Sepracor slides on trial failure and Lunesta halt
Sepracor says FDA stopped 2 Lunesta studies, and depression candidate failed in trial
MARLBOROUGH, Mass. (AP) -- Sepracor Inc. reported a pair of research setbacks, as it said a depression drug candidate failed in a clinical trial, and two studies of its insomnia drug Lunesta were stopped by the Food and Drug Administration.
The company also said the FDA placed a hold on two studies of Lunesta, which could hurt the company's efforts to extend its patent on the sleep aid by allowing Sepracor to market Lunesta for use by children. A drug candidate called SEP-22589 did not reach its main goal in an eight-week mid stage trial, Sepracor said, as it did not significantly reduce the symptoms of depression compared with a placebo.
Sepracor announced the results late Wednesday, and in morning trading Thursday, its shares lost $3.26, or 18 percent, to $14.63.
The FDA questioned the relevance of data from the non-clinical Lunesta studies, Sepracor said. The patents supporting Sepracor are currently scheduled to expire in 2012. The company said the trial hold is not related to any results of the study, and does not affect prescriptions of the drug or any trials of Lunesta in adults.
Sepracor started the studies in April.
Sales of Lunesta, or eszopiclone, were flat in 2008. Sepracor's revenue from the drug totaled $600.3 million for the year, down slightly from $600.9 million in 2007. |
