Elagolix Endometriosis Phase III Trials on Track to Commence in Q2
Neurocrine Biosciences has announced that the FDA has responded to the Special Protocol Assessment filed with the FDA on the design of the Phase III program for elagolix in endometriosis.
Neurocrine Biosciences, Inc. has announced that the FDA has responded to the Special Protocol Assessment (SPA) filed with the FDA on the design of the Phase III program for elagolix in endometriosis.
The FDA comments on the February 2012 SPA filing will be incorporated into the final pivotal trial designs. More importantly, the comments from the FDA are not expected to have an impact on the start of the Phase III clinical program of elagolix for endometriosis which is planned to begin during the second quarter of 2012.
"We are pleased with the FDA's response to the SPA, and are looking forward to the start of the Phase III program next quarter," said Kevin C. Gorman, President and Chief Executive Officer of Neurocrine Biosciences.
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