Organon’s Implanon Is First Single-Rod Implantable Contraceptive
This article was originally published in The Pink Sheet Daily
Executive Summary
The etonogestrel implant will be available in conjunction with launch of Organon’s physician training program by the end of August.
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Organon's single-rod implantable contraceptive Implanon (etonogestrel), approved July 18, will be available at the end of August in conjunction with the start of the manufacturer-sponsored physician training program. "Organon USA will be sponsoring a national clinical training program to train healthcare providers on the insertion and removal procedures," the company said. "Only healthcare providers trained through the Organon-sponsored programs will be able to order Implanon." The three-hour physician training program will be taught by Organon-certified healthcare professionals. "As the training program progresses, Implanon will be more widely available in 2007," Organon said. The firm has also set up a website - 1 www.implanon-USA.com - and a telephone hotline - 1-877-IMPLANON - to disseminate information about the program. FDA's approval makes the implantable etonogestrel the "first and only single-rod implantable contraceptive that is effective for up to three years." The agency deemed Implanon "approvable" in November 2004 and again in June 2005, seeking additional information both times (2 (Also see "Organon's Implanon Contraceptive Gets Second "Approvable" Letter" - Pink Sheet, 22 Jun, 2005.)). Organon currently markets etonogestrel as a vaginal contraceptive ring, called NuvaRing . Women treated with Implanon in clinical trials experienced irregular bleeding. In studies, 35% of patients decided to stop Implanon use; 11% discontinued due to bleeding irregularities. Implanon's label includes a bolded warning in the "Warnings" section advising healthcare professionals to palpate the skin over the insertion site to ensure that the implant has been properly inserted, Center for Drug Evaluation & Research Division of Reproductive & Urologic Products Acting Director Scott Monroe said in a corresponding conference call. "This is critical for the product to be effective. If it can't be palpated the woman is advised not to depend on Implanon for prevention unless it can be localized by another method, such as ultrasonography or another procedure," Monroe said. Implanon will compete with Pfizer's injectable contraceptives, such as every-three-monthly Depo-Provera (medroxyprogesterone acetate). Organon's single-rod, matchstick-sized device could prove to be easier to manufacture and implant than Wyeth's six-rod Norplant (levonogestrel). Wyeth withdrew its three- to five-year implantable contraceptive Norplant in 2002, citing limitations in product component supplies (3 (Also see "Organon Predicts Implanon Launch In 2005 Following "Approvable" Letter" - Pink Sheet, 3 Nov, 2004.)). - Turna Ray |