Costas Papaellinas Organization is pleased to announce the launch of the new emergency contraception medicine EllaOne® manufactured by HRA Pharma France.

EllaOne® was approved in May 2009 by the European Union with the indication: emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. It is the only product licensed for this indication.

Its active ingredient, Ulipristal acetate, is a synthetic progesterone receptor modulator and its primary mechanism of action is inhibition or delay of ovulation. Alterations to the endometrium may also contribute to the efficacy of the product (delay in maturation, decrease in endometrial thickness).

On a large head to head study published at ‘The Lancet’ including over 2.000 women comparing ellaOne® with levonorgestrel, the trial shows that a single dose of ellaOne® significantly reduces the number of pregnancies versus the number of expected pregnancies in the absence of emergency contraception, and that efficacy is sustained over 5 days after unprotected intercourse. The study also shows that ulipristal acetate is well tolerated with a safety profile similar to that of levonorgestrel.

The Lancet also reports on a meta-analysis of two similar studies which includes nearly 3.500 women. ‘Upon meta-analysis of the two datasets combined, rate of pregnancy was lower in the ulipristal acetate group than in the levonorgestrel group when emergency contraception was taken within 24h, 72h, or 120h after sexual intercourse. If emergency contraception was used within 24h of unprotected sexual intercourse, the risk of pregnancy was reduced by almost two thirds compared to levonorgestrel.’

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