FDA Deny Approval of insomnia Drug for Second Time

Boston (DbTechNo) – The FDA have declined to approve an experimental drug to treat people with insomnia.

Somaxon Pharmaceuticals Inc is the manufacturer of Silenor, which has now been disapproved on two separate occasions this year.

The FDA declined to approve the drug back in February, siting concerns relating to heart health were the drug was concerned.

The company have contacted the FDA to request a meeting at which time they would like to discuss the FDA’s stance on the drug.

“We are consulting with our clinical and regulatory advisers and intend to take all steps we deem appropriate to seek approval and commercialization of this product,” said Chief Executive Officer Richard W. Pascoe.

Shares in the company dropped upon news of the FDA decision by more than 60% to $1.22.

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