Contributed by William Angelos| 18 December, 2004 19:30 GMT
Insomnia can be a serious condition. If left untreated, it may become progressively worse and affect a person's emotional, mental and physical health.
The U.S. Food and Drug Administration (FDA) has approved Sepracor Inc.'s (Nasdaq: SEPR) Lunesta brand eszopiclone, a prescription non-benzodiazepine, for the long-term treatment of insomnia. 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).An estimated 100 million adult Americans suffer from either chronic or occasional insomnia. 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.
Prescription Non-Benzodiazepine
The Lunesta New Drug Application (NDA) contained a total of 24 clinical trials, which included more than 2,700 adult (18 to 64 years of age) and older adult (65-plus years of age) 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.
Data from a long-term (six-month), double-blind, placebo-controlled safety and efficacy study in 788 patients were reviewed by the FDA as part of Sepracor's 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.
$2.1 Billion Market
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.
Insomnia can be a serious condition. If left untreated, it may become progressively worse and affect a person's emotional, mental and physical health.
The U.S. market for prescription sleep products, not including off-label (not indicated for the treatment of insomnia) use of central nervous system (CNS) agents for the treatment of insomnia, was approximately $2.1 billion between November 2003 and October 2004, representing a 20 percent increase over the same period the previous year, according to IMS. |
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