Vertex Gains FDA Approval for JOURNAVX™, a Non-Opioid Pain Treatment
Friday, January 31, 2025
Vertex Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved JOURNAVX™ (suzetrigine) for the treatment of moderate-to-severe acute pain in adults.
Acute pain is a common condition that can arise from surgery, injury, or medical procedures, affecting over 80 million people in the US each year. Of these, around 40 million receive opioid prescriptions, and a significant percentage develop prolonged use or dependency.
The introduction of JOURNAVX aims to help address this issue by providing a new treatment option with a favourable safety profile.
JOURNAVX works by blocking NaV1.8, a voltage-gated sodium channel that plays a role in transmitting pain signals through peripheral pain-sensing neurons. By targeting these specific pathways rather than acting on the brain, the medication is designed to relieve pain effectively while avoiding the risks associated with opioid treatments.
The approved dosage regimen involves taking the medication twice daily.
The oral, non-opioid medication is designed to selectively inhibit NaV1.8 pain signals, providing an effective alternative to existing treatments without evidence of addictive potential.
JOURNAVX is the first new class of pain medicine to be approved in over 20 years and offers a non-opioid option for individuals requiring relief from acute pain.
The approval is expected to provide an alternative for millions of patients who are prescribed pain medication annually, reducing reliance on opioids.
Vertex has set the wholesale acquisition cost for JOURNAVX in the US at $15.50 per 50mg pill. The company has also introduced patient support programmes to improve access to the treatment.
In addition to acute pain, Vertex is conducting further research into suzetrigine for peripheral neuropathic pain.
Ongoing clinical trials include a Phase 3 programme for patients with painful diabetic peripheral neuropathy, and the company plans to expand studies into painful lumbosacral radiculopathy following discussions with regulatory authorities.
Source: vrtx.com
