More on the up-to-five-mornings-after pill

Doesn't really have the same ring to it, huh?

As we wait for the FDA to issue its ruling on Ella, the emergency contraceptive that can be taking with lasting efficacy up to five days after unprotected sex (the full FDA usually follows the recommendations of its advisory panels; the sub-committee on reproductive health approved the drug a few weeks ago), here's a brief Q&A between me and Christina Aplington, a PR exec for Ella-manufacturer HRA Pharma.

1) Will HRA Pharma push for over-the-counter status for Ella in the United States [Plan B, the existing emergency contracpetion in the US, is available over-the-counter]?

No, HRA Pharma submitted to the FDA an NDA for ella as a prescription emergency contraceptive.

2) What are the similarities and differences between ulipristal acetate and mifepristone in terms of their potential use as abortifacients? Does ulipristal acetate work as an abortifacient?

Emergency contraception still suffers from some widely held misconceptions. One of those is the systematic confusion between prevention and termination of a pregnancy. Ulipristal acetate has been developed for use as emergency contraceptive and tested during extensive clinical trials for this indication. All the results obtained confirm that it acts to prevent pregnancy the same way that regular birth control pills do, by inhibiting or delaying ovulation.

3)  What are the differences between ulipristal acetate and levonorgestrel, the chemical used in the Plan B emergency contraceptive?

Ulipristal acetate prevents pregnancies primarily by inhibiting or delaying ovulation. The compound has been shown to act at two levels: First, at the pituitary level, by inhibiting or delaying the luteinizing hormone surge; Second, at the ovarian level, by inhibiting follicular rupture even at a very late preovulatory stage, a time when existing hormonal emergency contraceptives are no longer effective.

4) Are you confident that you will receive FDA approval?

We are pleased with the outcome of the Advisory Committee votes on the safety and effectiveness of ulipristal acetate.  We look forward to working with the FDA to obtain approval for this new drug and offering a next generation emergency contraceptive to U.S. women.

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