Published: Wed, November 07, 2018
Medicine | By Tracy Klein

FDA Approves Powerful Opioid Pill as IV Painkiller Alternative

FDA Approves Powerful Opioid Pill as IV Painkiller Alternative

It's intended for short-term use only, and should not be used for more than 72 hours.

The manufacturer, a California company called AcelRx, will market the drug beginning in early 2019 under the name Dsuvia, at a wholesale price of $50 to $60 per dose.

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".

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". The drug itself is only allowed for use in health-care settings and perhaps the battlefield and is not available to be sold separately at retail pharmacies. The goal, of course, was for the committee to determine the drug's overall safety and efficacy; and the FDA usually follows whatever guidance their committees provide.

"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 decision has met a lot of criticism because the opioid is 5-10 times more potent than pharmaceutical fentanyl. On Friday, new statistics released by the U.S. Drug Enforcement Administration found the number of opioid overdose deaths in the United States reached a new record past year with 72,000 deaths - about 200 per day. Although the FDA has pledged to curb the on-going crisis, the statement made by the commissioner gives a clear insight as to how the agency will be moving forward with its drug evaluations. AcelRx returned to the committee this year, and on October 12 the drug was recommended for approval. And in doing so, the agency addressed wider regulatory thinking for endorsing such a medicine amid nationwide angst about overdoses and deaths attributed to opioids.

The FDA says that controls on drugs inside medical facilities are tight and the greatest risk of diversion is among medical personnel themselves. And many of those will overdose and die. Most of that was the result of a record number of opioid-related deaths. It is the tablet version of an opioid that's now marketed for intravenous delivery, and was also approved in Europe just last July under the brand name Dzuveo.

"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.

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