Sepracor submits NDA for Estorra brand eszopiclone for treatment of insomnia
MARLBOROUGH, MASS., Feb. 3, 2003 -- Sepracor Inc. announced that it has submitted a New Drug Application (NDA) to the FDA seeking clearance to market Estorra brand eszopiclone 2 mg and 3 mg tablets for the treatment of transient and chronic insomnia.
Estorra was studied in the 3 mg dosage strength for adults and in the 2 mg dosage strength for treatment of the elderly population.
The NDA contains 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, were conducted for the treatment of insomnia in both adult and elderly patients.
Of particular significance is Sepracor's completion of what it believes to be the first successful double-blind, placebo-controlled, 6-month chronic efficacy and safety trial, which included 788 subjects for the treatment of chronic insomnia. This was followed by a 6-month open-label extension to study safety for up to 12 months.
"Sleep initiation and sleep maintenance are important medical needs that we hope to address with Estorra," said Timothy J. Barberich, Chairman and Chief Executive Officer at Sepracor. "Disturbed sleep maintenance, in particular, is a primary complaint seen in both transient and chronic insomnia patients and is especially pervasive in the elderly. In eight clinical trials, we were able to explore the positive relationship between sleep maintenance and next-day improvements, such as alertness and ability to function, in both the adult and elderly populations.
"We hope that Estorra will provide doctors and patients with a new and meaningfully differentiated treatment option."
According to the National Sleep Foundation, insomnia affects approximately 50 million people in the U.S. Insomnia symptoms may include difficulty falling asleep, awakening frequently during the night, awakening too early in the morning, or awakening feeling unrefreshed. Causes of insomnia can include depression, anxiety, pain and other medical conditions, as well as environmental factors such as jet lag or shift work.
Under the Prescription Drug User Fee Act, the FDA has 60 days to review an NDA submission prior to officially accepting it for filing.
Source: Sepracor Inc. www.sepracor.com
Posted: February 2003