The First New Pain Class in Twenty Years
Vertex spent over a decade discovering a non-opioid painkiller. The hard part is what comes next: Reshma Kewalramani must sell JOURNAVX against cheap opioids and cautious insurers.
On January 30, 2025, the U.S. Food and Drug Administration approved a medicine no company had brought to market in more than twenty years: JOURNAVX, an oral, non-opioid pain signal inhibitor and the first of a new class. For Reshma Kewalramani, president and chief executive officer of Vertex Pharmaceuticals, the approval was the payoff on a program she had inherited in the pipeline, not started - and the company's first approved medicine outside cystic fibrosis, the rare-disease franchise that had built it.
Kewalramani put the stakes in terms of scale rather than chemistry: "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."
A Launch, Not A Discovery
The molecule predated her arrival in the corner office. Kewalramani trained as a physician and nephrologist - an internal medicine residency at Massachusetts General Hospital, a nephrology fellowship at MGH and Brigham and Women's - before moving into drug development. She spent more than twelve years at Amgen, joined Vertex in February 2017 as chief medical officer and head of global medicines development, and became chief executive on April 1, 2020, succeeding Jeffrey Leiden. When the board named her, she cast the job as continuity of a plan already running, saying she was "honored to become Vertex's next CEO and to continue to work alongside Jeff, the Board and our leadership team" as the company entered its next phase.
Beyond Cystic Fibrosis
For most of its history Vertex was a one-disease company: cystic fibrosis, treated by a franchise that funded everything else. JOURNAVX was the proof that the research engine could produce a first-in-class medicine in a second area entirely. Kewalramani had cast the approval as a chance to change "the paradigm of acute pain management", delivering what she called "the first new class of pain medicine approved in more than 20 years".
Matched, Not Beaten
The data that won approval carried the complication inside it. Across two Phase 3 trials - one after abdominoplasty, one after bunionectomy - suzetrigine beat placebo on the primary endpoint. But on the key secondary endpoint, the head-to-head against an opioid comparator of hydrocodone and acetaminophen, it did not win. The trial publication stated it plainly: "Pain reduction with suzetrigine was similar to that with hydrocodone bitartrate/acetaminophen." A non-opioid that matched an opioid, without addictive potential, was a real advance; a non-opioid that had beaten one outright would have been a larger one, and investors who wanted superiority marked the gap.
Kewalramani's task now is commercial, not scientific: turning a first-in-class approval into prescriptions against cheap generic opioids and a cautious payer system, while the same molecule is tested in diabetic nerve pain and, pending regulators, in lower-back pain, where the bar sits higher still. The discovery is behind her. The launch is hers to prove.