Neurocrine said that it is now preparing a formal meeting request to the FDA to discuss the 2007 approvable letter. The FDA has notified the company that its new drug application for its indiplon insomnia treatment will require additional clinical and preclinical data.
Gary Lyons, president and CEO, said: “It is with great disappointment that we have to make this difficult decision that will have such an effect on so many of our employees and their families. We are greatly saddened to move in this direction after our employees have continually demonstrated only the highest level of dedication and commitment. However, in order to meet our goals on other high-priority programs, we have to refocus our resources as quickly as possible.”
Mr Lyons also said: “We will maintain our focus on determining the path forward with indiplon after interactions with the FDA, and our efforts on GnRH, as we move expeditiously toward partnering this program. We will also continue with focused R&D efforts aimed at treating diseases of the central nervous and endocrine systems. We intend to continue to conservatively manage our cash resources and review collaborative alternatives to fund the advancement of our pipeline.”