with nothing by mouth (NPO) status and patients with hard IV access (obese, elderly, burn or needle-phobic patients), according to the statement.

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Gottlieb also points out in his statement that it can help in special circumstances in which a patient may not be able to swallow, adding that there could be potential uses on the battlefield.

"DSUVIA will not be available in retail pharmacies or for outpatient use".

Other restrictions, according to the FDA, include that it cannot be used for more than 72 hours and will have the same black-box warnings as are required for all opioids about the risk of misuse and abuse that can lead to addiction and overdose death. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

The Food and Drug Administration on Friday approved a new form of an extremely potent opioid to manage acute pain in adults, weeks after the chairman of the advisory committee that reviewed it asked the agency to reject it on grounds that it would likely be abused.

In approving the drug, the agency skirted its normal vetting process, these critics say.

Emalie Gainey, a spokeswoman for state Attorney General Maura Healey, said Healey has "serious concerns" about Dsuvia and "will be monitoring this closely".

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.

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