FDA approves highly effective new opioid regardless of ongoing epidemic

FDA OKs powerful opioid pill as alternative to IV painkiller

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

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.

Gottlieb said Dsuvia, which is administered under the tongue through a disposable, pre-filled, single-dose applicator, "is restricted to use in certified, medically supervised health care settings - such as hospitals, surgical centers and emergency departments - for administration by a health care professional".

Scott Gottlieb was quick to defended the approval in a statement Friday: "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". Acknowledging the criticism, he said he's asked FDA staff to "evaluate a new framework" for the approval of new opioid drugs that will clearly outline how the agency considers benefits and risks. "It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said in a statement. Most of that was the result of a record number of opioid-related deaths.

For Dsuvia specifically, Gottlieb referenced the opioid multiple times as a Pentagon priority, citing its potential use on the battlefield to treat soldiers through its sublingual formulation.

Gottlieb said the drug will carry a boxed warning and won't be available at drugstores for patients to take home.

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The drug is also only for use by patients who can not tolerate other painkillers, or for whom other painkillers have failed or are expected to fail. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001. Alan says the concern around the drug is "valid given the potential for abuse". Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

"I am very disappointed with the decision of the agency to approve Dsuvia".

Dsuvia was rejected by an FDA advisory committee in 2017 because the committee wanted more data.

Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says.

"As a single-dose, non-invasive medication with a rapid reduction in pain intensity, DSUVIA represents an important alternative for healthcare providers to offer patients for acute pain management", Dr. David Leiman, clinical assistant of surgery at University of Texas at Houston, said in a statement from AcelRx.

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