BOSTON, MA — Vertex Pharmaceuticals announced that the FDA has accepted its New Drug Application (NDA) submission for suzetrigine, an investigational, oral, selective NaV1.8 pain signal inhibitor to treat moderate-to-severe acute pain. 

The FDA granted suzetrigine priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025January 30, 2025. Suzetrigine has already been granted FDA Fast Track and Breakthrough Therapy designations for the treatment of moderate-to-severe acute pain.

“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 U.S.,” said Nia Tatsis, Ph.D., Executive Vice President, Chief Regulatory and Quality Officer at Vertex. “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.”

"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, M.D., M.P.H., 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."

Suzetrigine (formerly VX-548) is an investigational oral, selective NaV1.8 pain signal inhibitor that is highly selective for NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated sodium channel that is selectively expressed in peripheral pain-sensing neurons (nociceptors), where its role is to transmit pain signals (action potentials). NaV1.8 is a genetically validated target for the treatment of pain, and suzetrigine has demonstrated a favorable benefit/risk profile in three Phase 3 studies and two Phase 2 studies in patients with moderate-to-severe acute pain. Suzetrigine also demonstrated positive results and a well-tolerated profile in a Phase 2 study in patients with pain associated with diabetic peripheral neuropathy, a type of chronic peripheral neuropathic pain. Vertex’s approach is to selectively inhibit NaV1.8 using small molecules with the objective of creating a new class of pain signal inhibitors that have the potential to provide effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids.