Monday, 21 January, 2019


US FDA Approves New-and Very Potent-Painkiller, Despite Warnings

FDA OKs powerful opioid pill as alternative to IV painkiller FDA OKs powerful opioid pill as alternative to IV painkiller
Patty Aguilar | 07 November, 2018, 23:29

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.

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.

The drug is a 30-microgram pill that packs the same punch as 5 milligrams of intravenous morphine, according to the Washington Post.

Brown, four U.S. Senators and the advocacy group Public Citizen have predicted that Dsuvia will be diverted to illicit use and cause more opioid overdose deaths.

To that, however, anesthesiologist Dr. Pamela Palmer-who is also the co-founder of AcelRx-argues that "diversion" of Dsuvia is extremely low.

"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.

AcelRx Pharmaceuticals, in a statement, said the drug was long in the making. However, despite the warnings, the opioid has been approved by the FDA for use in health-care.

The statement noted the benefit the drug could have for soldiers injured on the battlefield.

The approval comes just a bit more than a year after President Donald Trump declared the opioid crisis a public health emergency.

The medication won't be available at pharmacies and shouldn't be used for more than 72 hours. Drug overdose estimates from the Centers for Disease Control and Prevention hit record highs the past two years. 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.

And even as his agency gave the nod to Dsuvia, Gottlieb said other steps are being taken to restrict access to highly potent opioids. 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. "DSUVIA will only be distributed to health care settings certified in the DSUVIA Risk Evaluation and Mitigation Strategy (REMS) program following attestation by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of DSUVIA", AcelRx said.

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