FDA OKs Powerful New Opioid Dsuvia Despite Criticisms

Alicia Farmer
November 7, 2018

On Friday, new statistics released by the U.S. Drug Enforcement Administration found the number of opioid overdose deaths in the United States reached a new record past year with 72,000 deaths - about 200 per day.

The FDA announced its approval November 2 of a new prescription opioid called Dsuvia, despite public and medical criticism for the drug's approval in the midst of the opioid epidemic, according to STAT.

The drug is five to 10 times more potent than pharmaceutical fentanyl.

But those restrictions are not sufficient, claims Senator Ed Markey (D-MA), who blasted the FDA for failing to prove that the drug has enough "unique benefits over other available FDA-approved opioid products" to justify the risk of abuse.

"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group.

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

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 drug itself is only allowed for use in health-care settings and perhaps the battlefield and is not available to be sold separately at retail pharmacies. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country. AcelRx Pharmaceticals, maker of the drug, explains that, in many care settings-including battlefield settings-patients may not have readily available access to intravenous (IV) treatments for pain, and intramuscular injections (currently the standard of care for battlefield patients) are not as effective as IV options at providing timely relief, and may not be effective in cases of severe trauma that involves hypovolemic shock. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001.

"I am very disappointed with the decision of the agency to approve Dsuvia". Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

The FDA is taking some precautions in the hopes that the drug will not be abused.

"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.

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