A tiny pill more potent than 1,000 times the strength of morphine has been approved for use by the Food and Drug Administration.
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.
A new tablet form of an ultra-powerful opioid is about to make its way into hospitals, despite the ongoing opioid crisis plaguing the U.S. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001. The Pentagon has spent millions of dollars helping to fund AcelRx's research, public documents show. In a statement, FDA Commissioner Scott Gottlieb, MD, sought to deflect criticism of the approval, saying that, "Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that's available to patients and providers".
Although the FDA is committed to reducing the opioid crisis and despite their claims to work in the interest of addiction-free drugs, the latest opioid may go against everything that has been said. However, despite the warnings, the opioid has been approved by the FDA for use in health-care. Avoiding an IV has the potential to offer efficiency improvements in healthcare settings and improve patient experience. Part of that effort may be a closer and more stringent assessment of the need for new opioid formulations going forward, Gottlieb added. It would not be available in retail pharmacies. The numbers say it all: More people die in the United States each year from drug overdoses than from breast cancer.
"The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds".
An opioid policy steering committee is developing new guidance documents to help the FDA "consider the benefits and risks of these products in the context of the crisis". The drug's manufacturer, AcelRx, said the drug will be marketed with the name Dsuvia and cost between $50 and $60 per dose.
Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says.