In a statement he noted that "an opioid that is 1,000 times more powerful than morphine is 1,000 times more likely to be abused, and 1,000 times more likely to kill". It is up to 10 times more powerful than fentanyl and 1,000 times more powerful than morphine, he warned. The tiny pill - just three millimeters in diameter - is likely to worsen the nation's drug crisis, according to critics and the head of the FDA's advisory committee on painkillers. "The military application for this new medicine was carefully considered in this case", Dr. Gottlieb said in a statement.
The FDA has approved this new drug in the midst of a severe opioid epidemic in the country.
"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", Gottlieb's wrote.
The drug is for very restricted use in operating rooms or on the battlefield. The medication, which comes in a single-use package, also should not be used for more than 72 hours.
Gottlieb said he would bring a plan to the FDA's Opioid Policy Steering Committee and perhaps Congress.
However, the FDA claims to have a strict control on the use of drugs inside a medical facility.
"In this way, [drug companies] would know up front where the opportunities are for developing new drugs that meet the FDA's standards for safety and effectiveness", he wrote. Each would come in a plastic applicator that looks like a syringe. It would not be available in retail pharmacies. Company executives said they expect to launch Dsuvia in the first quarter of 2019.
AcelRx already has approval for 15- and 30-microgram versions of the drug in Europe.
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. Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths. "It will be taken by medical personnel and others for whom it has not been prescribed".
More: Drugs kill more Americans than guns, cars and AIDS.
Brown added that he has personally tried to resuscitate health care providers who abuse sufentanil, "some successfully". The pill from AcelRx Pharmaceuticals contains the same decades-old painkiller often given in IV form or injection to surgical patients and women in labor. According to Gottlieb, "This opioid formulation, along with Dsuvia's unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation's soldiers on the battlefield".
Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.