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news.Neurocrine Biosciences has completed the submission of its FDA application to market indiplon tablets for the treatment of insomnia in both adult and elderly patients.
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The company began submitting data for the application in April 2005. The filings are based on clinical data supporting that both indiplon capsules and tablets show significant improvement in all sleep onset, sleep maintenance and sleep quality parameters.
The approval request contains data from 72 clinical trials and includes a comprehensive safety and efficacy evaluation in more than 7,500 subjects.
Clinical trial results have shown that indiplon capsules and tablets help patients consistently fall asleep faster, increase the amount of time they sleep during the night, decrease number of nighttime awakenings and improve overall sleep quality over the course of short or long-term treatment.
The drug also avoids problems of intolerance when administered nightly for up to three months or withdrawal upon discontinuation of nightly dosing; complications often seen with extended use of older-generation sleep medications.
“We believe that the flexibility of indiplon in treating the individual sleep needs of patients, coupled with the demonstrated long-term safety, make it an important advancement in the treatment of insomnia,” said Gary Lyons, president and CEO of Neurocrine Biosciences.