Sepracor ran into an unexpected setback on a mid-stage therapeutic for depression. Researchers say that the drug--SEP-225289--failed to deliver positive data in a trial that dosed 514 patients over eight weeks.
The developer says that the drug levels that reached patients' bloodstreams were lower than they had seen in earlier studies and that the side effect profile that emerged was different as well. And on top of that, U.S. regulators ordered a halt to two trials of the insomnia drug Lunesta in children. Regulators have concerns about non-clinical data that could be relevant in pediatrics. The double whammy cost Sepracor about 15 percent of its share price.
Sepracor says it's evaluating the mid-stage drug program before deciding how to proceed. SEP-225289 is a triple reuptake inhibitor based on its activities at the serotonin, norepinephrine and dopamine transporters.
"While we are clearly disappointed with the findings from the analysis of the preliminary study results, we are in the process of further analysis of the dose response and secondary endpoints to determine how or if we will take this novel mechanistic approach forward," Mark Corrigan, Sepracor's executive vice president of research and development.
- read the Sepracor release
- read the report from Reuters