Merck, Lundbeck End Development of Insomnia Drug

Merck and Lundbeck announced they have discontinued their joint development program for gaboxadol, an investigational drug for the treatment of insomnia. Data from recently completed Phase III 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 with the FDA or other regulatory agencies and are terminating ongoing clinical studies.

"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," Anders Gersel Pedersen, senior vice president and head of development at Lundbeck, said.

"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," Peter Kim, president of Merck Research Laboratories, said.