FDA Approves Powerful Opioid Pill as IV Painkiller Alternative

Henrietta Brewer
November 7, 2018

Despite concerns and controversies, the U.S. Food and Drug Administration (FDA) just approved an opioid that's said to be 10 times more powerful than fentanyl.

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

The new, single-dose tablet version of the pain killer, mean to be taken under the tongue, can only be given in hospitals and is meant for those who can't take an IV. However, despite the warnings, the opioid has been approved by the FDA for use in health-care. "I recognize that the debate goes beyond the characteristics of this particular product or the actions that we're taking to mitigate this drug's risks and preserve its differentiated benefits".

"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group.


"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.

According to a prepared statement from AcelRx, in a randomized, double-blind, placebo-controlled clinical study, which enrolled 161 patients, ages 18 to 69 years, the medication demonstrated a statistically greater summed pain intensity difference from baseline over the first 12 hours of the study (SPID12) compared to placebo.

Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said.

FDA Commissioner Scott Gottlieb issued an unusual statement saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market, which might allow the agency to turn down future applications for new opioid approvals.


The tiny pill was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield.

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". An estimated 51 million of these visits are to emergency departments (ED), with an estimated 18 million of these ED patients receiving an IV only for pain management.

Additionally, four Democratic senators had urged Gottlieb to deny approval on Dsuvia until Brown and other drug safety committee members could participate in the decision and vote, in a letter they sent last Wednesday.

Dsuvia was rejected by an FDA advisory committee in 2017 because the committee wanted more data. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.


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