Merck & Co., Inc., and H. Lundbeck A/S announced the discontinuation of their joint development programme for gaboxadol, an investigational new medicine for the treatment of insomnia currently in phase III development. Data from recently completed clinical studies suggest that the overall clinical 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 US Food and Drug Administration (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 S Kim, president of Merck Research Laboratories. "Lundbeck has been a valued partner for the past three years, and our collaboration has benefited from the strong relationship between the companies. Although Merck will not be continuing with the clinical development programme 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. As part of that commitment, we also welcome the opportunity to engage in other joint development efforts with Lundbeck in the future."
"When developing new and innovative medicines there are always risks of failure, particularly for broad-based therapeutics which often carry a higher threshold for demonstrating value to physicians, and ultimately to patients," said senior vice president Anders Gersel Pedersen, head of development at Lundbeck. "It is clearly disappointing, but we will continue to develop new and innovative medicines to treat unmet medical needs and to seek strong and productive partnerships like the one we have experienced with Merck to maximize these efforts."