FDA greenlights first non-opioid treatment for severe pain in 20 years
The U.S. Food and Drug Administration (FDA) has approved the first non-opioid treatment for severe acute pain in over 20 years, introducing a new class of drugs to the market.
On Thursday, Vertex Pharmaceuticals announced the approval of Journavax—the brand name for suzetrigine—which can now be prescribed for all types of moderate to severe acute pain. The drug, a non-opioid pain signal inhibitor, was shown to be effective and well-tolerated, with no signs of addictive potential, according to the company.
Journavax works by blocking a specific protein located near the brain and spine that triggers pain signals. After years of clinical trials and collaboration with the FDA, the drug was shown to be remarkably safe and effective, offering clinicians an alternative to highly addictive opioids, which attach to specific receptors in the brain and spinal cord, reducing the intensity of pain signals sent to the brain.
Unfortunately, opioids come with the heavy cost of potential long-term addiction, which Vertex and the FDA said was not found in clinical trials for Journavax. Roughly 40 million Americans are prescribed an opioid each year, and roughly 85,000 of them develop opioid use disorder as a result.
For clinicians, the ability to prescribe something as effective as opioids without the associated downsides is a game changer.
“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,” Jessica Oswald, MD, an associate physician of emergency medicine and an advisor to Vertex, said in a statement. “I believe Journavax 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.”
For now, the drug is approved only for use by adults, who will take it orally as prescribed. It is also limited to patients suffering from acute pain, such as that caused by an injury or surgery. To date, clinical trials on the use of Journavax as a treatment for long-term, chronic pain have yielded mixed results in terms of efficacy.
The price of the drug is also significantly higher than most other pain medications, including opioids and inexpensive anti-inflammatories, like ibuprofen. Journavax costs about $15.50 per dose, or $31 per day. In some cases, that's more than the price of a month's supply of generic painkillers, including opioids.
Vertex said it has established patient support programs to improve access for patients who would benefit from Journavax. Providers may begin writing prescriptions immediately.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.