​Allergan Plc and Gedeon Richter Plc. today announced positive results from Venus I, one of two pivotal Phase 3 clinical trials evaluating the efficacy and safety of ulipristal acetate in women with uterine fibroids. 

 

The study included 157 patients, with 101 patients randomized to ulipristal acetate 5 and 10 mg and 56 to placebo. The study met all the co-primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over placebo (p<0.0001). 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%; p<0.0001) and the 5 mg group (47.2%; p<0.0001) achieved absence of bleeding compared to placebo (1.8%).

 

“We are pleased with the positive efficacy and safety results demonstrated in this clinical trial.   Uterine fibroids are the leading cause of hysterectomies in the US.  Ulipristal acetate has the potential to offer the first and only non-invasive long-term treatment option for women suffering from uterine fibroids in the US,” said David Nicholson EVP and President of Global R&D, Allergan.

 

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 the UFS-QOL revised Activities subscale at the end of treatment.  Significantly more patients in the 10 mg group (58.3%; p<0.0001) and the 5 mg group (43.4%; p<0.0001) achieved absence of bleeding from Day 11 to the end of treatment compared to placebo (0%). The improvement from baseline in the UFS-QOL revised Activities subscale was significantly greater in the 10 mg group (59.0; p<0.0001) and the 5 mg group (52.1; p<0.0001) compared to placebo (21.2).  

 

The UFS-QOL is a disease-specific symptom and health-related quality of life questionnaire. This questionnaire is an established instrument to assess disease impact on patient’s well-being in women with uterine fibroids.

 

“We are delighted with this significant step forward for ulipristal acetate as it confirms and underlines that it could provide medical therapy to many women suffering from this condition,” said Dr. István Greiner, Research Director of Gedeon Richter Plc. “We remain committed to the development of women healthcare products which improve quality of life for the female population in all age groups.”

 

There were no treatment-related serious adverse events. No patients discontinued ulipristal acetate treatment due to adverse events. The most common adverse events (≥ 5%) on ulipristal acetate treatment were hypertension (N=6), blood creatine phosphokinase increased (N=5), hot flush (N=5), and acne (N=3).  

 

Venus I is the first clinical trial to report topline results. The second of two clinical trials—Venus II—is anticipated to be completed this year with topline results expected in the first half of 2017.  A new drug application for the treatment of uterine fibroids is planned to be submitted in 2017.

 

 

This study was a multi-center, randomized, double-blind, placebo-controlled clinical trial in premenopausal women between 18 and 50 years old with cyclic (22 to 35 days) abnormal uterine bleeding in ≥4 of the last 6 menstrual cycles, menstrual blood loss ≥80 mL as measured by the alkaline hematin method over the first 8 days of menses, ≥1 discrete uterine fibroid of any size and location observable by transvaginal ultrasound, follicle-stimulating hormone ≤20 mIU/mL, and uterine volume ≤20 weeks by exam.  Eligible patients were randomized 1:1:1 to ulipristal acetate 5 mg, 10 mg or placebo for one 12-week treatment course followed by a 12- week treatment-free follow-up period. African-American women represented 69% of patients enrolled. The average BMI was 31.7.

 

The Venus I trial, is the first completed pivotal study of ulipristal acetate for uterine fibroids in the US population. It is designed to meet FDA requirements for approval. 

 

 

Source: Allergan