ibusinesslines.com
ibusinesslines.com December 17, 2018


FDA Approves DSUVIA Sublingual Synthetic Opioid Formulation & Delivery System

07 November 2018, 11:27 | Melissa Porter

FDA Approves Powerful Opioid Pill That’s 10 Times Stronger Than Fentanyl

The FDA just approved an opioid painkiller 10 times more powerful than fentanyl

Ruling against the recommendation of one of its chief experts, the U.S. Food and Drug Administration on Friday approved an extremely potent new opioid painkiller, Dsuvia.

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

The product, Dsuvia, consists of the synthetic opioid sufentanil, which is 500 times stronger than morphine, packaged in a plastic applicator for faster pain relief.

He states that it is through the restricted use that the drug could be prevented from being abused, misused, or even diverted. 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. "To what extent should we evaluate each opiod exclusively on its own merits, and to what extent should we also consider ... the epidemic of opioid misuse and use that's gripping our nation?"

"To that end, I've asked the professional staff at the FDA to evaluate a new framework for opioid analgesic approvals", he said.

Drug overdose deaths hit the highest level ever recorded in the United States previous year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. In a lengthy statement, Scott Gottlieb, FDA Commissioner, said there will be "very tight restrictions" placed on its distribution and it is intended only for supervised settings like hospitals.


Gottlieb said he would bring a plan to the FDA's Opioid Policy Steering Committee and perhaps Congress. "I will continue to hold the agency accountable for their response to the worst public health problem since the 1918 influenza epidemic". The agency would look into all of these factors before making a decision on approving an opioid or not. Other news on opioids focuses on the FDA's armed hunt for counterfeit drugs and the continued threat of fentanyl and heroin.

AcelRx Pharmaceuticals, in a statement, said the drug was long in the making. The drug is 30-microgram in pill form.

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

However, despite the FDA's best wishes and intentions, a lot of people have come forward with criticism. "It will be taken by medical personnel and others for whom it has not been prescribed".

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

The rate of overdose deaths among health care workers is relatively high, however, according to an August study by the Centers for Disease Control and Prevention, with 876 succumbing to prescription opioids between 2007 and 2012. It remains to be seen how this plays out.



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