WASHINGTON , Sept. 19, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA ) today provided an update on its tradipitant development program.
On September 18, 2024 , the U.S. Food and Drug Administration (FDA) declined to approve Vanda's New Drug Application (NDA) of tradipitant for the treatment of symptoms in gastroparesis, providing Vanda with a Complete Response Letter (CRL).
Gastroparesis is a serious condition that is characterized by delayed gastric emptying and associated with severe nausea, vomiting, difficulty finishing a normal meal and other symptoms that have a significant impact in people's everyday living and functioning. Gastroparesis is often associated with diabetes but is also found in nondiabetic individuals and has recently been associated with the class of GLP1 inhibitors. There has been no effective treatment approved by the FDA in over 40 years.
Vanda's tradipitant application included evidence from two placebo-controlled studies, the results of which were published in peer review journals. 1,2 The evidence of efficacy was further supported by exposure response data from a large open label study as well as the real world experience of dozens of patients treated in an expanded access program, some for several years. The CRL was conclusory in nature, generally disregarded the evidence provided and instead suggested that Vanda conduct additional studies with a design and duration inconsistent with the advice of key experts in the field a.