FDA Approves Sublingual Opioid Sufentanil

FDA Approves Sublingual Opioid Sufentanil

It's 10 times more powerful than Fentanyl, making it 1,000 times more potent than morphine. It is 10 times stronger than fentanyl, a parent drug that is often used in hospitals but is also produced illegally in forms that have caused tens of thousands of overdose deaths in recent years. "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 drug is a 30-microgram pill that packs the same punch as 5 milligrams of intravenous morphine, according to the Washington Post.

The FDA announced its approval November 2 of a new prescription opioid called Dsuvia, despite public and medical criticism for the drug's approval in the midst of the opioid epidemic, according to STAT. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX. On October 12-so, not that long ago-AcelRx brought its sufentanil tablet Dsuvia before an FDA advisory committee. 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 a year ago with 72,000 deaths - about 200 per day. Further, the drug will be limited for use in patients whom other analgesics were not tolerated, or are not expected to be tolerated. The opioid in question is a highly potent, and risky drug that has more risks than benefits in health-care.

Can the drug be prevented from being abused and misused? Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it.

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Metropolitan Police said five men turned themselves in late on Monday after authorities launched an investigation into the video. Another one makes ambulance noises before saying: "That's what happens when they don't pay their rent".

Another criticism to be voiced is that Dsuvia is unnecessary: a drug that will not really add any benefit to an already saturated-and very unstable-opioid market. The medication, which comes in a single-use package, also should not be used for more than 72 hours.

And even as his agency gave the nod to Dsuvia, Gottlieb said other steps are being taken to restrict access to highly potent opioids. "DSUVIA will only be distributed to health care settings certified in the DSUVIA Risk Evaluation and Mitigation Strategy (REMS) program following attestation by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of DSUVIA", AcelRx said.

Including brand name and generic drugs, there are almost 400 opioids now on the market.

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