Elagolix was generally safe and well tolerated. The most common adverse events reported more often with elagolix than with placebo were nausea and headache (less than or equal to 12%), consistent with previous clinical studies of elagolix. These events were generally mild or moderate, transient and not associated with study discontinuation. There were no treatment-related Serious Adverse Events.
Hot flash frequency, recorded via an electronic diary after daily prompt, was greatest with leuprorelin (>4 per day during the third month). The mean hot flash frequency during the 3-month treatment period was 0.4 (placebo), 0.9 (elagolix 150 mg), 1.7 (elagolix 250 mg) and 2.6 (leuprorelin).
"These data add to the already excellent safety profile of elagolix gathered from more than 800 subjects who have participated in Phase 1 and 2 studies to date," says Kevin Gorman, Chief Executive Officer at Neurocrine. "Most importantly, we were very pleased to have a productive meeting with the FDA this summer. We now have an alternative assessment of non-menstrual pain in keeping with the Division's recommendations."
Six-Month Tulip PETAL Study Data
Treatment impact on bone mineral density after 6-months treatment will be reported upon study completion.
Daisy PETAL Study (901 Study)
In September 2009, Neurocrine initiated an additional Phase 2 study, the Daisy PETAL Study (901 Study) in the United States. This trial is currently randomizing up to 120 subjects at 37 centers and using a modification to the daily scales for Non-Menstrual Pain and Dysmenorrhea based upon our August 2009 discussions with the Division of Reproductive and Urologic Products at the FDA. Preliminary review of blinded data from the screening period indicates that the Non-Menstrual Pain scale has a wide dynamic range and therefore should be more appropriate for pivotal trials than
|SOURCE Neurocrine Biosciences, Inc.|
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