Mass. pols wary of new Rx opioid

Experts and elected officials are lambasting the Food and Drug Administration for approving a new opioid that is 500 times stronger than heroin as the nation is in the grip of an addiction crisis.

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. Edward J. Markey.

“This new opioid will soon be hitting the market in the middle of the worst drug crisis this country has ever seen,” the Bay State senator said.

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.”

He also called the drug “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.”

Dr. Andrew Kolodny, director of Physicians for Responsible Opioid Prescribing, yesterday called that claim “ridiculous” and “utter nonsense.”

“We already have products that would work just as quickly on the battlefield,” said Kolodny, who is also co-director of Opioid Policy Research at Brandeis University’s Heller School for Social Policy and Management.

Kolodny called Dsuvia an “exceptionally dangerous” drug that is 10 times stronger than fentanyl, which is 50 times stronger than heroin.

AcelRx Pharmaceuticals, in a statement, said the drug was long in the making.

“The FDA approval of Dsuvia is the culmination of nearly 15 years of research to improve the standard of care for managing acute pain in medically supervised settings,” said Dr. Pamela Palmer, cofounder and chief medical officer of AcelRx.

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