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news.HRA Pharma has reported that key clinical results of its recently-approved emergency contraceptive, ellaOne (ulipristal acetate), have been published in the February issues of two scientific journals, The Lancet, and Obstetrics & Gynecology.
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The reports capture the results of a broad-scale international clinical development program designed to evaluate the efficacy of ulipristal acetate, HRA Pharma’s progesterone receptor modulator, as a method of emergency contraception.
Engineered and sponsored by the company, the trials were carried out in partnership with leading reproductive health experts in Europe and the US. It involved 33 investigators and 80 clinics, with more than 4,000 women participating in the trials. The product was approved by the EU in May 2009, and has since been launched under the trademark, ellaOne, in 17 countries.
Erin Gainer, CEO of HRA Pharma, said: The publication of this clinical data enables us to share our research results with the scientific community, as well as recognise our strong network of partners that were involved in seeing this program through to fruition. It is also a testament to HRA Pharma’s commitment to designing therapeutic solutions that satisfy critical patient needs in reproductive health, and our ability to successfully bring these solutions to market.
“We will continue to pursue strategic R&D opportunities and partnerships with this mission in mind tailored projects having the potential to enable women to take greater control of their own health.”
The company designed and developed ulipristal acetate for use as an emergency contraceptive. ellaOne can be taken for up to five days after unprotected sexual intercourse, and is the only product licensed for this indication.
HRA Pharma plans to register the product in countries worldwide. The company continues to explore potential applications for ulipristal acetate in additional areas of reproductive health, and the compound is currently undergoing clinical trials for the treatment of uterine fibroids.