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Another Elagolix Study Supports AbbVie's NDA, But Which Dose?

 
• By Mandy Jackson

A second positive Phase III clinical trial for AbbVie Inc.'s elagolix in the treatment of endometriosis pain in premenopausal women supports a new drug application (NDA) submission to the US FDA in 2017, but it's unknown whether both doses tested in the trials will be viable in the real world.

A second positive Phase III clinical trial for AbbVie Inc.'s elagolix in the treatment of endometriosis pain in premenopausal women supports a new drug application (NDA) submission to the US FDA in 2017, but it's unknown whether both doses tested in the trials will be viable in the real world.

AbbVie said on Feb. 10 that both doses of its gonadotropin-releasing hormone (GnRH) inhibitor (150mg once daily and 200mg twice-daily) showed statistically significant reductions in menstrual pain (dysmenorrhea) and non-menstrual pelvic pain (NMPP), the Phase III trial's co-primary endpoints

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