Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) received a negative FDA verdict on its drug Hetlioz, the company said Monday.
Vanda said Monday ahead of the market open the FDA has issued a complete response letter for its sNDA for Hetlioz in treating jet lag disorder.
Hetlioz is one of the commercial products the company markets for the treatment of non-24-hour sleep-wake disorder — a serious, rare and chronic circadian rhythm disorder.
The company submitted the regulatory filing based on a study which showed that jet lag disorder patients slept nearly three hours longer over the three nights following their transatlantic trip when treated with Hetlioz than they did when they were untreated.
This was consistent with Vanda's jet lag simulation studies, according to the company.
The FDA said the measures demonstrating improved sleep are of unclear clinical significance.
The company said it is perplexed by the conclusion.
The FDA also made additional observations on various aspects of Vanda's sNDA.
Vanda said it intends to consider each observation as it plans for continued engagement with the FDA on this matter.
"We are deeply disappointed to have not received approval at this time, given our previous discussions with the FDA on this program," CEO Mihael Polymeropoulos said in a statement.
On July 22, Vanda revealed an FDA communication regarding deficiencies the agency identified in the Hetlioz sNDA that preclude labeling and post-marketing commitments. The announcement sent the stock down 4.5%.
Why It's Important
Jet lag disorder sufferers use unapproved remedies that not only fail to address the symptoms or the underlying cause of the disorder, but also are risk-fraught due to dangerous side effects.
"Vanda remains committed to obtaining FDA marketing approval for tasimelteon in jet lag disorder in order to address this significant unmet medical need," the company said.
In pre-market trading Monday, Vanda shares pulled back to a support around the $12-$13 area. The stock turned positive in the regular session and was trading 1.71% higher at $15.45 at the time of publication Monday.
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