The Food and Drug Administration approved a powerful new opioid Friday for use in health care settings, rejecting criticism from some of its own advisers that it would inevitably be diverted to illicit use and cause more overdose deaths. More importantly, though, some critics argue that the drug's size (about 3mm wide) and potency (at least 10 times more powerful than fentanyl) will certainly have more appeal to those looking to misuse/abuse the drug or to sell it.
The U.S. Food and Drug Administration has approved the marketing of an opioid named Dsuvia, with FDA Commissioner Dr. Scott Gottlieb posting a lengthy statement defending the decision. 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.
Other restrictions, according to the FDA, include that it cannot be used for more than 72 hours and will have the same black-box warnings as are required for all opioids about the risk of misuse and abuse that can lead to addiction and overdose death. It'll also help them evaluate the risk of a drug being misused or abused and also the unique benefits of the drug to the people in pain. Alan says the concern around the drug is "valid given the potential for abuse". 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.
The chair of an FDA advisory panel that considered whether the drug should be approved, Dr. Raeford Brown, called it a "danger to the general public health" last month. The FDA endorsed Dsuvia, which can be applied once under the tongue and benefit soldiers on the battlefield where IVs can be impractical. And many of those will overdose and die. It would not be available in retail pharmacies. A spokeswoman said the company is not providing information on expected sales.More news: Mel B says Spice Girls reunion isn't about money
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"The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain", Gottlieb wrote.
"It's a huge mistake", Wolfe said.
"As a single-dose, non-invasive medication with a rapid reduction in pain intensity, DSUVIA represents an important alternative for healthcare providers to offer patients for acute pain management", Dr. David Leiman, clinical assistant of surgery at University of Texas at Houston, said in a statement from AcelRx.
In one study, the pill provided about the same pain relief to patients as IV morphine.