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FDA Approves DSUVIA Sublingual Synthetic Opioid Formulation & Delivery System

07 November 2018

A new opioid tablet that is 1,000 times more potent than morphine and 10 times stronger than fentanyl was approved by the Food and Drug Administration Friday as a fast-acting alternative to IV painkillers used in hospitals.

As the worst drug crisis in USA history has accelerated, agency critics and some public officials have clamored for that holistic approach to narcotic painkillers, instead of the FDA's practice of evaluating each opioid application on its own.

Dsuvia is a sublingual (meaning it is taken under the tongue) form of sufentanil (a synthetic opioid) that's delivered through a disposable, pre-filled, single-dose applicator, the FDA says. Critics point out that this comes amid an opioid epidemic in the United States - which led to more than 72,000 deaths in 2017 alone. The Pentagon has spent millions of dollars helping to fund AcelRx's research, public documents show.

In a statement, he said, "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".

Critics are blasting the FDA for approving Dsuvia as the country faces increasing opioid overdose deaths. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.

According to a prepared statement from AcelRx, in a randomized, double-blind, placebo-controlled clinical study, which enrolled 161 patients, ages 18 to 69 years, the medication demonstrated a statistically greater summed pain intensity difference from baseline over the first 12 hours of the study (SPID12) compared to placebo. Further, the drug will be limited for use in patients whom other analgesics were not tolerated, or are not expected to be tolerated. Part of that effort may be a closer and more stringent assessment of the need for new opioid formulations going forward, Gottlieb added.

More: Drugs kill more Americans than guns, cars and AIDS.

The same drug, with the chemical name sufentanil, is already available as an IV medication.

"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 related to battlefield wounds", he wrote. It will not be available at your local pharmacy and is designed only for use in a "certified medically-supervised healthcare settings". 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.

FDA Approves DSUVIA Sublingual Synthetic Opioid Formulation & Delivery System