(Reuters) – Vanda Pharmaceuticals Inc said on Thursday the U.S. Food and Drug Administration has refused to approve its drug to treat a stomach condition that interferes with digestion and called for further study.
The company’s shares fell about 14% to $4.26 in premarket trading.
Vanda (NASDAQ:) had been seeking health regulator approval for its drug tradipitant, which treats symptoms of gastroparesis, a condition characterized by delayed gastric emptying.
The disease is accompanied by symptoms such as severe nausea, vomiting, and difficulty finishing normal meals.
The decision is another blow for Vanda after the FDA refused to expand approval of its insomnia treatment Hetrioz earlier this year.
In response to the FDA’s rejection, the company said the design of the additional studies requested by the FDA was “inconsistent with the advice of leading experts in the field,” adding that it would continue to pursue approval of the drug.
Vanda has repeatedly asked the FDA to convene an expert committee to review the drug, but the FDA has refused.
Tradipitant, licensed by Vanda from Eli Lilly (NYSE:), failed to meet its primary goal of changing the severity of nausea compared to placebo over 12 weeks in a late-stage trial.
Jefferies analyst Andrew Tsai said Vanda still must meet the FDA’s requirements for additional animal studies and long-term safety data, raising questions about whether the drug can be prescribed for chronic use.
The FDA had placed tradipitant on a partial clinical trial hold, prohibiting studies beyond 12 weeks due to safety concerns.
The company is also researching a drug to prevent vomiting during motion sickness and plans to file a separate application for it later this year.
