Skip to Content Facebook Feature Image

Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain

News

Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain
News

News

Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain

2025-01-31 07:25 Last Updated At:07:41

BOSTON--(BUSINESS WIRE)--Jan 30, 2025--

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved JOURNAVX™ (suzetrigine), an oral, non-opioid, highly selective NaV1.8 pain signal inhibitor for the treatment of adults with moderate-to-severe acute pain. JOURNAVX is an effective, well-tolerated medicine without evidence of addictive potential indicated for use across all types of moderate-to-severe acute pain.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250109747971/en/

“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.”

“This is an incredible day for patients and physicians alike who now have an approved non-opioid treatment that delivers effective acute pain relief and a favorable safety profile without addictive potential,” said Jessica Oswald, M.D., M.P.H., Associate Physician in Emergency Medicine and Pain Medicine in San Diego and Vertex Acute Pain Steering Committee Member. “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.”

As part of Vertex’s ongoing commitment to patients, the company has established patient support programs to help ensure that qualified patients can access JOURNAVX. For more information visit JOURNAVX.com.

About Acute Pain

Acute pain is a serious and potentially disabling condition often caused by surgery, accident or injury. Over 80 million Americans are prescribed medicine to treat their moderate-to-severe acute pain every year. Of these, about 40 million are prescribed an opioid. Nearly 10% of acute pain patients treated initially with an opioid will go on to have prolonged opioid use, and about 85,000 patients will develop opioid use disorder annually. Poorly controlled acute pain can lead to reduced quality of life, development of chronic pain, and increased burden on the health care system and society.

About JOURNAVX™ (suzetrigine)

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 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. Vertex has established a wholesale acquisition cost for JOURNAVX in the United States of $15.50 per 50mg pill.

Vertex is also evaluating suzetrigine in peripheral neuropathic pain (PNP). The company’s Phase 3 pivotal program for suzetrigine in patients with painful diabetic peripheral neuropathy is ongoing, and Vertex plans to advance its pivotal program evaluating suzetrigine in patients with painful lumbosacral radiculopathy pending discussions with regulators.

INDICATION and IMPORTANT SAFETY INFORMATION FOR JOURNAVX ™ (suzetrigine)

INDICATION AND USAGE

JOURNAVX is a prescription medicine used to treat adults with moderate-to-severe short term (acute) 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. People with liver problems may have an increased risk of getting side effects from taking JOURNAVX; are pregnant or plan to become pregnant as it is not known if JOURNAVX will harm an unborn baby. Patients and their healthcare providers should decide if they will take JOURNAVX while they are pregnant, are breastfeeding, or are planning to breastfeed, as it is not known if JOURNAVX passes into breast milk. Patients and their healthcare providers should decide if they will take JOURNAVX while they are breastfeeding.

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. If they take one of these contraceptives (progestins other than levonorgestrel or norethindrone), 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 with JOURNAVX 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 know the medicines they take and keep a list of them to show their healthcare provider and pharmacist when they get a new medicine. Patients should not take food or drink containing grapefruit while taking JOURNAVX.

JOURNAVX can cause side effects: The most common side effects for patients treated with JOURNAVX include itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. JOURNAVX may temporarily reduce the chance of females becoming pregnant while on treatment. Patients should talk to their healthcare provider if they have concerns about becoming pregnant. If patients are using contraceptives, continue to use contraceptives during treatment with JOURNAVX. 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 click here for the 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. The company has approved medicines that treat the underlying causes of multiple serious diseases and conditions — cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain — and 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 neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes 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 15 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 Reshma Kewalramani, M.D., and Jessica Oswald, M.D., M.P.H., in this press release and statements regarding the expectations for the potential benefits of JOURNAVX, expectations that JOURNAVX provides pain relief without the limitations of currently available therapies, including the addictive potential of opioids, expectations for the eligible patient population, plans for and status of our clinical trials evaluating suzetrigine in diabetic peripheral neuropathy, and plans to advance the pivotal program evaluating suzetrigine in patients with painful lumbosacral radiculopathy pending discussions with regulators. 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 development programs may not support registration or further development of its compounds due to safety, efficacy or other reasons, and other risks listed under the heading “Risk Factors” in Vertex's annual report and in subsequent filings filed with the Securities and Exchange Commission and available through the company's website at www.vrtx.com and www.sec.gov. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

JOURNAVX logo (Graphic: Business Wire)

JOURNAVX logo (Graphic: Business Wire)

JOURNAVX bottle and tablet (Photo: Business Wire)

JOURNAVX bottle and tablet (Photo: Business Wire)

A group of Buddhist monks and their rescue dog are striding single file down country roads and highways across the South, captivating Americans nationwide and inspiring droves of locals to greet them along their route.

In their flowing saffron and ocher robes, the men are walking for peace. It's a meditative tradition more common in South Asian countries, and it's resonating now in the U.S., seemingly as a welcome respite from the conflict, trauma and politics dividing the nation.

Their journey began Oct. 26, 2025, at a Vietnamese Buddhist temple in Texas, and is scheduled to end in mid-February in Washington, D.C., where they will ask Congress to recognize Buddha’s day of birth and enlightenment as a federal holiday. Beyond promoting peace, their highest priority is connecting with people along the way.

“My hope is, when this walk ends, the people we met will continue practicing mindfulness and find peace,” said the Venerable Bhikkhu Pannakara, the group’s soft-spoken leader who is making the trek barefoot. He teaches about mindfulness, forgiveness and healing at every stop.

Preferring to sleep each night in tents pitched outdoors, the monks have been surprised to see their message transcend ideologies, drawing huge crowds into churchyards, city halls and town squares across six states. Documenting their journey on social media, they — and their dog, Aloka — have racked up millions of followers online. On Saturday, thousands thronged in Columbia, South Carolina, where the monks chanted on the steps of the State House and received a proclamation from the city's mayor, Daniel Rickenmann.

At their stop Thursday in Saluda, South Carolina, Audrie Pearce joined the crowd lining Main Street. She had driven four hours from her village of Little River, and teared up as Pannakara handed her a flower.

“There’s something traumatic and heart-wrenching happening in our country every day,” said Pearce, who describes herself as spiritual, but not religious. “I looked into their eyes and I saw peace. They’re putting their bodies through such physical torture and yet they radiate peace.”

Hailing from Theravada Buddhist monasteries across the globe, the 19 monks began their 2,300 mile (3,700 kilometer) trek at the Huong Dao Vipassana Bhavana Center in Fort Worth.

Their journey has not been without peril. On Nov. 19, as the monks were walking along U.S. Highway 90 near Dayton, Texas, their escort vehicle was hit by a distracted truck driver, injuring two monks. One of them lost his leg, reducing the group to 18.

This is Pannakara's first trek in the U.S., but he's walked across several South Asian countries, including a 112-day journey across India in 2022 where he first encountered Aloka, an Indian Pariah dog whose name means divine light in Sanskrit.

Then a stray, the dog followed him and other monks from Kolkata in eastern India all the way to the Nepal border. At one point, he fell critically ill and Pannakara scooped him up in his arms and cared for him until he recovered. Now, Aloka inspires him to keep going when he feels like giving up.

“I named him light because I want him to find the light of wisdom,” Pannakara said.

The monk's feet are now heavily bandaged because he's stepped on rocks, nails and glass along the way. His practice of mindfulness keeps him joyful despite the pain from these injuries, he said.

Still, traversing the southeast United States has presented unique challenges, and pounding pavement day after day has been brutal.

“In India, we can do shortcuts through paddy fields and farms, but we can’t do that here because there are a lot of private properties,” Pannakara said. “But what’s made it beautiful is how people have welcomed and hosted us in spite of not knowing who we are and what we believe.”

In Opelika, Alabama, the Rev. Patrick Hitchman-Craig hosted the monks on Christmas night at his United Methodist congregation.

He expected to see a small crowd, but about 1,000 people showed up, creating the feel of a block party. The monks seemed like the Magi, he said, appearing on Christ’s birthday.

“Anyone who is working for peace in the world in a way that is public and sacrificial is standing close to the heart of Jesus, whether or not they share our tradition,” said Hitchman-Craig. “I was blown away by the number of people and the diversity of who showed up.”

After their night on the church lawn, the monks arrived the next afternoon at the Collins Farm in Cusseta, Alabama. Judy Collins Allen, whose father and brother run the farm, said about 200 people came to meet the monks — the biggest gathering she’s ever witnessed there.

“There was a calm, warmth and sense of community among people who had not met each other before and that was so special,” she said.

Long Si Dong, a spokesperson for the Fort Worth temple, said the monks, when they arrive in Washington, plan to seek recognition of Vesak, the day which marks the birth and enlightenment of the Buddha, as a national holiday.

“Doing so would acknowledge Vesak as a day of reflection, compassion and unity for all people regardless of faith,” he said.

But Pannakara emphasized that their main goal is to help people achieve peace in their lives. The trek is also a separate endeavor from a $200 million campaign to build towering monuments on the temple’s 14-acre property to house the Buddha’s teachings engraved in stone, according to Dong.

The monks practice and teach Vipassana meditation, an ancient Indian technique taught by the Buddha himself as core for attaining enlightenment. It focuses on the mind-body connection — observing breath and physical sensations to understand reality, impermanence and suffering. Some of the monks, including Pannakara, walk barefoot to feel the ground directly and be present in the moment.

Pannakara has told the gathered crowds that they don't aim to convert people to Buddhism.

Brooke Schedneck, professor of religion at Rhodes College in Memphis, Tennessee, said the tradition of a peace walk in Theravada Buddhism began in the 1990s when the Venerable Maha Ghosananda, a Cambodian monk, led marches across war-torn areas riddled with landmines to foster national healing after civil war and genocide in his country.

“These walks really inspire people and inspire faith,” Schedneck said. “The core intention is to have others watch and be inspired, not so much through words, but through how they are willing to make this sacrifice by walking and being visible.”

On Thursday, Becki Gable drove nearly 400 miles (about 640 kilometers) from Cullman, Alabama, to catch up with them in Saluda. Raised Methodist, Gable said she wanted some release from the pain of losing her daughter and parents.

“I just felt in my heart that this would help me have peace,” she said. “Maybe I could move a little bit forward in my life.”

Gable says she has already taken one of Pannakara’s teachings to heart. She’s promised herself that each morning, as soon as she awakes, she’d take a piece of paper and write five words on it, just as the monk prescribed.

“Today is my peaceful day.”

Freelance photojournalist Allison Joyce contributed to this report.

Associated Press religion coverage receives support through the AP’s collaboration with The Conversation US, with funding from Lilly Endowment Inc. The AP is solely responsible for this content.

Buddhist monks who are participating in the, "Walk For Peace," get lunch Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Buddhist monks who are participating in the, "Walk For Peace," get lunch Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Aloka rests with Buddhist monks who are participating in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Aloka rests with Buddhist monks who are participating in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

A sign is seen greeting the Buddhist monks who are participating in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

A sign is seen greeting the Buddhist monks who are participating in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Supporters pray with Buddhist monks who are participating in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Supporters pray with Buddhist monks who are participating in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Supporters watch Buddhist monks who are participating in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Supporters watch Buddhist monks who are participating in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

A Buddhist monk ties a prayer bracelet around the wrist of Josey Lee, 2-months-old, during the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

A Buddhist monk ties a prayer bracelet around the wrist of Josey Lee, 2-months-old, during the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Bhikkhu Pannakara, a spiritual leader, speaks to supporters during the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Bhikkhu Pannakara, a spiritual leader, speaks to supporters during the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Buddhist monks participate in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Buddhist monks participate in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Buddhist monks participate in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Buddhist monks participate in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Bhikkhu Pannakara leads other buddhist monks in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Bhikkhu Pannakara leads other buddhist monks in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Audrie Pearce greets Buddhist monks who are participating in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Audrie Pearce greets Buddhist monks who are participating in the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Bhikkhu Pannakara, a spiritual leader, speaks to supporters during the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Bhikkhu Pannakara, a spiritual leader, speaks to supporters during the, "Walk For Peace," Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Buddhist monks who are participating in the, "Walk For Peace," arrive in Saluda, Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Buddhist monks who are participating in the, "Walk For Peace," arrive in Saluda, Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Buddhist monks who are participating in the, "Walk For Peace," are seen with their dog, Aloka, Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Buddhist monks who are participating in the, "Walk For Peace," are seen with their dog, Aloka, Thursday, Jan. 8, 2026, in Saluda, S.C. (AP Photo/Allison Joyce)

Recommended Articles