The tablet, placed under the tongue with a dispenser, starts reducing pain in 15 to 30 minutes. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX. Drug overdose estimates from the Centers for Disease Control and Prevention hit record highs the past two years.
At the same time, FDA Commissioner Scott Gottlieb issued an unusual statement saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market. Alan says the concern around the drug is "valid given the potential for abuse".
A panel of FDA advisers had earlier voted 10 to three in favor of the pill called Dsuvia, but in a rare response, the panel's chairman joined critics in urging the FDA to reject it. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo.
"Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect", Brown said in his joint statement with Public Citizen. "Addressing it is a public health priority for the FDA".
The consumer watchdog group Public Citizen has also come out strongly against approval.
For instance, it may not be administered at home, and can only be administered by a health care provider, which means that the drug will not be available at retail pharmacies.
Kolodny called Dsuvia an "exceptionally dangerous" drug that is 10 times stronger than fentanyl, which is 50 times stronger than heroin. According to critics, the decision will only fuel the United States' drug crisis even further rather than improving it. "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". The military wants to explore whether the pill can be used as a battlefield painkiller that is less cumbersome than liquid analgesics.
As the worst drug crisis in US history has accelerated, agency critics and some public officials have clamored for that holistic approach to narcotic painkillers, instead of the FDA's practice of evaluating each opioid application on its own.
Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says. "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". Part of that effort may be a closer and more stringent assessment of the need for new opioid formulations going forward, Gottlieb added. Angotti noted that the drug will be subject to a Risk Evaluation and Mitigation Strategy program.
- All 78 child hostages released in Cameroon, two teachers held
- Spice Girls to Make Over $3 Million Each for UK Tour
- United States elects record number of women to House
- Armed Militia Groups Head To The Border, Sparking Military Concerns
- The Trial of Mexican Drug Lord "El Chapo" Starts Monday in Brooklyn
- Janet Jackson speaks out for 'women whose voices have been silenced'
- Chris Watts: Dad admits to killing family to avoid death penalty
- Ron DeSantis Defeats Andrew Gillum to Become Florida’s Governor
- ATP Finals: Rafael Nadal ruled out of London event
- FAA issues 737 MAX emergency AD