Chronic pain is the leading cause of disability in America. An estimated 50 million adults in the United States experienced chronic pain (i.e., pain lasting ≥3 months) in 2016, resulting in substantial health care costs and lost productivity. During 2021, an estimated 20.9% of U.S. adults (51.6 million persons) experienced chronic pain, and 6.9% (17.1 million persons) experienced high-impact chronic pain (i.e., chronic pain that results in substantial restriction to daily activities).
Chronic pain (i.e., pain lasting ≥3 months) is a debilitating condition that affects daily work and life activities for many adults in the United States and has been linked with depression, Alzheimer disease and related dementias, higher suicide risk, and substance use and misuse.
Chronic pain has Macroeconomic impact by reducing productivity and increasing medical costs.
The opioid crisis was largely caused by the false claim that opioids such as oxycontin did not have the same addictive potential of other opioids (such as morphine). To reduce the addiction of chronic pain patients doctors were advised to cut off the supply of opioids. This left many patients in agony. Some turned to heroin and died of overdose.
There’s a huge need for drugs to address chronic pain. Some doctors are prescribing Gabapentin (Neurontin) off-label for chronic pain. Gabapentin is approved for seizures and post-herpetic neuralgia; gabapentin enacarbil is approved for restless legs syndrome. Despite limited indications, gabapentin and its cousin, pregabalin (Lyrica), are widely prescribed off-label (https://www.medpagetoday.com/neurology/generalneurology/108370) for various other pain syndromes.
A large new study (n = 52,000) shows that dementia risk was more than double and mild cognitive impairment risk more than triple among those ages 35 to 49 in chronic back pain patients who used gabapentin for a long time. A similar pattern emerged among those 50 to 64 years old.
Gabapentin’s clinical trials were performed for it prescribed uses. This shows the problem of using drugs off-label – there’s no data unless someone decides to research it on their own using medical records. There’s no long-term data even for on-label drugs since FDA approval relies on clinical trials that last a short time.
There’s clearly a need for non-addictive drugs for chronic pain.
Journavx is the first new kind of painkiller in more than 20 years, and the medical community is cautiously optimistic that Journavx (manufactured by Vertex Pharmaceuticals) doesn’t have the same addictive potential as opioids do.
But the new pills are expensive, and not everyone has been able to access them, thanks to a narrowly-focused FDA approval and limited insurance coverage.
On Jan. 30, 2025 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) 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. 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.
Studies are now underway that could help Journavx win additional FDA approvals for some kinds of chronic pain. Vertex says it is specifically studying Journavx in patients with diabetic peripheral neuropathy, painful nerve damage in the limbs, and lumbosacral radiculopathy, a type of low-back pain caused by a pinched nerve.
But approval will take a while. There’s a big difference between taking a pain killer for a couple of weeks for acute pain and taking it potentially for life for chronic pain.
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.
Wow! That’s super expensive! Since this is a brand-new drug there won’t be any generic equivalents. If JOURNAVX is approved for chronic pain it could become a blockbuster for Vertex and a burden on insurers.
Wendy