FDA Approves DSUVIA Sublingual Synthetic Opioid Formulation & Delivery System

FDA Approves DSUVIA Sublingual Synthetic Opioid Formulation & Delivery System

FDA Approves DSUVIA Sublingual Synthetic Opioid Formulation & Delivery System

"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", Gottlieb said in his written statement.

"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.

The Food and Drug Administration (FDA) approved a highly controversial opioid. The drug is called Dsuvia, which is a tablet version of an opioid marketed for intravenous delivery, but is administered under the tongue using a specially developed, single-dose applicator. 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 a year ago with 72,000 deaths - about 200 per day.

Critics are blasting the FDA for approving Dsuvia as the country faces increasing opioid overdose deaths. And many of those will overdose and die.

The drug is for very restricted use in operating rooms or on the battlefield.

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U.S. Sen. Edward J. Markey sharply criticized an FDA advisory committee's vote to approve Dsuvia last month. It would not be available in retail pharmacies.

However, the FDA claims to have a strict control on the use of drugs inside a medical facility. The most notable of these critics might actually be in-house: the chair of the FDA advisory committee, who also happens to be the chair for the consumer advocacy group Public Citizen. In many cases, illicit users obtain them from friends, relatives or rogue doctors and pharmacists, according to the SAMHSA survey. The military wants to explore whether the pill can be used as a battlefield painkiller that is less cumbersome than liquid analgesics.

Gottlieb said the drug will carry a boxed warning and won't be available at drugstores for patients to take home. The Pentagon has spent millions of dollars helping to fund AcelRx's research, public documents show.

Pamela Palmer, an anesthesiologist, said she founded the company to reduce the number of deaths caused by opioid dosing errors in hospitals and ambulatory care centers.

"It's a huge mistake", Wolfe said. 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.

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