Treatment at a Cost – When Painkillers Could Double Cross

By Rajaneesh K. Gopinath, Ph.D.

The entry of a new powerful analgesic into the clinic sparks debate, as it is touted to be one thousand times stronger than morphine and could potentially lead to opioid addiction.

On November 2^nd, AcelRx Pharmaceuticals, Inc. announced the approval of their analgesic, Dsuvia (Sufentanil) by the US Food and Drug Administration (USFDA). Formulated as a 30 microgram (mcg) sublingual (under the tongue) tablet, it is approved for the treatment of adult patients who experience moderate-to-severe acute pain and have no alternative besides using an opioid analgesic. The medicine is designed only to be administrated by a certified health care professional under strict, medically-supervised health care settings such as hospitals, surgical centers, and emergency departments.

History and Development

Sufentanil has been around since the 1980s when it was used intravenously as outpatient anesthesia, but to prevent misuse or abuse, Dsuvia will not be prescribed for outpatient use. Moreover, it is developed as a non-invasive, single-strength product delivered through a disposable, pre-filled, single-dose applicator to avoid dosing errors. The final product is much improved, thanks to the recommendations suggested by the FDA in their response to the initial new drug application submitted by AcelRx in December 2016. The response letter provided two major recommendations needed for resubmission. The first was the collection of additional data on at least 50 patients to assess the safety and second, to ensure proper administration of the tablet with the single-dose applicator.

Clinical Trial

The efficacy of DSUVIA was evaluated by Study 202 and Study 301, two pivotal, double-blind, randomized, placebo-controlled, multi-center clinical trials conducted in the United States. These studies included a total of 261 patients in postoperative settings. Study 302 and Study 303 also provided supportive evidence of efficacy. All studies were designed with inputs from the FDA.

Raging Criticism and Debate

Dsuvia was evaluated by the FDA’s advisory committee on October 12^th and was voted 10-3 in favor of its approval. The decision was immediately met with strong criticism from various quarters citing reasons for the drug overdose epidemic that already cripples the nation. Ed Markey of Massachusetts was one of the four senators who strongly opposed the approval. “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.”, he said in a statement.

He specifically pointed out that the voting occurred in the absence of the panel’s chair Dr. Raeford Brown. Dr. Brown is a Professor of Anesthesiology and Pediatrics at the University of Kentucky and Chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee that recommended Dsuvia’s approval. In a strongly worded letter, Dr. Brown urged the FDA not to approve the drug. “I am very disappointed with the decision of the agency to approve Dsuvia. This action is inconsistent with the charter of the agency,” he said.

However, the FDA commissioner Dr. Scott Gottlieb defended the decision assuring that tight restrictions are in place to “help prevent misuse and abuse.” The drug is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC).

References

1. http://ir.acelrx.com/news-releases/news-release-details/acelrx-announces-fda-approval-dsuviatm
2. https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM622858.pdf
3. https://consumer.healthday.com/bone-and-joint-information-4/opioids-990/fda-approves-powerful-new-opioid-despite-criticisms-739347.html

Author

Rajaneesh K. Gopinath