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news.Merck & Co. and Lundbeck have ended their joint development program for gaboxadol, an investigational new medicine for the treatment of insomnia currently in phase III development.
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The companies said that data from recently completed clinical studies suggest that the overall profile for gaboxadol in insomnia does not support further development.
As a result of this new information, Merck and Lundbeck will not file a new drug application for gaboxadol for the treatment of insomnia with the FDA, or other regulatory agencies worldwide, and are terminating ongoing clinical studies.
“The termination of our joint insomnia development program with Lundbeck is clearly disappointing,” said Dr Peter Kim, president of Merck Research Laboratories.
“Although Merck will not be continuing with the clinical development program for gaboxadol for the treatment of insomnia, we remain committed to our neuroscience and sleep disorders research program, one of nine priority disease areas for research and product development.”