The Food and Drug Administration approved a drug called Dsuvia Friday.
Democratic Senator Ed Markey of MA urged the FDA not to approve Dsuvia last month, saying "an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill". The drug is called Dsuvia, which is a tablet version of an opioid marketed for intravenous delivery, but is administered under the tongue using a specially developed, single-dose applicator.
"To that end, I've asked the professional staff at the FDA to evaluate a new framework for opioid analgesic approvals", he said. In a lengthy statement, Scott Gottlieb, FDA Commissioner, said there will be "very tight restrictions" placed on its distribution and it is intended only for supervised settings like hospitals. But Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky who chairs the committee, then took the rare step of publicly condemning that decision and urging the FDA to reject the drug.
Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis.
"To address concerns about the potential risks associated with Dsuvia, this product will have strong limitations on its use", Gottlieb said. "We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval - the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction", Dr. Gottlieb said. The opioid in question is a highly potent, and unsafe drug that has more risks than benefits in health-care. The numbers say it all: More people die in the USA each year from drug overdoses than from breast cancer.
But Dsuvia's approval comes amid controversy, with an epidemic of opioid abuse continuing to ravage the United States.
Drug overdose deaths hit the highest level ever recorded in the United States previous year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. On October 12-so, not that long ago-AcelRx brought its sufentanil tablet Dsuvia before an FDA advisory committee.
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.
AcelRx already has approval for 15- and 30-microgram versions of the drug in Europe. 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.