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. "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. And in doing so, the agency addressed wider regulatory thinking for endorsing such a medicine amid nationwide angst about overdoses and deaths attributed to opioids.
To that, however, anesthesiologist Dr. Pamela Palmer-who is also the co-founder of AcelRx-argues that "diversion" of Dsuvia is extremely low.
"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 said in an agency news release.
Dsuvia "works exactly the same as morphine and other opioids do", Alan says. Acknowledging the criticism, he said he's asked FDA staff to "evaluate a new framework" for the approval of new opioid drugs that will clearly outline how the agency considers benefits and risks.
According to Gottlieb, there are very tight limitations for the use of the drug.
The tiny pill was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield.
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Sanjay Gupta that opioids are the biggest crisis facing the nation, a crisis fueled by overprescribing.
There's more on pain control at the American Society of Anesthesiologists.
"DSUVIA will not be available in retail pharmacies or for outpatient use". The medication, which comes in a single-use package, also should not be used for more than 72 hours.
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. Most of that was the result of a record number of opioid-related deaths. She said caregivers can make these mistakes as they calculate the amount of clear liquid painkillers such as morphine to administer intravenously. It is the tablet version of an opioid that's now marketed for intravenous delivery, and was also approved in Europe just last July under the brand name Dzuveo.
Furthermore, others also noted that the drug could be easily diverted by medical personnel, despite risk mitigation plans, and with the restriction that it could only be used in certified medically supervised healthcare settings.