In a groundbreaking development, the FDA has approved Vertex's suzetrigine for the treatment of moderate to severe acute pain. This approval marks the introduction of a pain medication to the market in decades, offering a new hope to patients with pain.
How suzetrigine works
Suzetrigine operates by inhibiting the voltage-gated sodium channel 1.8 (NaV1.8), which plays a crucial role in pain transmission. Unlike other sodium channel blockers, such as local anesthetics, suzetrigine does not affect sensory and motor functions. This specificity is due to the location of NaV1.8 in neurons responsible for pain transmission ("nociceptors"). The nociceptors are located outside the central nervous system. Therefore, unlike many other currently available pain medication, the action on brain function is minimal, if any. The community has to be grateful to the National Institute of Health (NIH) for funding decades of research in the NaV1.8 channel, paving the way to the development of suzetrigine.
Safety and efficacy
The drug was well tolerated in clinical trials, with few and mostly minor adverse events. In the two studies on postoperative pain that compared suzetrigine with placebo and with hydrocodone (an opioid) plus acetaminophen, the incidenceof nausea was 20% with suzetrigine, 25% with placebo, and 33% with hydrocodone-acetaminophen. Therefore, postoperative nausea was not primarily attributable to suzetrigine. Itch and muscle spasms were more frequent than with placebo, but occurrred in only 2.1% and 1.3% of patients, respectively.
Importantly, suzetrigine did not outperform opioids in pain management. However, by not acting on opioid receptors, there will not be concerns of respiratory depression, dependence, and other known downsides of opioids (read more here).
How will suzetrigine compete with other medications?
The medication must compete with lower-cost options, such as non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and opioids, among others. We expect information on costs and coverage by health care systems to be available soon.
Will suzetrigine be helpful in chronic pain?
Chronic pain conditions represent a significant unmet need due to the poor efficacy of available treatments. Studies supported by Vertex and not yet published seem to show potential efficacy in painful diabetic peripheral neuropathy, but not in lumbar radicular pain. Definitely, more studies are needed.
The development path of suzetrigine teaches a lesson
Unlike most therapeutics developed over the past few decades, the identification of suzetrigine's target (NaV1.8 channel) did not primarily rely on animal studies, but benefitted by research on human models. Reliance of drug development on animal research may be one of the main reasons for the many failures of translation of basic research into therapeutics for human use (read more here).
Conclusions
The approval of suzetrigine represents a significant milestone in pain management, offering a new, safer alternative for patients with moderate to severe acute pain. Use of opioids in the postoperative phase is a risk factors for long-term opioid use. Being an alternative to opioids, suzetrigine may reduce the number of patients who will be on long-term opioids after surgery.
As its potential indications in chronic pain are being explored, suzetrigine could become a very important tool in the fight against pain, providing relief without the risks associated with opioids.
Opioids will still be needed in pain management, but their use will likely be less thanks to the availability of suzetrigine.
The journey of suzetrigine from discovery to approval underscores the importance of innovative approaches in drug development that rely on human neuroscience, paving the way for future breakthroughs in pain management.
Comentários