Ultra-Powerful Opioid Approved by FDA

FDA approves new opioid

FDA approves new opioid

Dsuvia (sufentanil) is an exceptionally powerful opioid, roughly 1,000 times stronger than morphine and more potent than fentanyl.

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.

The drug is a 30-microgram pill that packs the same punch as 5 milligrams of intravenous morphine, according to the Washington Post. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001.

Along with the approval, Commissioner Scott Gottlieb released a statement of more than 2,200 words explaining the decision as well as how the agency will consider future opioid applicants.

"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 Food and Drug Administration approved a drug called Dsuvia Friday.

The statement noted the benefit the drug could have for soldiers injured on the battlefield.

USA regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals. Sufentanil is intended for use within health-care settings and would not be available in pharmacies. "It can't be dispensed to patients for home use and should not be used for more than 72 hours".

Sanjay Gupta that opioids are the biggest crisis facing the nation, a crisis fueled by overprescribing.

Still, critics hold that the drug does not serve a unique need, despite its seemingly more controlled administration environment.

"As a single-dose, non-invasive medication with a rapid reduction in pain intensity, DSUVIA represents an important alternative for healthcare providers to offer patients for acute pain management", Dr. David Leiman, clinical assistant of surgery at University of Texas at Houston, said in a statement from AcelRx.

Pamela Palmer, an anesthesiologist, said she founded the company to reduce the number of deaths caused by opioid dosing errors in hospitals and ambulatory care centers.

And even as his agency gave the nod to Dsuvia, Gottlieb said other steps are being taken to restrict access to highly potent opioids. "The FDA has implemented a REMS that reflects the potential risks associated with this product and mandates that Dsuvia will only be made available for use in a certified medically-supervised heath care setting, including its use on the battlefield". 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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