Esmya: new pre-operative treatment option for uterine fibroids

Esmya (ulipristal acetate) has been launched for the pre-operative treatment of moderate to severe symptoms of uterine fibroids in women of reproductive age.

The active ingredient of Esmya, ulipristal acetate, is also licensed for use as an emergency contraceptive (EllaOne)
The active ingredient of Esmya, ulipristal acetate, is also licensed for use as an emergency contraceptive (EllaOne)

PHARMACOLOGY

Ulipristal acetate is an orally-active synthetic progesterone receptor modulator with a tissue-specific partial progesterone antagonist effect. It exerts a direct action on fibroids, reducing their size by inhibiting cell proliferation and inducing apoptosis.1

CLINICAL STUDIES

In the PEARL I study, women with symptomatic fibroids, excessive uterine bleeding and anaemia were randomised to receive daily treatment for up to 13 weeks with ulipristal acetate 5mg (n=96), 10mg (unlicensed dose; n=98) or placebo (n=48). All patients received oral iron supplementation.2

At 13 weeks, control of uterine bleeding was observed in 91% of women receiving the 5mg dose, 92% of those receiving the 10mg dose and 19% of those on placebo (p<0.001 for both doses vs placebo). Amenorrhoea was reported in 73%, 82% and 6% of women respectively, and occurred within 10 days in the majority of those who received ulipristal acetate. Fibroid volume decreased with ulipristal acetate 5mg and 10mg but increased slightly with placebo: median changes of -21%, -12% and +3%, respectively.2

In the non-inferiority PEARL II study, 307 women with symptomatic fibroids and excessive uterine bleeding were randomised to receive 3 months of daily therapy with ulipristal acetate (5mg or 10mg) or monthly intramuscular injections of leuprorelin (3.75mg).3

At 13 weeks, uterine bleeding was controlled in 90% of patients receiving 5mg ulipristal acetate, 98% of those receiving 10mg ulipristal acetate and in 89% of those receiving leuprorelin. Median times to amenorrhoea were 7 days with 5mg ulipristal acetate, 5 days with 10mg ulipristal acetate and 21 days with leuprorelin. Moderate to severe hot flushes were more common with leuprorelin than ulipristal acetate (p<0.001).3
 
References

1. Esmya Summary of Product Characteristics, February 2012.
2. Donnez J et al. N Engl J Med 2012; 366: 409-20.
3. Donnez J et al. N Engl J Med 2012: 366: 421-32.

View Esmya drug record

Further information: Preglem


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