Ask the Experts: Contraceptive implant, sponge await FDA action
Contraceptive implant, sponge await FDA action
What is the U.S. market status for two forms of birth control, the single-rod contraceptive implant and the contraceptive sponge? Answers to these questions are provided by Marcia Diljak, spokeswoman for West Orange, NJ-based Organon, and Gene Detroyer, president and chief executive officer of Allendale (NJ) Pharmaceuticals.
Question: I want to attend the Contraceptive Technology April 2005 preconference on progestin-only implants, but my agency won’t allow me to attend unless there is a new method approved by the Food and Drug Administration (FDA). What is the status of Implanon?
Diljak: As of Contraceptive Technology Update deadline, Implanon still is in approvable status at the FDA.
The FDA issued an approvable letter for the single-rod implant in November 2004. According to the FDA, an approvable letter signals that the agency is prepared to approve the product dependent on the company meeting specified conditions.
Implanon is inserted under the skin of the upper arm and provides contraception for up to three years. Consisting of a nonbiodegradable rod measuring 40 mm in length and 2 mm in diameter, the device releases the progestin etonogestrel at an average release rate of 40 mcg per day. Since the device does not contain estrogen, it may be safely used by women who do not tolerate or are contraindicated to estrogen use.
Progestin-only implant contraception options have been lacking since the 2000 removal of the six-rod Norplant implant from U.S. pharmacy shelves. Wyeth Pharmaceuticals, Madison, NJ, suspended shipment of implants in August 2000 when concerns arose about efficacy of suspect lots. While the lots were found effective in July 2002, the manufacturer chose not to reintroduce the product in the United States.
Although the Norplant contraceptive system was highly effective and convenient, the removal challenges associated with the six-rod system proved to be a major downside for many, says Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center/Jacksonville. Implanon would address these challenges.
Question: What is the U.S. status of the Today Contraceptive Sponge?
Detroyer: Allendale Pharmaceutical recently received labeling approval from the FDA. As of CTU press time, the company awaits further action as to full marketing status.
The sponge was released in the Canadian market in 2003; in the last year and a half, the company has sold more than 500,000 sponges with no reports of an adverse event or unplanned pregnancy.
Women have waited for news of the sponge’s re-emergence on U.S. market shelves; some 250 million sponges were sold between Today’s 1983 market debut and its 1995 removal.
The sponge was not removed from the market by the FDA; its former manufacturer, Whitehall-Robins Healthcare of New York City, ceased production when it determined it cost too much to correct problems caused by water quality issues at the old factory where the sponge was made. Allendale Pharmaceuticals acquired manufacturing and marketing rights to the sponge in 1999 and has been working with the FDA to have updated labeling and manufacturing approved for the over-the-counter contraceptive. The Today Sponge is circular in shape, 2 inches in diameter and three-fourths of an inch thick, with an attached loop. Made of polyurethane, it contains 1,000 mg of the spermicide nonoxynol-9.
What is the U.S. market status for two forms of birth control, the single-rod contraceptive implant and the contraceptive sponge? Answers to these questions are provided by Marcia Diljak, spokeswoman for West Orange, NJ-based Organon, and Gene Detroyer, president and chief executive officer of Allendale (NJ) Pharmaceuticals.Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.