FDA Approves DSUVIA Sublingual Synthetic Opioid Formulation & Delivery System

FDA approves new opioid

More importantly, though, some critics argue that the drug's size (about 3mm wide) and potency (at least 10 times more powerful than fentanyl) will certainly have more appeal to those looking to misuse/abuse the drug or to sell it.

News outlets have decried the approval and emphasized sufentanil's effects as "500 times more powerful than morphine;" however, Pamela Palmer, MD, PhD, chief medical officer of AcelRx Pharmaceuticals, which developed the drug, explained in an interview with Pharmacy Times' sister publication, MD Magazine, that these overstatements are misguided.

Dsuvia is a sublingual (meaning it is taken under the tongue) form of sufentanil (a synthetic opioid) that's delivered through a disposable, pre-filled, single-dose applicator, the FDA says. However, despite the warnings, the opioid has been approved by the FDA for use in health-care. As such, "We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", said AcelRx's CEO, Vince Angotti, in a statement.

Scott Gottlieb was quick to defended the approval in a statement Friday: "The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain".

"DSUVIA will not be available in retail pharmacies or for outpatient use". The FDA commissioner has also taken an unusual stance by saying that he wants more authority for the agency to consider similar drugs in the market which would make it easier for the agency to turn down applications for opioids in the future.

Gottlieb also points out in his statement that it can help in special circumstances in which a patient may not be able to swallow, adding that there could be potential uses on the battlefield. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country.

Following the approval of Dsuvia, Gottlieb acknowledged that opioids are a unique class of medications.

Drug overdose deaths hit the highest level ever recorded in the United States past year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. "It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said in a statement. It's an alternative to IV painkillers used in hospitals. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo.

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. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts.

Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says.

Related:

Comments

Latest news

President Trump Holds Post-2018 Midterm Election Press Conference
He then took questions, and things got testy quickly as he sparred with reporters - especially CNN's Jim Acosta . You are a rude awful person. 'CNN should be ashamed of itself having you work for them.

City so good or Saints so bad?
The 27-year-old has only featured in one Europa League match so far this campaign, and even that was as a substitute against MOL Vidi.

Queen Elizabeth Reportedly Invites Meghan Markle's Mother Doria Ragland for Christmas
Doria Ragland , 62, reportedly impressed senior royals with her demeanour at the wedding of her daughter and Prince Harry .

'Red Dead Redemption 2' Missing Characters Bug Fix In the Works
Not even 24 hours after its release, Red Dead Redemption 2 was being labeled the best game of the year, and trust me, it is. Players will have the freedom of decisions in this lovely landscape and each choice will have its own immediate effect .

Man escapes death penalty after admitting killing wife and two daughters
Christopher Watts is in court for his arraignment hearing at the Weld County Courthouse on August 21, 2018 in Greeley, Colorado. Colorado law requires that a first-degree murder conviction brings a mandatory life sentence without the possibility of parole.

Other news