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Claims for Patent: 8,426,392

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Claims for Patent: 8,426,392

Title:Method for providing emergency contraception
Abstract: The invention provides a method for providing emergency contraception in a female subject, comprising providing the subject with a therapeutically effective amount of ulipristal acetate in an oral dosage form before, during or after a meal. The invention further provides a kit comprising i) an oral dosage form comprising ulipristal acetate and ii) a printed matter stating that ulipristal acetate may be taken with or without food.
Inventor(s): Gainer; Erin (Paris, FR), Mathe; Henri Camille (Paris, FR)
Assignee: Laboratoire HRA-Pharma (Paris, FR)
Application Number:12/633,885
Patent Claims: 1. A method for providing emergency contraception in a female subject, comprising the step of administering to the subject after unprotected intercourse a therapeutically effective amount of ulipristal acetate ranging from about 20 mg to about 30 mg in an oral dosage form with food.

2. The method of claim 1 wherein the ulipristal acetate is administered before or after food ingestion.

3. The method of claim 1 wherein the food has a high fat content.

4. The method of claim 1 wherein the oral dosage form is a tablet.

5. The method of claim 1 wherein the dosage form comprises 30 mg ulipristal acetate.

6. The method of claim 1, wherein ulipristal acetate is administered to the subject within 72 hours after unprotected intercourse.

7. The method of claim 1, wherein ulipristal acetate is administered simultaneously with food ingestion.

8. The method of claim 1, wherein the oral dosage form is a tablet comprising from 3% to 18% by weight of ulipristal acetate, from 60% to 95% by weight of a diluent, from 1% to 10% by weight of a binding agent, from 1% to 5.5% by weight of croscarmellose sodium and 1% to 4% by weight of magnesium stearate.

9. The method of claim 1, wherein the administration of ulipristal acetate with food results in an about 40-45% decrease in mean C.sub.max, an about 20-25% increase in mean AUC.sub.0-.infin. and a delayed median t.sub.max by at least about 1.5 hours as compared with administration of ulipristal acetate without food.
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