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Sober Nation

Putting Recovery On The Map

11-07-18 | By

FDA Approved New Opioid Stronger 500 Times Stronger Than Morphine. And We’re Pissed.

This is Dsuvia.

Dsuvia is 10 times stronger than Fetanyl, and 1,000 more potent than morphine.

And just this past week, on the brink of an ever worsening opioid crisis, the Food and Drug Administration (FDA) put their stamp of approval on this drug for managing acute pain in adults.

What Exactly Is Dsuvia?

Dsuvia is a 30-microgram tablet form, designed to be taken sublingually – under the tongue by a special applicator that dispenses one dose at a time. The FDA’s Anesthetic and Analgesic Drug Product Advisory Committee voted in favor of the new drug, formulated by AcelRX Pharmaceuticals, on October 12. The agency adopted the approval on November 2. The drug should be available in early 2019.

AcelRx has publicly announced that the drug will not be abused like Fentanyl, morphine or other drugs because the pill comes in a single dose, it’s not for home use, and not available in pharmacies. AcelRx’s chief executive also issued a statement reporting the company’s risk evaluation and mitigation strategy which includes auditing distribution data and ensuring that the drug is being administered properly.

In addition to the distributor, the FDA says that is has implemented safety measures assuring that the drug is “restricted to use in certified medically-supervised healthcare settings like hospitals, surgical centers and emergency departments.”

The drug was also requested by the Pentagon for battlefield use, where intravenous painkillers can often be ineffective.

“A Thousand Times More Likely To Kill”

Despite the public statements and promises of CEO’s and officials, there are many who are outraged by the drug’s approval due to the opioid crisis that continues ravage the United States – fearful that the new drug could worsen the crisis. In 2017, there were over 72,000 drug overdose deaths in the Nation alone.

Massachusetts Senator Edward Markey and three other senators signed a letter last week demanding the FDA not green-light the drug, saying “an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill.”

Will Dsuvia Be Any Different?

Even Dr. Raeford Brown, the chairman of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), urged the agency’s top officials to reject Dsuvia in a strongly worded letter co-signed by leaders of the consumer advocacy group Public Citizen. Brown expressed strong doubts that the agency has the capability to “regulate [Dsuvia] so that it is used only in closely controlled settings” and “only as described in the label.”

According to Brown, historically, the FDA has not demonstrated an ability to enforce such controls with any other opioid, and “there is currently no educational nor regulatory scheme” in place that guarantees the agency’s approach to regulating Dsuvia will be any different.

The Doctor also noted that the IV form of sufentanil is so potent that “abusers … often die when they inject the first dose,” and warned that regardless of it’s form, the small dosing volume made it easier to divert and abuse.

Could this cause a huge threat to the country where drug overdoses are killing more people today than car accidents? Tell us your thoughts below.


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