The cost of treating pain in the United States is, well, painful. By one estimate, the U.S. pain therapeutics market was $17.2 billion in 2023 and is expected to rise to $26.5 billion between 2024 and 2034.
Medications help millions of people manage their short- and long-term discomfort every day. But some medications, notably opioids used by millions to manage chronic pain, have exacted a different kind of pain. For example, the bipartisan congressional Joint Economic Committee reported in 2022 that the opioid crisis, which fueled widespread addiction and hundreds of thousands of overdose deaths, cost the U.S. $1.5 trillion in 2020 alone.
Given these statistics, it’s not surprising that the FDA’s approval of suzetrigine (brand name Journavx) earlier this year caused quite a stir — particularly because it is the first new non-opioid painkiller to hit the market in more than two decades.
The new medication could be vital for patients and doctors alike since it provides an alternative to highly addictive opioid medications.
“Almost everybody experiences acute pain and unfortunately a lot of us will experience chronic pain,” said Dr. Rachael Rzasa Lynn, an interventional pain specialist and associate professor of Anesthesiology with the University of Colorado School of Medicine.
Despite the need for non-opioid medications, alternatives have been slow to come to market, until now.
“There is a huge need and yet the pipeline has been dry,” said Rzasa Lynn who cares for patients at the UCHealth Pain Management Clinic – Anschutz Medical Campus.
Rzasa Lynn answered top questions about what Journavx is and how it will work.
As a pain medicine specialist, what do you consider significant about the FDA approval of Journavx?
“It’s incredibly exciting because this is the first truly new class of oral pain medications to be approved in my lifetime,” Dr. Rzasa Lynn said. “I think the fact that people are studying very new pathways to treat pain outside of the opioid system is really exciting.”
What have been the non-opioid options for treating acute pain prior to approval of Journavx?
“Prior to this, all we’ve had are nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen, and then other drugs that have been repurposed from their original intent to treat chronic pain,” Rzasa Lynn said. Another option is anti-convulsant medications, like gabapentin, as well as some antidepressants, but neither was originally designed to address pain, she said.
What makes Journavx different from opioid medications?
First of all, it doesn’t work like opioids, which control pain by depressing the central nervous system (CNS) and slowing the transmission of pain messages to the brain. With that, opioids can trigger other changes in the brain that increase the risk of addiction. In contrast, the “target of action” for Journavx is a form of sodium channel that exists only outside the CNS, Rzasa Lynn said.
What are sodium channels and how are they involved in pain?
“Sodium channels are used in nerve cells throughout the body to transmit electrical signals,” Rzasa Lynn said. These channels are pathways of communication throughout the body, including the CNS, the peripheral nervous system, and organs, like the heart, she explained.
How are sodium channels involved in how Journavx works?
The new drug targets a very specific sodium channel – Nav1.8 – that is only located in nerve cells that send signals – including pain – to the brain, Rzasa Lynn said.
Why is it important that Journavx targets only a specific sodium channel?
Local anesthetics that numb tissue are also sodium channel blockers, Rzasa Lynn said. However, they are “non-specific,” meaning they block not one, but all channels.
“When we give large amounts of these anesthetics for certain nerve blocks around the time of surgery, we have to be very cautious because there is a chance that they could block sodium channels in the heart or the central nervous system,” Rzasa Lynn said. That could be dangerous for the patient.
“We don’t have to fear that consequence, as far as we know, with (Journavx) because it doesn’t affect those other forms of the sodium channel,” she added. “It only targets 1.8.”
Is Journavx non-addictive?
Phase 3 clinical trials of the drug showed no signs of addiction risk. “I can’t say with 100% certainty that it is not addictive,” Rzasa Lynn said. “But there is really no signal for that right now and from its mechanism of action, I would be very surprised if that ends up being the case.”
Are there other potential benefits Journavx offers?
Yes, but they will have to be proven as more people use the drug. Rzasa Lynn said a strength of Journavx lies in its targeting of a single sodium channel, as described above.
“Most of the medications that we use today to relieve pain rely on pretty complex systems,” she said. “The opioid system exists within the brain and spinal cord. And when we target that system, there are a whole bunch of downstream, cascading effects.” Among the most serious are slowed breathing, which can occur because opioids depress the respiratory system, and triggering of the reward system in the brain, which can fuel addiction.
The cascade of problems also applies to NSAIDs, which treat inflammation, Rzasa Lynn said. “They don’t just treat pain. They have a host of systems that they interact with and have effects.” For example, NSAIDs can cause harm to kidneys, especially in older people. Also, NSAIDs can increase the risk of bleeding in patients after surgery, she said.
“The thing we also worry about with NSAIDs in certain populations is risk of heart attack and stroke,” Rzasa Lynn said. There is no sign of that risk with Journavx, she noted.
What types of pain and procedures will Journavx be used to treat?
For now, it is approved to treat moderate and severe acute, not chronic, pain, Rzasa Lynn said. It was studied in patients who had abdominoplasty (tummy tuck) surgery and bunionectomies.
“Both procedures cause a pretty good amount of pain,” she said. The trial compared Journavx’s effectiveness to a combination of the opioid hydrocodone and acetaminophen and also to a placebo. Journavx showed “a statistically significant superior reduction in pain” compared to a placebo without the risks of the opioid medication, according to the FDA.
“I don’t want to overstate its significance because it is not going to completely relieve pain in a way that other drugs can’t, but it is a new tool in our toolbox,” Rzasa Lynn said. She added that Journavx offers an alternative for people who cannot tolerate opioids or NSAIDs. For patients recovering after surgery, it might be also “layered” with opioids to help them achieve better pain control while reducing the amount of opioids they take, she noted.
Finally, Journavx could be a treatment alternative for patients with severe acute pain – say an injured person who visits an emergency room. “A lot of patients may end up going home with Journavx alone who in the past would have been given an opioid prescription,” Rzasa Lynn said.
How is Journavx administered?
It’s an oral pill. Patients take two the first time, then one every 12 hours.
Does Journavx have side effects?
Yes. Side effects in the clinical trials were relatively “benign,” Rzasa said, including skin rashes and itching, muscle spasms and changes in levels of an enzyme called creatine phosphokinase, which helps the body generate energy. She added that itching, one of the most common side effects of Journavx, was less frequent than in patients who took hydrocodone and acetaminophen.
Are there patients who should not take Journavx?
Yes. They include people with severe liver and kidney disease. Those on drugs that affect the enzyme that breaks down Journavx, such as some anti-viral medications, also should not take it.
Journavx has a “potential” interaction with progesterone-based oral contraceptives, so the company recommends that patients switch to an alternative birth control method for 28 days after taking it, Rzasa Lynn said.
The drug has also not been tested on people who are pregnant. Rzasa Lynn said some data from animals suggests risk of harm, “so it probably should not be given to pregnant patients.”
Can Journavx be taken with other medications?
Yes, but patients should talk to their pharmacist to make sure they understand the potential interactions of other medications they are taking with Journavx, Rzasa Lynn said.
Will people presently taking opioid medications for chronic pain be able to switch from them to Journavx?
No, at least for now, because Journavx has not been approved to treat chronic pain. “For people who are already on opioids for chronic, long-term pain, we are not going to switch them to this medication yet,” Rzasa Lynn said.
How does the cost of Journavx compare with other prescription pain medications?
For now, it is more expensive. In its news release announcing FDA approval of the drug, Vertex placed the cost of a single 50-milligram pill at $15.50. That would be $31 for the initial dose. For perspective, Rzasa Lynn said the hydrocodone and acetaminophen combination is significantly less expensive, although the cost can vary significantly, depending on insurance.
Is it realistic to think that the approval of Journavx will lead to new kinds of non-opioid painkillers?
Yes. In fact, Vertex is now studying a new drug to treat diabetic nerve pain. Another trial tests the effectiveness of suzetrigine in treating lumbosacral radiculopathy, generally called sciatica, which is nerve pain in the leg caused by compression in the lower spine.
The data from those studies are not in yet, said Rzasa Lynn, who offered other cautions. “The difference with those pain conditions is not only the nature of them and the cause of the pain versus trauma or surgery, but also the duration of use.”
Simply put, it’s not clear if suzetrigine can be effective when it is used to treat longer-term pain problems like nerve pain.
“The jury is still out in terms of whether [these drugs] could be a replacement for long-term opioid therapy,” Rzasa Lynn.
Other companies are also at work developing drugs that target the Nav1.8 sodium channel to block pain, she noted. For example, Latigo Biotherapeutics has launched a phase one clinical trial of a drug designed to use that mechanism to treat both acute and chronic pain.
Aside from medications, what can I do to manage my pain?
“With acute pain, it’s important to recognize that pain exists for a reason,” Rzasa Lynn said. “Acute pain is a completely beneficial phenomenon. It tells us to avoid doing something that could potentially injure tissue that has been damaged or is healing. So in some ways [getting better] is a matter of listening to your body.”
Chronic pain is another matter, she said. “We want people to be functional. Moving and being active and engaged is not going to make the pain worse. In many cases, it can actually make it better. The act of exercise as a treatment has been shown to impact mood and depression, which we know is commonly experienced by people with chronic pain.”
Rzasa Lynn noted that there are other treatments for pain, such as injections in a specific area, like a joint. These can be effective for people who don’t want to take medications. But the reasons for pain and the ways that individuals experience it vary, so it is essential to get a clear diagnosis, she said.
“I think it’s very important to have a good conversation with your doctor about what is happening to cause the pain, because that will guide the treatment.”