Vanda’s tradipitant falls short for gastroparesis as FDA requests ‘additional studies’
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The FDA has issued a complete response letter to Vanda Pharmaceuticals indicating it cannot approve the company’s new drug application seeking approval for tradipitant as a treatment for gastroparesis.
According to a company press release, the FDA suggested that Vanda “conduct additional studies” for its neurokinin-1 receptor antagonist, tradipitant, a leading drug contender for gastroparesis.
The company fired back that the FDA has “generally disregarded the evidence provided,” and the design/duration suggestions for further studies were “inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding and natural course of the disorder.”
The Vanda application was based on data from a phase 3 multicenter, double-blind, placebo-controlled, randomized clinical trial, which assessed the safety and efficacy of tradipitant among 201 adult patients with idiopathic (51.2%) or diabetic (48.8%) gastroparesis.
The primary studied endpoint was change from baseline to week 12 in average daily nausea score, while secondary outcomes included change from baseline in other symptoms of gastroparesis, nausea-free days and patient-reported outcome questionnaires.
Although patients with high blood levels of tradipitant reported significant improvement in gastroparesis symptoms — including vomiting, bloating and pain — these changes did not reach statistical significance. Moreover, the drug failed to meet statistically significant change in nausea severity at 12 weeks vs. placebo.
In a company release, Vanda accused the agency of delaying its decision by more than 185 days and failing to provide the company with an opportunity for a hearing in lieu of an approval.
Despite this regulatory setback, Vanda maintains that tradipitant has “substantial evidence of efficacy” with a “favorable benefit risk profile” for patients with gastroparesis. The company plans to pursue the marketing authorization for tradipitant and support the expanded access program that is currently serving select patients with gastroparesis.
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