Vertex Pharmaceuticals Secures FDA Approval for JOURNAVX, a Non-Opioid Pain Treatment

• The FDA has approved Vertex Pharmaceuticals’ JOURNAVX (suzetrigine), a non-opioid pain signal inhibitor, for adults with moderate-to-severe acute pain.

• JOURNAVX is the first new class of pain medicine approved in more than 20 years, offering effective relief without evidence of addictive potential.

The U.S. Food and Drug Administration (FDA) has approved Vertex Pharmaceuticals’ JOURNAVX (suzetrigine), a non-opioid, highly selective NaV1.8 pain signal inhibitor, for the treatment of adults with moderate-to-severe acute pain. The approval marks the first new class of pain medicine introduced in more than two decades.

JOURNAVX is designed to provide effective pain relief with a favourable safety profile and no evidence of addictive potential. It is indicated for use across all types of moderate-to-severe acute pain, addressing a critical need for non-opioid treatment options.

“Today’s approval is a historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “With the approval of JOURNAVX, a non-opioid, pain signal inhibitor and the first new class of pain medicine approved in more than 20 years, we have the opportunity to change the paradigm of acute pain management and establish a new standard of care.”

JOURNAVX could provide an alternative to opioid-based pain treatments, which have been associated with addiction risks. Jessica Oswald, M.D., M.P.H., a member of Vertex’s Acute Pain Steering Committee, noted that the approval represents a significant step forward for both patients and physicians. “I believe JOURNAVX could redefine the management of pain and become a foundational treatment option for people with all types of moderate-to-severe acute pain, where options aside from opioids have been so desperately needed,” she said.