FDA Approves Dsuvia for Acute Pain Management
Today, the FDA announced the approval of Dsuvia for the management of acute pain in adults that is severe enough to require an opioid analgesic in medically supervised settings, according to a press release.
Dsuvia (sufentanil sublingual tablet, 30 mcg, AcelRx Pharmaceuticals Inc.) is a single-dose tablet with a pre-filled applicator for under-the-tongue administration by a health care professional, according to the release.
“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,” Pamela Palmer, MD, PhD, co-founder and chief medical officer of AcelRx, said in the release. “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.”
The FDA approval was based on results from a randomized, double-blind, placebo-controlled clinical study in which sufentanil sublingual tablet showed statistically greater summed pain intensity difference from baseline during the first 12 hours compared to placebo, according to the release. Additionally, sufentanil sublingual tablet demonstrated superiority regarding pain intensity difference from baseline to 15 minutes compared to placebo, according to the release. A single dose of the tablet also had superior median meaningful pain relief, according to the release.
Sufentanil sublingual tablet was designed as a single-strength tablet with single-unit packaging to reduce the potential for dosing errors, misuse and diversion, according to the release. The under-the-tongue administration route allows the tablet to be an option for patients with nothing-by-mouth status and patients with difficult IV access, including obese, elderly and burn or needle-phobic patients, according to the release. Eliminating the need for an IV may improve efficiency and patient experience, according to the release.
“Managing acute pain is critical to a patient’s recovery process, especially in the postoperative setting, but current oral and IV opioid analgesics can be slow-acting and challenging to dose and administer, which in turn can limit optimal pain relief and even be dangerous to patients,” David Leiman, MD, clinical assistant professor of surgery at the University of Texas at Houston and director of HD Research, said in the release. “As a single-dose, non-invasive medication with a rapid reduction in pain intensity, Dsuvia represents an important alternative for health care providers to offer patients for acute pain management.”
AcelRx expects to commercially launch sufentanil sublingual tablet in the first quarter of 2019.
On Oct. 12, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee held a meeting to vote on sufentanil sublingual tablet’s recommendation of approval. During the meeting, several committee members cited concerns about ensuring that the drug would only be administered in hospitals by trained medical employees, but ultimately voted 10-3, stating the benefits of the tablet outweigh the risks.
“There are very tight restrictions being placed on the distribution and use of this product.” Scott Gottlieb, MD, commissioner of FDA, said in a separate press release about the approval. “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.”
Disclosure: Healio Internal Medicine was unable to confirm relevant financial disclosures at the time of publication.