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07 November 2018, 10:29 | Silvia Roy
FDA OKs powerful opioid pill as alternative to IV painkiller
What makes this particular approval so interesting is that the drug has many outspoken critics.
In a highly controversial move, the Food and Drug Administration approved an especially powerful opioid painkiller despite criticism that the medicine could be a "danger" to public health.
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.
Dsuvia is a sublingual (meaning it is taken under the tongue) form of sufentanil (a synthetic opioid) that's delivered through a disposable, pre-filled, single-dose applicator, the FDA says.
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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.
Critics are blasting the FDA for approving Dsuvia as the country faces increasing opioid overdose deaths.
But Gottlieb stressed Friday that his agency has placed very tight restrictions on Dsuvia. "It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said in a statement.
More: The opioid crisis hits home. It will not be available at your local pharmacy and is designed only for use in a "certified medically-supervised healthcare settings".
"Because of the risks of addiction, abuse and misuse with opioids; Dsuvia is also to be reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia", according to a statement from Gottlieb about the drug's approval.
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.
The pills contain sufentanil, a chemical cousin of the opioid fentanyl. But Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky who chairs the committee, then took the rare step of publicly condemning that decision and urging the FDA to reject the drug.
AcelRx already has approval for 15- and 30-microgram versions of the drug in Europe.
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The manufacturer, a California company called AcelRx, will market the drug beginning in early 2019 under the name Dsuvia, at a wholesale price of $50 to $60 per dose. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.
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In the second half, I could understand some of the frustration because we produced some incredible chances and we didn't score. We don't know, a muscle problem , and we have to wait a little bit". "So I think he was really good for us".
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But that, I think, is sometimes the right time - is to say that I'm not on the down slide, a bit like [Carl] Froch. He is a good boxer, had good movement and he can put pressure on.