Democratic Senator Ed Markey of MA urged the FDA not to approve Dsuvia last month, saying "an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill".
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 pill is placed under the tongue for quick absorption and has the same impact as five milligrams of intravenous morphine, reported The Washington Post. FDA has restricted its use to certified medically-supervised health care settings only, such as hospitals, surgical centers, and emergency departments, and for administration by a health care professional. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.
In a statement, FDA Commissioner Scott Gottlieb M.D. explained that the drug could be of good use in cases where the patient may not be able to swallow properly, and how the Department of Defense worked closely with the sponsor in the development of the drug, particularly because of its need to treat soldiers in the battlefield. On October 12-so, not that long ago-AcelRx brought its sufentanil tablet Dsuvia before an FDA advisory committee.
The Food and Drug Administration's approval of a powerful new opioid stirred up fierce opposition in some consumer and healthcare circles after it was announced Friday, continuing debate about the agency's role and responsibility in the opioid crisis.
"DSUVIA will not be available in retail pharmacies or for outpatient use".
Gottlieb has pledged that the FDA would do more to balance efforts to curb the epidemic-which killed a record 49,000 users in 2017, according to preliminary data-with the needs of people who need strong pain relief. 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.
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. This will help the FDA evaluate future opioid medication safety and efficacy.
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.
Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says.