FDA approves new, powerful drug amidst opioid crisis

08 November, 2018, 08:34 | Author: Lillian Steele
  • FDA OKs powerful opioid pill as alternative to IV painkiller

A new ultra-powerful opioid is about to make its way into hospitals.

But U.S. Sen. Edward J. Markey, D-Mass., sharply criticized that vote, saying Dsuvia is an opioid painkiller up to 10 times more powerful than fentanyl and 1,000 times more powerful than morphine.

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. 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 previous year with 72,000 deaths - about 200 per day.

"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. The numbers say it all: More people die in the United States each year from drug overdoses than from breast cancer.

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Can the drug be prevented from being abused and misused?

"DSUVIA will not be available in retail pharmacies or for outpatient use". The objective, 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. The guidelines would allow the agency to consider a narcotic's benefit to public health, its risk of being diverted for inappropriate use or abuse and its unique benefits to groups of people in pain before deciding to approve an opioid.

Other restrictions, according to the FDA, include that it cannot be used for more than 72 hours and will have the same black-box warnings as are required for all opioids about the risk of misuse and abuse that can lead to addiction and overdose death. It is expected to be available in the first quarter of next year. In many cases, illicit users obtain them from friends, relatives or rogue doctors and pharmacists, according to the SAMHSA survey. Dr. Palmer says that the drug will not be dispensed to patients via pharmacy; instead, it can only be administered by a healthcare provider in a medical center. In its newly approved form, it is an option for patients with acute pain who are not able to receive an IV or are unable to swallow a pill. The Pentagon has spent millions of dollars helping to fund AcelRx's research, public documents show.

"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", Gottlieb said in an agency news release. 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.

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