The FDA wants more data about indiplon, which has been stalled for more than a year, and the news sent shares in Neurocrine Biosciences down nearly 45 percent this morning. The request comes six months after the company resubmitted its application for 5mg and 10mg doses. The FDA denied approval in May 2006 over issues with a 15mg dose, which was supposed to become a big seller.
The earlier setbacks prompted Pfizer to scuttle its collaboration, which in turn forced Neurocrine to shrink its staff. But the company pushed ahead, meeting with agency officials last August to review their requirements. Now, the FDA wants additional clinical trial and preclinical study data. The requirements include an objective/subjective clinical trial in the elderly, a safety study, and preclinical study data evaluating indiplon during the third trimester of pregnancy, the company said.
"While we are disappointed in the FDA action, we will accept the FDA's offer to discuss the applications via a meeting or telephone conference in order to clarify and determine the next steps required," Neurocrine's ceo, Gary Lyons, says in a statement.
2 Comments
The FDA just can't restrain itself from "moving the goalposts," can it?!
If it's not careful, it will succeed in offshoring the entire US drug development industry!
I don't know, and I work for pharma. The FDA asks for a lot, but at least the US market reimburses drugs well. When Canada's FDA moves the goalposts, then we can complain.