Vertex Pharmaceuticals received approval from the Food and Drug Administration on Thursday for a novel nonopioid pain reliever.
The medication Journavx, also known as suzetrigine, was authorized to treat adults’ moderate to severe acute, or transient, pain. Although some told NBC News they would like to see further research, experts say the drug, which is marketed as nonaddictive, might lower the number of opioids patients are prescribed after surgery or be used by patients who cannot take other pain meds.
The FDA’s Center for Drug Evaluation and Research acting director, Dr. Jacqueline Corrigan-Curay, described the approval as a significant public health milestone in the treatment of acute pain in a statement.
Michael Schatman, a clinical lecturer at NYU Grossman School of Medicine’s department of anesthesiology, perioperative care, and pain medicine, stated, “I believe this drug has great promise in acute pain.” We need more pain management techniques in our toolbox, and this could spare opioids.
Many people still leave the hospital with prescriptions, even though the number of patients returning home from surgery with opioids has decreased recently.When acetaminophen (Tylenol) and nonsteroidal anti-inflammatory medications, like ibuprofen, are insufficient, doctors and patients have limited options because opioids, despite the hazards, are so effective at relieving pain.
Dr. Richard Rosenquist, enterprise chairman in the department of pain management at the Neurological Institute at the Cleveland Clinic, stated that we know from CDC data that anyone who is exposed to opioids has the potential to become dependent on them.
The body uses nerve endings all across the body to sense pain. For instance, when you touch a hot stove, the nerve will alert the spinal cord and later the brain that your hand hurts.
Opioids suppress pain signals by activating opioid receptors in the brain. The neurotransmitter dopamine also floods the brain throughout the process, causing euphoria and triggering the reward system. Opioids can therefore be highly addictive.
By preventing the pain signal from ever reaching the brain in the first place, Vertex’s medication functions quite differently. Sodium molecules rush into the nerve terminal to initiate the signal, which then travels to the brain.
Similar to lidocaine, suzetrigine is a sodium channel blocker. During dental procedures, lidocaine, a local anesthetic, blocks all sodium channels in the area it is applied to, such as the gums. Because sodium channels are present throughout the body and are essential for heart and brain function, a sodium channel blocker given as a tablet, like suzetrigine, needs to be much more specific. Suzetrigine prevents only one sodium channel’s nerve impulses—NaV1.8—from getting to the brain and being perceived as pain.
According to Rosenquist, who was not engaged in the drug’s study, this is the first time we have had something that targets a specific sodium channel.
He added that the procedure doesn’t cause any euphoric feelings or activate opioid receptors.
According to Rosenquist, the research now available indicates that there is absolutely no risk for addiction. It has the same potential for addiction as ibuprofen or Tylenol.
Tummy tucks and bunion surgery
Researchers examined the drug’s post-operative efficacy in phase 3 clinical studies conducted by the pharmaceutical company. For 48 hours following the procedures, patients who had either bunion or stomach tuck surgery were administered either a placebo, an opioid, hydrocodone, and Tylenol every six hours, or suzetrigine every 12 hours.
In the event that they continued to have discomfort following their suzetrigine dosages, some of the patients who received suzetrigine additionally took ibuprofen as a “rescue medication.”
According to Dr. David Rind, chief medical officer of the Institute for Clinical and Economic Review (ICER), a nonprofit organization that assesses the cost, safety, and effectiveness of medications, the results we currently have do not provide much insight on the amount of a rescue medication that was utilized. We don’t know if taking an NSAID right away would have resulted in a greater reduction in pain.
After 48 hours, individuals who received suzetrigine for both bunion surgery and stomach tuck reported pain reductions of almost 50%, which was comparable to the pain reductions experienced by patients who received the opioid in addition to Tylenol.
About 50% of patients in the group that had a stomach tuck and 30% of those who had a bunion surgery reported experiencing some sort of adverse effect, most frequently headache, constipation, or nausea. However, patients who received suzetrigine experienced fewer side effects than those who received an opioid, with the exception of constipation.
It’s difficult to determine exactly what to make of the data because the hydrocodone dosage was also lower than what is usually administered following surgery, Rind added.
Patients receiving suzetrigine for either acute pain or surgery evaluated the medication’s effectiveness in a different phase 3 research. For 14 days or until their pain was away, participants took it every 12 hours. Suzetrigine was rated as good, very good, or excellent at treating pain by 82% of surgical patients and 91% of nonsurgical patients in that study. The majority of side events, which included headache, constipation, nausea, falls, or rashes, were modest, although over 37% did encounter some sort of complication.
Suzetrigine’s phase 3 trials were conducted in patients who had either bunion or stomach tuck surgery, under the direction of Dr. Todd Bertoch, chief medical officer for pain research at CenExel JBR Clinical Research in Salt Lake City.
According to Bertoch, suzetrigine is intended to be used as part of a step-up approach, following Tylenol and NSAIDs, even though the clinical trial indicated that the medication could be useful as a stand-alone treatment for pain, but that it was more successful when patients paired it with ibuprofen.
After that, I’m kind of stuck if I’m still in agony. “An opioid is my next step,” he stated. Suzetrigine accomplishes the purpose of preventing the following step from being an opioid.
He stated that those with kidney or liver illness, for example, for whom Tylenol or NSAIDs are unsafe, could also use suzetrigine.
Questions remain, but doctors see promise
A group of experts assessed the available data on suzetrigine as promising but inconclusive in an ICER assessment last month. According to the group’s definition, this indicates that there is a slight but not zero danger of adverse health effects and that there is a reasonably certain that the medication would help patients in some way.
According to Rind, the type of substance determines the acceptable level of risk of harm. It’s commonly acknowledged, for instance, that cancer medications have severe side effects, but not enough to offset the possible advantages of curing a condition that frequently results in death.
According to Rind, you are prepared to take on a greater risk under those circumstances. For a new pain reliever to be safe, it must be extremely safe, and we won’t know that until it is widely available and in use.
According to him, those who are unable to take traditional painkillers should be the first to try new treatments like suzetrigine. For instance, suzetrigine might be a suitable option for someone with a history of both addiction, which would discourage a doctor from prescribing opioids, and gastrointestinal bleeding, which makes taking NSAIDs risky.
That kind of person is common. Rind remarked, “It’s not like that is a tiny segment of the population.”
Although there are still concerns regarding the medication’s effectiveness and long-term safety, Rind stated that the doctors he has consulted are enthusiastic about it.
In an area where there hasn’t been a new class of medications for a very long time, we have heard from almost all of the pain specialists we spoke with how thrilled they are to have a new class of pain medications, he added.
Suzetrigine appears to be safe and effective for short-term usage, according to Schatman of NYU Grossman School of Medicine. However, he expressed worry that Vertex lacks longer-term safety data. (Schatman is working on a comparable medication for chronic pain and is the senior medical adviser for the German biotech business Apurano Pharma.)
“The FDA requires that there be relatively strong safety data for short-term use,” he added, “but there is no set definition for how long acute pain lasts.” Although doctors frequently prescribe acute painkillers off-label for chronic pain, Vertex is not seeking FDA approval for suzetrigine to treat chronic pain. A phase 2 clinical trial examining suzetrigine for sciatica found that it did not reduce pain any more effectively than a placebo after 12 weeks. “That’s concerning,” he remarked.
“What worries me the most is that we have medications that are showing promise in treating acute pain, but they suddenly extrapolate the results to chronic pain,” he said.
According to Dr. Holly Geyer, a hospital internal medicine practitioner at the Mayo Clinic in Rochester, Minnesota, suzetrigine is unlikely to be effective for chronic pain, which is typically based in the central nervous system, because it inhibits pain signals in the peripheral nervous system, which are the nerves that transmit signals to the central nervous system.
According to Rosenquist, suzetrigine is likely to have a role in pain management even if additional research indicates that it is not as effective as opioids at blocking acute pain.
“You have this tool that you can give to people in situations where they are in the process of getting well, and we are asking them to do things like walking or rehab, and they would have gone home with an opioid,” he added. An appropriate method for handling this is the step-up technique. It might contribute to a decrease in the total amount of opioid exposure.
According to Schatman and Rosenquist, the cost of the medication will probably determine whether doctors choose to use it. Rind, of ICER, said it is likely to depend on both how Vertex prices the new drug and in what contexts, if any, private insurers cover it.
The bottom line is NSAIDs, generic opioids and acetaminophen are cheap, Schatman said, adding that he hopes suzetrigine is priced in a way that allows patients to access it.