Organon has won approval in the USA for its implantable contraceptive Implanon, more than 18 months after the Food and Drug Administration issued an ‘approvable’ letter for the product.
US approval comes eight years after Implanon (etonorgestrel), a contraceptive implant that is inserted under the skin of the upper arm and protects against pregnancy for up to three years, was first cleared for marketing in Europe. It is already available in over 30 countries and has been used in 2.5 million women.
Toon Wilderbeek, head of pharmaceuticals at Organon parent company Akzo Nobel, said the product is the first and only single-rod implant and “represents an advance in contraceptive technology.”
Contraceptive implants have had a tough time breaking into the US market, with just over 1% of American women using this type of product, according to data from the Guttmacher Institute. One barrier has been the negative publicity surrounding the first rod-based implant, Wyeth’s Norplant, which was removed from the market in 2000. Wyeth claimed supply problems was the reason, but it had also suffered a slew of lawsuits brought by women who claimed the six-rod product was hard to remove and caused scarring and other side effects.
To guard against any such problems, Organon USA will be conducting a national clinical training programme to train healthcare providers on the insertion and removal procedures, and only healthcare professionals trained through the sponsored programmes will be able to prescribe Implanon.
The clinical training program is scheduled to begin later this year and, as the training program progresses, Implanon will become more widely available during the course of 2007.
Since Norplant’s demise, almost all implantable contraceptive use in the USA takes the form of injections such as Pfizer’s Depo-Provera (medroxyprogesterone acetate), which provides around three months’ protection per shot.