The application was supposed to be filed in the first quarter of 2007. The companies now plan to submit the new drug application in mid-2007.
The companies said the delay in the submission for gaboxadol resulted from slower than anticipated enrollment in ongoing phase III trials.
Gaboxadol is a novel investigational drug in phase III development for the treatment of insomnia. In 2004, the companies agreed to collaborate on the development and commercialization of gaboxadol in the US.