FDA Approves Ulipristal Acetate Tablets for Prescription Emergency Contraception

2010-08-20

FDA Approves Ulipristal Acetate Tablets for Prescription Emergency Contraception

ROCKVILLE, Md -- August 16, 2010 -- The US Food and Drug Administration (FDA) has approved ulipristal acetate (ella) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (5 days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.

Ulipristal acetate is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. Since May 2009, the prescription product has been available in Europe (under the brand name ellaOne).

An FDA Advisory Committee for Reproductive Health Drugs discussed ulipristal acetate in June 2010. The committee unanimously voted that the application for ulipristal acetate provided compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception.

The safety and efficacy of ulipristal acetate were demonstrated in 2 phase 3 clinical trials. One study was a prospective, multicentre, open-label, single-arm trial conducted in the United States; the other was a randomised, multicentre, single-blind comparator-controlled trial conducted in the United States, the UK, and Ireland.

Side effects most frequently observed with ulipristal acetate in the clinical trials included headache, nausea, abdominal pain, dysmenorrhea, fatigue, and dizziness. The profile of side effects for ulipristal acetate is similar to that of FDA-approved levonorgestrel emergency contraceptives.


SOURCE: US Food and Drug Administration