FDA Approves DSUVIA Sublingual Synthetic Opioid Formulation & Delivery System

FDA approves new opioid

Experts and elected officials are lambasting the Food and Drug Administration for approving a new opioid that is 500 times stronger than heroin as the nation is in the grip of an addiction crisis.

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 U.S. Food and Drug Administration has approved the marketing of an opioid named Dsuvia, with FDA Commissioner Dr. Scott Gottlieb posting a lengthy statement defending the decision. The medication, which comes in a single-use package, also should not be used for more than 72 hours. 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. As part of the program, the drug maker will monitor distribution and audit wholesalers' data, evaluate proper use in the healthcare setting, and monitor for diversion or abuse and decertify any healthcare setting that is noncompliant.

AcelRx Pharmaceuticals, in a statement, said the drug was long in the making. It is restricted to being used in certified medically supervised health care settings like hospitals, surgical centers, and emergency departments.

Critics blasted the agency for bringing a new opioid to market as the nation faces increasing opioid overdose deaths in what many call a crisis.

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The FDA also said it had signed a memorandum of understanding with the Defense Department to expedite availability of medical products, particularly those used to treat injuries in battlefield settings. And many of those will overdose and die.

U.S. Sen. Edward J. Markey sharply criticized an FDA advisory committee's vote to approve Dsuvia last month.

"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.

The statement noted the benefit the drug could have for soldiers injured on the battlefield. It is expected to be available in the first quarter of next year. "The agency is taking new steps to more actively confront this crisis while also paying careful attention to the needs of patients and physicians managing pain".

"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. She said caregivers can make these mistakes as they calculate the amount of clear liquid painkillers such as morphine to administer intravenously.

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