Logo

Myovant and Pfizer Report Result of Relugolix Combination Therapy in P-III (SPIRIT 1 & 2) Studies for Endometriosis-Associated Pain

Share this

Myovant and Pfizer Report Result of Relugolix Combination Therapy in P-III (SPIRIT 1 & 2) Studies for Endometriosis-Associated Pain

Shots:

  • The P-III (SPIRIT 1 & 2) studies evaluates relugolix 40mg + estradiol 1.0mg and norethindrone acetate 0.5mg vs PBO in ~1,200 women with pain associated with endometriosis. The combination therapy is available as Myfembree in the US
  • The studies achieved co-primary EPs i.e., 75% of women achieved reductions in dysmenorrhea over 27% & 30% in PBO @24wks.; 59% & 66% vs 40% & 43% in non-menstrual pelvic pain. In the 2EPs, reductions in dyspareunia & opioid use; opioid free (86% & 82% vs 76% & 66%) @24wk., was well-tolerated including bone mineral density loss of <1% @24wks.
  • The results were published in The Lancet. Both study results & OLE study were incorporated into a Myfembree' sNDA with an anticipated PDUFA date of Aug 2022

Ref: Pfizer | Image: Pfizer

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions