The U.S. Food and Drug Administration (FDA)’s Anesthetic and Analgesic Drug Products Advisory Committee voted to recommend AcelRx Pharmaceuticals’ Dsuvia to manage moderate-to-severe pain.

The advisory committee (adcom) voted 10 to 3 in favor of the drug, which is a sublingual tablet formulation of sufentanil, an opioid marketed for intravenous (IV) and epidural anesthesia and analgesia. The company markets Dsuvia outside the U.S. as Dzuveo. The FDA’s adcom recommended the drug for moderate-to-severe pain in medically supervised settings for adults.

Dsuvia was developed as an easy-to-administer dosage for pain relief as early as 15 minutes. The FDA’s target action date is November 3, 2018. The drug was approved as Dzuveo by the European Medicines Agency (EMA) in June 2018. Although the agency is not required to follow the adcom’s recommendations, it usually does.

“We are pleased with the Advisory Committee’s recommendation to approve Dsuvia as a treatment in medically supervised settings for adults experience moderate-to-severe acute pain,” said Pamela Palmer, AcelRx’ co-founder and chief medical officer, in a statement. “We look forward to continued collaboration with the FDA on the application as we believe Dsuvia represents an important non-invasive acute pain management option with potential to significantly improve the current standard of care.”

Dsuvia’s development was partially funded by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC). The CRMRP was created in 2008 to encourage research and technological advances for regeneration, restoration, and rehabilitation of traumatic injuries.

The FDA had rejected AcelRx’s original application for Dsuvia in 2017, requesting more safety and efficacy data, as well as more instructions on its use.

At the adcom hearing on Friday, October 12, Palmer stated the drug “has a predictable onset of action of 15 to 30 minutes without the delay of starting an IV. The 24-hour average redosing interval was 3.07 hours. Dsuvia does not have any active metabolites.”

She went on to say, “Importantly, the safety and efficacy of Dsuvia in non-opioid tolerant patients was demonstrated across the clinical program and had a safety profile similar to other opioids. With our educational and REMS materials in place, and limiting Dsuvia to medically-supervised settings, where it will be administered by trained medical providers, we believe the benefits of Dsuvia outweigh the risks.”

The company is sensitive to the current concerns over opioids. In an interview prior to the adcom meeting, company chief executive officer Vince Angotti told Healio Family Medicine, “We are not, and we will never be, a chronic pain company. You will not see Dsuvia in someone’s medicine cabinet. Dsuvia is only for supervised hospital settings and emergency situations like shoulder separations, long bone fracture, burn or other emergency room visit. This is not a drug for things like lower back pain. The goal here is not to expand opioid use.”

Much of the adcom’s expressed concerns were of the potential for abuse or even use outside the medically supervised setting. For example, two of the committee members, Steven B. Meisel, director of medication safety at Fairview Health Services in Minnesota and Terri L. Warholak, professor and assistant dean of the college of pharmacy at the University of Arizona, questioned AcelRx representatives at the meeting for more details about how the company could ensure that it will only be used by trained medical staffers.

Palmer indicated they were going to make single dose applicators with placebos available for training purposes and provide in-service hospital training to institutions that request it. If the hospitals prefer to do their own training, the company would provide training materials. “The key thing,” Palmer said, “is that the hospital must document the training because we will be auditing for that.”