Allergan/Gedeon Richter's uterine fibroids drug succeeds in Phase 3
Allergan and Gedeon Richter's uterine fibroid treatment ulipristal acetate, has succeeded in a phase 3 trial ahead of a planned US filing next year.
The companies announced positive results from Venus I, one of two pivotal phase 3 trials evaluating efficacy and safety of ulipristal acetate in women with uterine fibroids.
Gedeon Richter markets the drug in Europe under the brand name Esmya following approval in 2012, but this is the first completed pivotal trial to succeed in a US population that meets requirements of the US Food and Drug Administration. Bayer is also developing a rival drug, vilaprisan, which is in Phase 2 development.
The Venus I study included 157 patients, with 101 randomised to ulipristal acetate 5mg and 10mg and 56 to placebo.
It met all the co-primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over placebo.
The co-primary efficacy endpoints were percentage of patients with absence of uterine bleeding and time to absence of uterine bleeding. Significantly more patients in the 10 mg group (58.3%) and the 5 mg group (47.2%) achieved absence of bleeding compared to placebo.
The secondary efficacy endpoints were the percentage of patients with absence of uterine bleeding from Day 11 to end of treatment and the change from baseline in a health-related quality of life questionnaire at the end of treatment.
There were no treatment-related serious adverse events and no patients discontinued ulipristal acetate treatment due to adverse events. The most common adverse events on ulipristal acetate were hypertension, blood creatine phophokinase increased, hot flush and acne.
The companies are planning a US regulatory filing early in 2017, after the announcement of results from the second phase 3 trial, Venus 2.
A selective progesterone receptor modulator, ulipristal acetate exerts a direct effect on the endometrium by suppressing uterine bleeding and direct action on fibroid size by decreasing the formation of new fibroid cells and promoting fibroid cell death. The drug is also used in HRA Pharma's ellaOne "morning after pill", but at a higher dose.