Sepracor Inc., a research-based pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Lunesta brand eszopiclone, formerly referred to as Estorra, 1 mg, 2 mg and 3 mg tablets for the treatment of insomnia. Insomnia can include difficulty falling asleep as well as difficulty maintaining sleep through the night. The recommended dosing to improve sleep onset and/or maintenance is 2 mg or 3 mg for adult patients (ages 18 to 64) and 2 mg for older adult patients (ages 65 and older). The 1 mg dose is for sleep onset in older adult patients whose primary complaint is difficulty falling asleep.

Data from a landmark, long-term (six-month), double-blind, placebo- controlled safety and efficacy study in 788 patients were reviewed by the FDA as part of the NDA submission for eszopiclone and served as a basis for the FDA's decision to not limit Lunesta's indication to short-term use. Sepracor's six-month study was the first of its kind for a prescription non- benzodiazepine for the treatment of insomnia.

"This novel non-benzodiazepine sleep aid provides a new option for the millions of Americans with chronic insomnia. Unlike all other available prescription sleep aids, which are generally indicated for short-term use, eszopiclone has been studied and approved for use when longer-term treatment is needed," said Andrew Krystal, M.D., director of the Sleep Disorder Research Laboratory and Insomnia Program at Duke University Medical Center, Durham, NC. "The six-month, double-blind, placebo-controlled study of eszopiclone provides unprecedented evidence of sustained efficacy. There were statistically significant improvements in patient-reported measures of sleep onset and sleep maintenance versus placebo for the entire duration of the study with no evidence of tolerance."

Lunesta is indicated for the treatment of patients who experience difficulty falling asleep as well as for the treatment of patients who are unable to sleep through the night (sleep maintenance difficulty).

"The approval of Lunesta makes an important treatment option available for patients who have trouble sleeping. Insomnia can include difficulty falling asleep and/or staying asleep. Lunesta is an important advance for doctors and patients alike, as it can provide sleep efficacy, even over the long term," said Thomas Roth, Ph.D., director of the Sleep Disorders and Research Center at Henry Ford Hospital, Detroit.

"We are very excited about the commercial launch of Lunesta, which will take place in early January 2005. Sepracor's sales force, which includes approximately 1,250 sales professionals, is trained and ready to promote Lunesta to primary care doctors, CNS specialists including psychiatrists, and hospitals in the U.S.," said W James O'Shea, president and chief operating officer at Sepracor. "We believe that Lunesta, with its differentiated product label, will provide physicians with a unique treatment option for their insomnia patients, particularly those with sleep maintenance difficulties and those who suffer chronically."

Sepracor continues to study Lunesta in patients suffering from insomnia. The company also continues to evaluate Lunesta for the treatment of insomnia in patients suffering from depression or pain, and in women who are experiencing the effects of perimenopause.

"The approval of Lunesta is an important milestone for Sepracor," said Mark H.N. Corrigan, M.D., executive vice president of Research and Development at Sepracor. "The dedication and hard work that led to this tremendous achievement continues, as we are conducting a comprehensive Phase IIIB/IV program for Lunesta. We will soon complete initial IIIB/IV studies, which include more than 2,000 patients. Treatment of insomnia, as it occurs concomitantly with other conditions, is a significant area of scientific interest, and Sepracor remains committed to the further research of Lunesta for the treatment of patients with these co-existing conditions."

The Lunesta NDA contained a total of 24 clinical trials, which included more than 2,700 adult and older adult (ages 65 and older) subjects, and more than 60 preclinical studies. Sepracor conducted six randomized, placebo- controlled Phase III studies for the treatment of chronic or transient insomnia in both adult and older adult patients and included these studies as part of the NDA package, which served as the basis for the FDA's approval of Lunesta.