Merck and Lundbeck Put Insomnia Drug to Sleep

The American Drug Manufacturer Merck and its Danish partner Lundbeck decided to stop the development of their anti insomnia drug, which was in final stages of human trials, after the study found safety problems attributed with use of the drug, including hallucinations. The companies said they stopped their experiments with the drug, which includes the chemical Gaboxadol, after three years of developing the drug together. Merck and Lundbeck where planning to file for FDA approval in the summer. The drug was expected to be first in a new line of sleeping drugs.

Anders Gersel Pedersen, head of development at Lundbeck, said that half a dozen trials showed the drug achieved its goals and helped those treated to sleep deeply and wake up refreshed. Later, in more recent trials, problems were discovered. According to Pedersen, one experiment found that the drug had little effect in low doses, while another experiment found that the drug loses efficiency with time. A third experiment with medium levels of Gaboxadol taken by drug abusers, as required by the FDA, because of the concern that sleeping pills tend to cause dependence, exposed side effects included disorientation and hallucinations. The effects were also seen in other patients who had taken the medicine above the prescribed dose.

"We did not want to bring a product to market with such a shallow risk/benefit profile," said Pedersen. "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." When Lundbeck CEO Claus Braestrup was asked whether Gaboxadol may be used by the company to treat other illnesses, Braestrup answered: "We will consider alternatives but it is not likely we will go forward [with the drug]."

                                 

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