The FDA last week approved AcelRx‘s (NSDQ:ACRX) Dsuvia sufentanil product, noting that use of the opioid will be tightly restricted to adults experiencing acute pain in medically-supervised healthcare settings.
Dsuvia is a tablet that is administered sublingually in a single-dose, pre-filled applicator. The company expects to launch its pain product in the first quarter of 2019.
“The FDA approval of Dsuvia is the culmination of nearly 15 years of research to improve the standard of care for managing acute pain in medically supervised settings,” co-founder & CMO Dr. Pamela Palmer said in prepared remarks. “As an anesthesiologist, I’ve seen the challenges that IV opioids pose to patients and providers, such as logistical delays in initiating IV lines, difficulty in accessing veins, and medication errors with injectable opioids. AcelRx was founded to develop a simple, effective, non-invasive analgesic option to enable healthcare professionals to rapidly manage their patients’ acute pain.”
“The approval of Dsuvia, which was developed in collaboration with the Department of Defense, underscores our commitment to provide innovative therapies for use in medically supervised settings,” CEO Vince Angotti added.
In a rare move, FDA chief Dr. Scott Gottlieb issued a statement explaining Dsuvia’s approval. He wrote that the Pentagon saw this product as a priority and that the agency worked closely with AcelRx to push the product through development.
Gottlieb also pointed out that the distribution and use of Dsuvia will be tightly restricted.
“We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia, including requiring a Risk Evaluation and Mitigation Strategy (REMS) to accompany this drug. The REMS reflects the potential risks associated with this product and will tightly control its distribution and use. Importantly, the distribution system will restrict Dsuvia’s use to certified medically-supervised health care settings, an important step to help prevent misuse and abuse of Dsuvia. The FDA will continue to carefully monitor the implementation of the REMS associated with Dsuvia and compliance with its requirements, and we’ll work to quickly make regulatory adjustments if problems arise,” he said.
“We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings. We are committed to the safe and effective administration of Dsuvia through diligent adherence to our FDA-approved Risk Evaluation and Mitigation Strategies program,” Angotti said.
Gottlieb also discussed how the FDA plans to review new formulations of opioids moving forward, writing that he wonders to what extent each new opioid should be evaluated solely on its own merits or within the broader landscape of public health.
The FDA is reportedly evaluating a new framework for opioid analgesic approvals that would clarify how the agency balances the benefits and risks of opioid products in the context of the ongoing opioid crisis.
“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.