Sept 19 (Askume) – Vanda Pharmaceuticals (VNDA.O) said on Thursday the U.S. Food and Drug Administration has declined to approve its drug to treat a digestive disorder and called for more research.
The company’s shares fell nearly 14% to $4.26 in premarket trading.
Vanda is seeking approval from health regulators for a drug called tradipitant to treat symptoms of gastroparesis, a condition characterized by delayed emptying of stomach acid.
The disease causes symptoms such as severe nausea, vomiting, and difficulty eating normal foods.
The decision is another setback for Vanda, coming after the FDA earlier this year declined to extend approval of Hetlioz, a drug used to treat insomnia .
In response to the FDA’s rejection, the company said the design of the additional study requested by the FDA was “inconsistent with the recommendations of leading experts in the field” and said it would continue to work toward approval of the drug.
Vanda said it has repeatedly asked the FDA to convene an expert panel to review the drug, but the regulator has declined to do so.
Tradipitant, a drug licensed from Eli Lilly & Co LLY.N , failed to meet its primary goal of changing the severity of nausea compared with placebo in a late-stage trial over 12 weeks.
Jefferies analyst Andrew Tsai said Vanda still needs to complete additional animal studies and long-term safety data required by the FDA, raising questions about whether the drug can be used long-term.
The FDA placed tradpitant on a partial clinical hold due to safety concerns, halting more than 12 weeks of testing.
The company is also working on a drug to prevent motion sickness vomiting and plans to submit a separate application later this year.
