FDA OKs powerful opioid pill as alternative to IV painkiller

FDA OKs powerful opioid pill as alternative to IV painkiller

Each would come in a plastic applicator that looks like a syringe.

The medication is called DSUVIA; it is a single-dose 30 mcg sublingual tablet of sufentanil.

Leading the dissent was Raeford Brown, the chairman of an FDA advisory committee that reviewed AcelRx Pharmaceuticals' Dsuvia last month and ultimately recommended its approval in a 10-3 vote.

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. Dr. Palmer says that the drug will not be dispensed to patients via pharmacy; instead, it can only be administered by a healthcare provider in a medical center. "We are committed to the safe and effective administration of Dsuvia through diligent adherence to our FDA-approved Risk Evaluation and Mitigation Strategies program".

Sidney Wolfe of Public Citizen's Health Research Group, a consumer group, called Gottlieb's statement "empty rhetoric" and said the agency missed a big opportunity when it approved the pill.

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. "It will be taken by medical personnel and others for whom it has not been prescribed. This action is inconsistent with the charter of the agency", Brown said in a statement Friday. Therefore, if there is any diversion, then the risk is among the medical personnel themselves, no one else. Fewer than 1 percent of people said they acquired opioids that way.

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FDA Commissioner Scott Gottlieb announced approval of AcelRx Pharmaceuticals' painkiller Dsuvia Friday, an announcement that largely went under the public's radar, except for a swift denouncement by U.S. Sen.

Gottlieb said military use of the drug was "carefully considered in this case" as the FDA wants to "make sure our soldiers have access to treatments that meet the unique needs of the battlefield".

Pamela Palmer, an anesthesiologist, said she founded the company to reduce the number of deaths caused by opioid dosing errors in hospitals and ambulatory care centers.

"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. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.

Including brand name and generic drugs, there are almost 400 opioids now on the market.

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