April 03, 2007
Merck, Lundbeck end development of Phase III insomnia drug
Merck and Lundbeck have scrapped their joint-development program for insomnia treatment gaboxadol.
In a joint-statement, the companies said data from recently completed clinical studies suggests the overall clinical profile for gaboxadol “does not support further development.”
As a result Merck and Lundbeck said they will not file a new drug application (NDA) with the FDA or other regulatory agencies. Ongoing clinical studies are to be terminated.
In October, Lundbeck and Merck extended the target date to submit a NDA for gaboxadol with the FDA to mid-2007 from the first quarter of 2007, because of slower than anticipated enrollment in ongoing Phase III trials.
The companies agreed in 2004 to collaborate on the development and commercialization of gaboxadol in the US
Lundbeck would have received a milestone payment of $75 million from Merck if it moved forward with an application for US registration of gaboxadol.