Research-based pharmaceutical company, Sepracor Inc., announced that it has received notification from the US Food and Drug Administration (FDA) that the agency now anticipates completing its review of the Estorra brand eszopiclone New Drug Application (NDA) on or before February 29, 2004, which is a three-month extension of the original Prescription Drug User Fee Act (PDUFA) date of November 30, 2003. It is Sepracor's understanding that this extension is not related to any specific questions concerning safety or efficacy.

Sepracor does not expect that the three-month extension will have a material impact on the anticipated launch timing of mid-2004.

In September, the FDA requested that Sepracor provide an alternate electronic database format for non-clinical data that had previously been submitted at the end of August 2003. Sepracor has now been advised that the September submission of this alternate format constitutes an amendment to the NDA and has resulted in the three-month review extension. The request from the FDA is intended to facilitate review of this data. Such extensions may generally lead to a more complete first-cycle review, under FDA's good review management principles for NDAs, a guidance document issued during July 2003.

The Estorra NDA, which was submitted to the FDA on January 31, 2003, contained a total of 24 clinical trials, which included more than 2,700 adult and elderly subjects, and more than 60 preclinical studies. A total of six randomized, placebo-controlled Phase III studies, including one with a positive control, for the treatment of chronic or transient insomnia were conducted in both adult and elderly patients and were part of the NDA package.

According to the National Institutes of Health web site, insomnia affects more than 70 million Americans. Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking up too early, an inability to fall back to sleep, or awakening feeling unrefreshed.

According to the National Sleep Foundation (NSF) Sleep in America Poll 2003, 37 million older Americans suffer from frequent sleep problems that, if ignored, can complicate the treatment of several other medical conditions, from arthritis to diabetes, heart and lung disease and depression. This NSF poll shows that poor sleep among older adults often goes unnoticed by the medical community. Although the majority of older adults (67 per cent) report frequent sleep problems, only about seven million elderly patients have been diagnosed.

The US market for prescription sleep products, not including off-label (not indicated for the treatment of insomnia) use of central nervous system agents for the treatment of insomnia, was approximately $1.5 billion in 2002. The US prescription sleep agent market grew at a rate of almost 25 per cent for the past two years, according to IMS Health information.