FDA accepts NDA for Vertex’s non-opioid pain drug

On July 30, 2024, Vertex Pharmaceutical announced that the United States Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for suzetrigine, a non-opioid pain signal inhibitor for managing moderate-to-severe acute pain. The application has also been granted Priority Review, Fast Track, and Breakthrough Therapy designations.

“Today’s FDA filing acceptance for suzetrigine marks a critical milestone toward bringing this new, transformative non-opioid analgesic to the millions of patients suffering from moderate-to-severe acute pain each year in the US,” said Nia Tatsis, PhD, Executive Vice President, Chief Regulatory and Quality Officer at Vertex, in the press release.

“The FDA’s granting of a priority review further reinforces the high unmet need in treating acute pain, and the filing brings us one step closer to our objective of filling the gap between medicines with good tolerability but limited efficacy and opioid medicines with therapeutic efficacy but known risks, including addictive potential.”

Suzetrigine, previously called VX-548, is an investigative NaV1.8 pain signal inhibitor that is highly selective and primarily inhibits NaV1.8 voltage-gated sodium channels. These channels are expressed on peripheral pain-sensing neurons and transmit pain signals.

According to the press release, multiple phase 2 and 3 clinical studies have genetically validated NaV1.8 as a target for pain management with a promising benefit/risk profile. In phase 2 clinical studies, suzetrigine safely managed pain in patients with diabetic peripheral neuropathy.

Vertex claims that this drug could be the first new class of acute pain management medications in two decades.

"In my 24 years practicing medicine, I have seen firsthand the desperate need for new non-opioid therapies for treating pain. Too many people today are either undertreated, dealing with negative side effects of currently available therapies, or foregoing pain medications altogether for fear of becoming dependent on opioids,” said Scott Weiner, MD, MPH, Vertex Acute Pain Steering Committee Chair, Associate Professor of Emergency Medicine at Harvard Medical School and Attending Emergency Physician in the Department of Emergency Medicine at Brigham and Women’s Hospital. “Prescribers and patients deserve new options."