Phase III trial meets primary endpoint for Allergan’s fibroid treatment
pharmafile | May 9, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | Allergan, fibroid, phase 3, phase III, ulipristal, ulipristal acetate, uterine fibroid
Allergan (NYSE: AGN), in collaboration with Gedeon Richter, has announced positive results from a pivotal Phase III trial evaluating the efficacy and safety of ulipristal acetate in women with uterine fibroids.
Also known as myomas, uterine fibroids are the most common benign tumours that affect up to 80% of women in the US by the age of 50. It is the leading cause of hysterectomies in the country and costs the economy over $34 billion each year. Symptoms of the disease often include abnormal uterine bleeding, passing clots, pelvic pain and abdominal distortion.
Ulipristal acetate exerts a direct effect on the endometrium, suppressing uterine bleeding, and direct action on fibroid size by decreasing the formation of new fibroid cells and promoting fibroid cell death.
In the late-stage trial, which included 157 patients, 101 received the drug with the rest getting placebo. The study met its primary and secondary endpoints with ulipristal achieving statistically significant results over placebo. Between 47.2% and 58.3% achieved absence of bleeding compared to placebo. Participants also recorded higher results in a disease-specific symptom and health-related quality of life questionnaire.
David Nicholson, president of global R&D at Allergan, says: “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.”
This trial, called VENUS I, is the first clinical trial to on the drug to report topline results. The second, VENUS II, is expected to publish results in the first half of 2017, with a new drug application expected to be filed for ulipristal acetate for the treatment of uterine fibroids sometime that year.
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