Brahim_av schreef op 11 februari 2023 09:34:
Ter info: goed nieuws bij Fuji Pharma die Estelle (E4) gebruikt voor een andere indicatie, dysmenorrhea , een probleem tijdens menstruatie)
Positive top-line results in Phase III studies of FSN-013
Fuji Pharma Co., Ltd. (Headquaters: Tokyo, Japan; “Fuji” below) and M3, Inc. (Headquaters: Tokyo, Japan; “M3” below) are pleased to jointly announce the acheivement of positive top-line results from the Phase-III clinical studies evaluating the Estetrol/Drospirenone combination product (“Product”, development code: FSN-013) for treatment of Japanese patients with dysmenorrhea or endometriosis.
The double-blind, placebo-controlled studies1 targeting patients with dysmenorrhea or patients with endometriosis are being performed to obtain an indication for the treatment of dysmenorrhea and pain associated with endometriosis in Japan. The Phase III study in patients with dysmenorrhea (Study No. FSN-013P-03) met its primary endpoint by demonstrating a statistically significant difference for the change in the total dysmenorrhea score when compared to placebo. The other Phase III study in patients with endometriosis (Study No. FSN-013P-04) also met its primary endpoint by demonstrating a statistically significant difference for the change in the Visual Analog Scale2 for the most severe pelvic pain (lower abdominal pain / back pain) when compared to placebo. Long term safety (52-week administration) continues to be evaluated for the Product.
Fuji obtained development and commercialization rights for the Product from Mithra Pharmaceuticals (Headquarters; Liege, Belgium). The Product contains the first native estrogen from fetal origin called estetrol (E4), which has been confirmed to selectively act on estrogen receptors. This selectivity of E4 is expected to provide a variety of benefits for patients.
As Fuji and M3 announced “Joint Development and Distribution Agreement for the FSN-013 (dysmenorrhea treatment agent) between M3 and Fuji” on November 12, 2020, Fuji and M3 agreed on the partnership for joint development and commercialization in Japan. Fuji and M3 will accelerate the development of the Product and aim at the launch in 2024 to provide patients with new treatment options by offering FSN-013 that contains estetrol, novel ingredient.