Vertex to Present New Data on JOURNAVX® That Demonstrates Effective Pain Management Following Aesthetic and Reconstructive Procedures

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Key Terms

phase 4 medical

Phase 4 is the stage after a drug or vaccine has been approved and is sold to the public, where regulators and companies keep watching how it performs in the real world to detect rare side effects, long‑term effects, or differences in effectiveness across different groups. Think of it as ongoing quality control for a product already on shelves; results can prompt label changes, safety warnings, sales impacts or recalls, all of which matter to investors evaluating risk and future revenue.

open-label medical

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

multicenter medical

A multicenter study or trial is conducted at several independent locations or clinics rather than a single site, so researchers collect data from diverse groups and settings. For investors, multicenter designs matter because they increase the credibility and generalizability of results, reduce the risk that findings are due to one local population or practice, and often speed enrollment — all factors that can affect regulatory outcomes, market confidence and commercial prospects.

single-arm medical

A single-arm study is a clinical trial that gives all participants the same treatment and does not include a separate comparison group or placebo. Think of it like testing a new recipe by serving it to diners without offering a control dish — you can see how people respond, but you can’t directly compare results to another option. For investors, single-arm trials can speed development and reduce cost but leave more uncertainty about how a treatment stacks up against existing therapies and how regulators will view the evidence.

multimodal therapy medical

Multimodal therapy is a medical approach that combines two or more types of treatment—such as drugs, surgery, radiation, or behavioral therapy—to attack a disease from different angles. For investors, it signals more complex development, potentially larger clinical benefits and costs, and different regulatory and reimbursement paths; think of it like a team sport where coordinated players can outperform a solo player but require more planning, resources and coordination to succeed.

rescue opioids medical

Rescue opioids are fast-acting pain medicines given for sudden, severe flare-ups of pain when a patient’s regular pain control isn’t enough—think of them as an emergency relief dose, like a spare tire you use briefly when a flat tire appears. For investors, they matter because demand, pricing, safety profiles, and regulation for these short-acting drugs can affect a drug maker’s sales, liability risk, and market access, especially given heightened scrutiny around addiction and prescribing rules.

adverse events medical

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

postoperative medical

The period after a surgical operation when the patient is recovering and receiving follow-up care, monitoring, pain control, wound management and any needed interventions for complications. Investors watch postoperative outcomes because recovery time, complication rates and follow-up treatments drive healthcare costs, demand for medical devices and drugs, reimbursement levels and liability risks—similar to how the quality of repairs and follow-up service affect a car’s long-term performance and resale value.

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03/05/2026 - 10:00 AM

-Over 90% of patients in the study were opioid free through the end of multimodal treatment with JOURNAVX-

-These data have been accepted for oral presentation at the American Academy of Pain Medicine Meeting-

BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data from a Phase 4 study of JOURNAVX^® (suzetrigine), a prescription non-opioid pain signal inhibitor for the treatment of moderate-to-severe acute pain, in adults, that demonstrated effective pain management and enabled opioid-free recovery after a broad range of plastic surgical procedures. These data showed that the majority of patients (90.9%) in the study were opioid free through the end of treatment (up to 14 days), demonstrating the potential for JOURNAVX as a core element of opioid-free multimodal treatment for moderate-to-severe acute pain after aesthetic and reconstructive procedures. In contrast, the literature shows opioid-free rates of less than 10% with multimodal treatment without JOURNAVX. These data will be presented at the American Academy of Pain Medicine (AAPM) PainConnect 2026 meeting, March 5-8, 2026, in Salt Lake City, UT.

This Phase 4 open-label, multicenter, single-arm study evaluated JOURNAVX when administered preoperatively and postoperatively as part of multimodal therapy, most commonly with acetaminophen and ibuprofen, in a range of reconstructive and aesthetic plastic surgeries where patients typically experience moderate-to-severe pain and are typically treated with opioid therapy for at least 72 hours postoperatively. The study dosed 99 patients who underwent aesthetic and reconstructive surgeries, including reconstructive and aesthetic breast surgeries, liposuction or abdominoplasty with liposuction, or turbinoplasties. The primary endpoint was the proportion of patients who achieved excellent, very good or good on the Patient Global Assessment scale at the end of treatment. The study showed that 90.7% of patients (95% CI: 83.1%, 95.7%) rated the effectiveness of JOURNAVX as part of multimodal treatment as excellent, very good or good. 90.9% of patients did not require any rescue opioids after surgery through the end of treatment (up to 14 days). Of the nine patients who received rescue opioids, the average use was approximately 2 tablets over 2 days.

JOURNAVX was generally safe and well tolerated with no serious adverse events related to JOURNAVX. Adverse events were mild or moderate in severity and consistent with the postoperative setting.

“As a surgeon, effective pain management is a cornerstone of patient recovery, and the data from this study highlight the potential of JOURNAVX in enabling opioid-free recovery for patients across a broad range of surgeries,” said Samuel Lin, M.D., F.A.C.S., lead author of the study; Director of Aesthetic Surgery, Beth Israel Deaconess Medical Center; Chief of Plastic Surgery, Beth Israel Deaconess Hospital—Needham; and Associate Professor of Surgery at Harvard Medical School. “By integrating JOURNAVX into a multimodal treatment approach, we are not only effectively managing pain but also potentially reducing the risks associated with opioid use, which is a critical advancement for both patients and the broader medical community.”

These data will be presented on March 6, 2026, as a poster presentation at 11:00 a.m. MT and part of the #6 Flash Talk presentation from 2:40–2:50 p.m. MT during the AAPM meeting.

If you are a health care professional and would like more information about JOURNAVX, visit www.journavxhcp.com. If you are a patient and would like more information about JOURNAVX, visit www.journavx.com.

About Journavx

JOURNAVX (suzetrigine) is a first-in-class, oral, non-opioid, highly selective pain signal inhibitor that is 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). Because JOURNAVX blocks pain signals only found in the periphery, not in the brain, JOURNAVX provides effective relief of pain without the limitations of certain currently available therapies, including the addictive potential of opioids.

The U.S. Food and Drug Administration approved twice-daily JOURNAVX for the treatment of adults with moderate-to-severe acute pain, including postoperative pain, on January 30, 2025.

JOURNAVX^®(suzetrigine) INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE

JOURNAVX is a prescription medicine used to treat adults with moderate-to-severe short-term (acute) pain, including postoperative pain.

It is not known if JOURNAVX is safe and effective in children.

IMPORTANT SAFETY INFORMATION

Patients should not take JOURNAVX if they take certain medicines that are strong inhibitors of an enzyme called CYP3A. Patients should ask their healthcare providers if they are not sure.

Before taking JOURNAVX, patients should tell their healthcare provider about all of their medical conditions, including if they: have liver problems, as people with liver problems may have an increased risk of getting side effects from taking JOURNAVX; are pregnant or plan to become pregnant, as JOURNAVX may temporarily reduce the chance of females becoming pregnant while on treatment; or are breastfeeding or planning to breastfeed.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking JOURNAVX with certain other medicines may affect the way JOURNAVX and the other medicines work and may increase patients’ risk of side effects. Patients should ask their healthcare provider or pharmacist for a list of these medicines if they are not sure.

Patients should especially tell their healthcare provider if they take hormonal birth control medicine (contraceptives) containing progestins other than levonorgestrel or norethindrone as they may not work as well during treatment with JOURNAVX. Patients should also use nonhormonal contraceptives such as condoms or use other forms of hormonal birth control during treatment and for 28 days after they stop taking JOURNAVX. Medicines that are substrates of the CYP3A enzyme may become less effective during treatment with JOURNAVX. Their healthcare provider may need to adjust the dose of patients’ medicine when starting or stopping JOURNAVX.

Patients should not take food or drink containing grapefruit while taking JOURNAVX.

The most common side effects for patients treated with JOURNAVX include itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away. These are not all of the possible side effects of JOURNAVX. Patients should call their healthcare provider for medical advice about side effects. Patients may report side effects to the FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Patient Information, for JOURNAVX.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and X.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements made by Samuel Lin, M.D., F.A.C.S., and statements regarding the clinical benefits of JOURNAVX. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's research and development programs may not support registration or further development of its potential medicines in a timely manner, or at all, due to safety, efficacy or other reasons, and other risks listed under the heading “Risk Factors” in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at www.sec.gov and available through the company's website at www.vrtx.com. You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)