FDA approves Vertex’s first-in-class, non-opioid medication for acute pain
Thursday’s approval of Boston-based Vertex Pharmaceuticals’ Journavx (suzetrigine) — the first new class of pain medication to be approved in more than 20 years — introduces a novel approach to treating acute pain that could revolutionize pain management.
Journavx is an oral, non-opioid analgesic that targets a pain-signaling pathway in the peripheral nervous system, preventing pain-conducting nerves at the site of tissue damage from firing and carrying electrical signals to the brain.
Opioids, by contrast, work by dulling the sensation of pain in the brain.
Approved for twice-daily use in adults with moderate to severe acute pain, Journavx shows no evidence of addictive potential, Vertex noted in a news release. It does not create the “high” commonly associated with opioid medications, nor does it cause drowsiness or nausea, as opioids sometimes do.
“With the approval of Journavx … we have the opportunity to change the paradigm of acute pain management and establish a new standard of care,” said Dr. Reshma Kewalramani, Vertex’s CEO.
“Today’s approval is an important public health milestone in acute pain management,” said Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research. “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option.”
Journavx was evaluated in two large clinical trials of patients who had undergone relatively minor surgeries. The participants were randomized to receive Journavx, placebo, or the often-prescribed combination opioid hydrocodone and acetaminophen. Ibuprofen was permitted as a rescue pain medication.
Although the trials were not designed to directly compare Journavx and the combination pain reliever, similar numbers of participants in both groups said the medications reduced their pain by at least half. Both medications controlled pain better than placebo did.
The most common adverse reactions reported by those treated with Journavx were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash.
Vertex priced Journavx at $11.50 per 50 mg tablet. The company said it has established patient support programs to help ensure those who qualify for treatment can access the drug.
OUR TAKE: The price of Journavx may limit uptake of the drug — at least initially, until it’s known whether insurers will cover it. Opioid painkillers are far less expensive, but for those at risk for addiction, the difference in cost may well be worth it, particularly for short-term use after surgery.
Vertex is evaluating suzetrigine as a potential treatment for chronic and long-term pain, including diabetic peripheral neuropathy and back pain caused by sciatica. So far, the results have been mixed.
The company reported positive results in December 2023 from a Phase II dose-ranging study of the drug in patients with diabetic peripheral neuropathy, with all doses leading to a statistically significant and clinically meaningful reduction in the primary endpoint of change from baseline in the weekly average of daily pain intensity on a numeric pain rating scale (NPRS) at week 12. Vertex has advanced the development program to Phase III.
Results from a Phase II trial of suzetrigine in patients with painful lumbosacral radiculopathy reported in December 2024 showed that the study met its primary endpoint, with the suzetrigine arm showing a statistically significant and clinically meaningful within-group reduction from baseline in the weekly average of daily leg pain intensity on the NPRS at week 12. The placebo arm, however, showed a similar within-group reduction from baseline in pain at week 12.
Post hoc analyses suggested the similar responses observed in the suzetrigine and placebo arms may have been due to a high placebo response, Vertex noted. The company plans to adapt its Phase III study design to control for the placebo effect.
Vertex received another FDA approval in December for Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class cystic fibrosis transmembrane conductance regulator modulator for the treatment of cystic fibrosis in patients with a certain gene mutation.
Disclosure: Vertex Pharmaceuticals is a Darwin Research Group client.
What else you need to know
Duluth, Minn.-based Essentia Health and the University of Minnesota have proposed a framework for creating a new not-for-profit entity that might also include other partners of the two organizations. The resulting entity, they said in a news release, would address Minnesota’s most urgent health care needs in new ways while ensuring the future of academic medicine in the state, as well as essential financial support for the university’s medical school. The organizations said they have shared their vision for “an ‘all-Minnesota’ health solution” with Fairview Health Services — the university currently operates under a collaborative agreement with Fairview that ends in 2026.
Dr. David Herman, Essentia’s CEO, said in the release, “Essentia Health has a long and committed partnership with the University of Minnesota. With nearly 70% of all Minnesota physicians having been trained at the university, we know that continuing to deliver excellent patient outcomes while building a sustainable health care future rests on the foundation of a strong medical school. These are key reasons why Essentia leadership has begun exploring opportunities to build a new framework for health care in Minnesota.”
The proposed entity would invest up to $1 billion over a five-year period to achieve its vision for Minnesota’s health care, according to the release. Essentia Health has 14 hospitals, 78 clinics, and a research institute, among other facilities; it also serves patients in North Dakota and Wisconsin.
Montefiore Health System is the latest to partner with Amazon One Medical in a broad effort to expand access to primary and specialty care. According to the announcement, One Medical will open its first primary care offices through the collaboration with Montefiore in New York’s Westchester County in 2026, with additional facilities in other locations to follow over a period of several years. One Medical members will have access to same- and next-day appointments, onsite lab services, and virtual care. “Our collaboration with Amazon One Medical will enhance primary care offerings across the communities we serve and ensure those with needs for specialty care have the option to be seen and treated by our world-renowned clinicians,” said Dr. Philip Ozuah, CEO of Montefiore Einstein. One Medical has primary and/or specialty care partnerships with approximately 20 large health systems across the country.
Deaconess Health System, Emory Healthcare, Johns Hopkins Medicine, Mayo Clinic, and UChicago Medicine are among the early adopters of a new generative AI product Pittsburgh-based Abridge designed in collaboration with emergency department clinicians specifically for emergency care. Launched officially last week, Abridge Inside for Emergency Medicine features seamless integration with Epic’s ASAP module in Haiku and Hyperspace, according to Abridge’s press release. The ambient note-taking tool detects medical specialties, languages, and multiple speakers without requiring manual setting adjustments and was developed to address the ED’s fast-paced, chaotic environment and discontinuous workflow.
Citing a 2024 Medscape survey, Abridge noted that emergency medicine clinicians experience the highest rate of burnout of any specialty, at 63%. Dr. Tricia Smith, an attending emergency physician at Emory University Hospital Midtown, said Abridge Inside has reduced burnout and increased job satisfaction in the ED there without any other changes. “We have adopted one technology that has really impacted our work and, therefore, our patients — and I can’t think of a single person who uses Abridge who would go back,” she said.
Walgreens Boots Alliance’s stock price took a couple of hits again last week. The first drop occurred early in the week when media outlets reported that a potential buyout arrangement with private equity firm Sycamore Partners was “mostly dead.” The stock plummeted again on Friday after the pharmacy chain suspended its quarterly dividend for the first time in 92 years. Walgreens’ board of directors made the decision not to pay the dividend in an attempt to strengthen the company’s balance sheet and improve free cash flow, according to a statement. “The company’s cash needs over the next several years, including with respect to litigation and debt refinancing, were important considerations as part of the decision to suspend the dividend,” the statement noted. Walgreens’ shares have lost more than half their value in the past year.
In separate news, Advocate Health Care will close all 55 clinics it operates in Walgreens stores in two states: 47 clinics in Illinois and the eight clinics Aurora Health Care began operating in Wisconsin in 2017 before merging with Advocate Health. The closures will take effect on Feb. 6. Advocate Health Care said in a statement that closing the clinics will allow the health system “to focus on additional ways patients prefer to access care, when and where they need it.”
The FDA approved Novo Nordisk’s Ozempic (semaglutide) to reduce the risk of worsening kidney disease and cardiovascular health in adults with type 2 diabetes and chronic kidney disease. The approval was based on results from a Phase IIIb clinical trial in which Ozempic demonstrated a statistically significant 24% relative risk reduction of kidney disease worsening, kidney failure, and death due to cardiovascular disease when added to standard of care, compared with placebo. The GLP-1 receptor agonist is also indicated to improve glycemic control in adults with type 2 diabetes and to reduce major cardiovascular events in adults with type 2 diabetes and known heart disease.
What we’re reading
A Critical Deficit. Open Mind, 1.30.25
The Return of Snake Oil. The Atlantic, 1.30.25
