Vanda Pharmaceuticals Accepts FDA Opportunity for a Hearing on New Drug Application for Tradipitant in Gastroparesis

Core Viewpoint - Vanda Pharmaceuticals is challenging the FDA's rejection of its New Drug Application (NDA) for tradipitant, a treatment for gastroparesis, citing procedural violations and insufficient consideration of evidence [4][5][6][17]. Company Overview - Vanda Pharmaceuticals Inc. is focused on developing innovative therapies to address unmet medical needs, particularly in the field of gastroparesis, a condition with no new drug approvals in over 40 years [18]. Drug Development and Clinical Trials - Tradipitant, a neurokinin 1 receptor antagonist, has been studied for nearly a decade, with over 1,000 patients treated, including ongoing treatment through an expanded access program [3][4]. - The company conducted two placebo-controlled studies and one open-label study to assess the efficacy and safety of tradipitant [3]. FDA Review Process - The FDA rejected Vanda's NDA in September 2024, claiming that substantial evidence of efficacy was not established [4]. - Vanda argues that the FDA did not adhere to legal requirements, delaying the review process by six months and failing to provide a hearing opportunity as mandated [5][6]. Efficacy Evidence - In Study 1, tradipitant significantly improved nausea severity compared to placebo (p value = 0.0099) [9]. - Study 2 showed no statistically significant difference between tradipitant and placebo (p value = 0.7411) [10]. - Vanda conducted additional analyses suggesting tradipitant's superiority over placebo, which the FDA disputed [11]. Regulatory Standards - Vanda contends that the FDA's interpretation of the "substantial evidence" standard is overly stringent, requiring two well-controlled studies with significant results, which is not consistent with statutory language [15][16]. - The company emphasizes that the substantial evidence standard is relatively low and should allow for the approval of effective drugs, especially for conditions like gastroparesis [14][16]. Next Steps - Vanda has accepted the FDA's offer for a hearing regarding the NDA, which must commence within 120 days [17].