Friday, March 6, 2009

Sepracor anxiety drug fails in Phase 2 study

By Marc Songini

Marlborough-based pharmaceutical company Sepracor Inc. has found that its preliminary Phase 2 study for an anxiety disorder treatment has failed.

This week, Sepracor (Nasdaq: SEPR) announced that it completed the analysis and validation of preliminary results for the drug SEP-225441. The drug is a modified-release formulation of eszopiclone, meant to treat generalized anxiety disorder. The efficacy and safety study included 440 patients, and the researchers used the Hamilton Anxiety Rating Scale for their evaulation. This is a standard scale for evaluating anxiety in clinical trials and consists of a list of symptoms associated with the condition.

However, Sepracor explained that the study in fact didn’t meet its primary efficacy endpoint, which was the reduction of general anxiety symptoms. Although the company said it was disappointed with the preliminary analysis of the study results, it’s now further analyzing the data to determine if any of the secondary endpoints were met. It’s also wondering “whether this compound warrants further clinical development,” stated Mark Corrigan, executive vice president of research and development at Sepracor.

Sepracor is a research-based pharmaceutical company seeking to treat and prevent human disease by developing products that are directed toward large and growing markets and unmet medical needs. Its portfolio of pharmaceutical products and candidates cover respiratory and central nervous system disorders. Current products on the market include the Lunesta sleep drug. Last month, Sepracor reported there were two filings from other companies to create generic versions of Lunesta.