Groundbreaking Drug Launches
Suzetrigine (JOURNAVX)
Mechanism of Action: Nav1.8 voltage-gated sodium channel inhibitors Drug class: Small molecules Originator and Owner: Vertex Pharmaceuticals Indication: Acute pain
Approval Date: 30 January, 2025 Trials: VX22-548-104 and VX22-548-105
Acute pain
Acute pain is sudden or intense pain that typically arises from surgery, injury, trauma, or medical treatments. Doctors define it as pain associated with a specific cause that can be treated and alleviated. Acute pain generally diminishes or resolves as the body heals.
Additionally acute pain is a major concern in emergency departments as trauma patients often experience acute pain, with high prevalence rates at both admission and discharge.
Why is Suzetrigine poised to make an impact in 2025?
Acute pain treatment medications face several challenges, including side effects, patient-related factors, and practitioner-related factors.
Side Effects: Opioids can cause side effects such as nausea, vomiting, respiratory depression, and sleep apnea. These effects can be more pronounced in older adults. Patient Factors: Some patients may be hesitant to use analgesics due to concerns about side effects or the potential for addiction. Opioid Dependence: Patients with opioid dependence may experience issues like opioid-induced hyperalgesia, opioid tolerance, or withdrawal symptoms.
Suzetrigine poised to make an impact in 2025:
The FDA has approved JOURNAVX™ (suzetrigine), a non-opioid, oral pain signal inhibitor for adults with moderate-to-severe acute pain. This effective, well-tolerated medication is free from addictive potential and can treat all forms of moderate-to-severe acute pain. Its approval marks a historic milestone, providing a new non-opioid option for the 80 million Americans prescribed for acute pain annually. JOURNAVX is the first new class of pain medication approved in over 20 years, priced at $15.50 per 50mg pill. By 2030, sales of suzetrigine are projected to reach $2.9 billion.
“Sales of JOURNAVX are projected to reach $2.9 billion by 2030.”
Regulatory milestones for suzetrigine
Registrational Trials
The US FDA granted approval for suzetrigine based on positive data from the two pivotal phase IIII trials, VX22-548-104 (bunionectomy) and VX22-548-105 (abdominoplasty).
VX22-548-104:
A phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of suzetrigine for acute pain after a bunionectomy (NCT05553366).
VX22-548-105:
A phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of suzetrigine for acute pain after an abdominoplasty (NCT05558410).
"Treatment with VX-548 led to statistically significant improvement in pain compared to placebo as well as a clinically meaningful reduction in pain from baseline in both the abdominoplasty and bunionectomy randomized controlled trials"