"We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval - the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction", he said.
But critics of the drug and its potency - it's 10 times stronger than fentanyl - are tired that such a pill could add to the country's already alarming opioid epidemic.
Critics blasted the agency for bringing a new opioid to market as the nation faces increasing opioid overdose deaths in what many call a crisis. Approval of the drug was highly criticized; Raeford Brown, MD, chair of the FDA's Anesthetic and Analgesic Drug Products Committee, urged the FDA not to approve Dsuvia. In a statement, FDA Commissioner Scott Gottlieb said that "very tight restrictions" will be placed on the drug.More news: Harvick makes Championship 4 with OT win at Texas
Sidney Wolfe of Public Citizen's Health Research Group, a consumer group, called Gottlieb's statement "empty rhetoric" and said the agency missed a big opportunity when it approved the pill. AcelRx Pharmaceticals, maker of the drug, explains that, in many care settings-including battlefield settings-patients may not have readily available access to intravenous (IV) treatments for pain, and intramuscular injections (currently the standard of care for battlefield patients) are not as effective as IV options at providing timely relief, and may not be effective in cases of severe trauma that involves hypovolemic shock.
More: Drugs kill more Americans than guns, cars and AIDS. Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001.
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. It notes that the Department of Defense was involved in its development and that it was a priority for the Pentagon because it "fills an unmet need".More news: 7-Eleven is testing a ‘scan and go’ mobile checkout system
The pills contain sufentanil, a chemical cousin of the opioid fentanyl. An estimated 51 million of these visits are to emergency departments (ED), with an estimated 18 million of these ED patients receiving an IV only for pain management.
AcelRx Pharmaceuticals, in a statement, said the drug was long in the making.
The Food and Drug Administration on Friday approved a new form of an extremely potent opioid to manage acute pain in adults, weeks after the chairman of the advisory committee that reviewed it asked the agency to reject it on grounds that it would likely be abused. Company executives said they expect to launch Dsuvia in the first quarter of 2019. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.More news: PSG's Neymar accuses referee of being "disrespectful" to him