1. VNDA received FDA approval for NEREUS™, treating motion sickness. 2. NEREUS™ is the first new therapy for motion sickness in over 40 years. 3. Efficacy shown in studies with vomiting reduction greater than 50%. 4. Vanda plans to launch NEREUS™ in the coming months. 5. Tradipitant is also being explored for other medical indications.
FAQ
Why Bullish?
The strong FDA approval and novel treatment opportunity can enhance VNDA's market performance, similar to past biotech successes post-approval, boosting investor confidence.
How important is it?
The significant medical advancement and commercial potential of NEREUS™ will likely impact VNDA positively, given the unmet need in motion sickness treatment.
Why Short Term?
The imminent launch of NEREUS™ could drive short-term revenue and visibility, like previous product launches in biotech sectors that saw stock price increases shortly after FDA approvals.
Related Companies
Vanda Pharmaceuticals Secures FDA Approval for NEREUS™ (tradipitant)
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced today that the U.S. Food and Drug Administration (FDA) has granted approval for NEREUS™ (tradipitant), a pioneering oral neurokinin-1 (NK-1) receptor antagonist designed to prevent vomiting induced by motion. This landmark approval marks the first advance in pharmacologic treatments for motion sickness in over four decades, indicating a crucial step in managing this common yet debilitating condition.
Significance of NEREUS™ Approval
According to Mihael H. Polymeropoulos, M.D., President and CEO of Vanda Pharmaceuticals, "This approval underscores the strong scientific evidence in the antiemetic effects of NEREUS™ in motion sickness. For the first time in over 40 years, patients have access to a novel therapy grounded in modern neuropharmacology, offering effective prevention without the limitations of existing options.”
The approval of NEREUS™ is backed by robust data derived from three pivotal clinical trials. These trials, including two Phase 3 studies conducted on boats (Motion Syros and Motion Serifos), featured participants with documented histories of motion sickness:
- In Motion Syros (n=365), the vomiting incidence with NEREUS™ was between 18.3% and 19.5%, compared to 44.3% with placebo (p<0.0001).
- In Motion Serifos (n=316), vomiting rates were 10.4% to 18.3% with NEREUS™ versus 37.7% for placebo (p≤0.0014), representing risk reductions exceeding 50% to 70%.
Historical Context of Motion Sickness
Motion sickness has long been recognized as a critical factor affecting military operations, notably during World War II. The effectiveness of troops was severely impaired due to seasickness during the D-Day invasion in 1944, emphasizing the need for effective antiemetic therapies.
Today, motion sickness impacts civilian life significantly, with estimates suggesting that approximately 25–30% of adults in the U.S., translating to around 65–78 million people, experience symptoms while traveling in vehicles, planes, or boats. Globally, the figure may reach up to one-third of the population. While many cases are mild, an estimated 5–15% of individuals endure severe symptoms that can drastically affect their quality of life.
Mechanism of Action and Future Development
NEREUS™ operates by providing potent and selective antagonism of NK-1 receptors, directly targeting the underlying causes of motion sickness, which stem from sensory conflict that triggers the release of substance P, leading to nausea and vomiting.
The approval of NEREUS™ not only affirms its pharmacological efficacy but also opens pathways for further research into NK-1 antagonism for other vomiting-related conditions. Vanda is also advancing tradipitant in clinical development for:
- Gastroparesis, a condition associated with delayed gastric emptying and persistent nausea/vomiting.
- The prevention of nausea and vomiting induced by GLP-1 receptor agonists, a significant side effect for individuals undergoing treatment for obesity and diabetes.
Upcoming Launch Plans
Vanda Pharmaceuticals is preparing to launch NEREUS™ in the upcoming months, with a commitment to expanding its therapeutic potential across indications influenced by substance P-mediated pathways. This initiative reflects Vanda's broader mission to create innovative solutions for unmet medical needs.