Contraception forecast: You’ll have new options

Just as you have integrated new methods such as the transdermal contraceptive and the contraceptive vaginal ring into your practice, be prepared to see more options added to the contraceptive mix.

Organon Pharmaceuticals of West Orange, NJ has submitted its application to the Food and Drug Administration (FDA) for the single-rod contraceptive implant Implanon. If approved, U.S. providers may see the device in 2004, says Nancy Alexander, PhD, director of contraception at Organon.

"The file has been submitted, and we are still contemplating the same time frame [of 2004]," she states.

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, women who do not tolerate or have contraindications to estrogens may safely use it.

In a three-year study investigating the contraceptive efficacy and tolerability of Implanon, findings indicate that the device was well tolerated and had excellent, reversible, contraceptive efficacy.1 Irregular bleeding was the primary reason for discontinuation (19.0%). Adverse events, other than bleeding irregularities, were generally mild to moderate in intensity and resulted in 9.3% of discontinuations.1 The most commonly reported nonbleeding adverse events were breast pain (16%), acne (12.6%), vaginitis (12%), and pharyngitis (10.5%).1 There is a rapid return to fertility in those women without fertility problems when the implant is discontinued.2

Bleeding disturbances are the main adverse events associated with implantable contraceptives.3 Other minor risks relate to the insertion and removal procedures, which require adequately trained providers as well as aseptic techniques.3 Provider education will be an important aspect of product introduction should Implanon receive FDA approval. Organon is developing educational models on insertion and removal techniques to ensure clinicians are familiar and comfortable with the device.

Where’s the sponge?

The Today Sponge, manufactured by Allendale (NJ) Pharmaceuticals, has been available over the counter in Canada for the past six months, reports Gene Detroyer, company president and chief executive officer. The FDA has made two inspections of the Norwich, NY, production plant to make sure the product meets export requirements, he adds.

"The inspections went well, as we were told the FDA will take no action to prevent us from continuing to export the product," Detroyer notes. "Further, Allendale was audited by the FDA to determine compliance with U.S. export/import laws, and we were found to be in compliance."

When will the company be cleared to sell the contraceptive sponge in the United States? The company is complying with all requests from the FDA; if all requirements are met, approval may come in spring of 2004, says Detroyer.

With the introduction of the extended regimen contraceptive Seasonale (Barr Laboratories, Pomona, NY), scientists are examining extended use of other contraceptives, including NuvaRing, Organon’s contraceptive vaginal ring.

"There is a continuous use trial with various regimens underway and so far, the results seem positive," says Ed Baker, MD, Organon’s associate director of contraception.

In a small pharmacokinetic study on the effects of the ring after extended use (five weeks vs. the conventional period of three weeks), findings indicate that ovulation continued to be inhibited, with no unfavorable safety observations.4

Researchers affiliated with Ortho-McNeil Pharmaceuticals in Raritan, NJ, also are looking at extending the current regimen of its transdermal contraceptive, Ortho Evra. Data are not yet available on extended use of the contraceptive patch.

On another contraceptive front, people still are asking for the Lunelle shot, says Theresa Rundell, ARNP, a nurse practitioner at the Klickitat County Health Department in White Salmon, WA. The monthly contraceptive injectable, with 25 mg medroxyprogesterone acetate and 5 mg estradiol cypionate, combines the convenience and efficacy of long-acting progestational methods with the cycle control and side effect profile of combined oral contraceptives.5

Pre-filled syringes of the product underwent a recall in 2002 when its manufacturer, Pharmacia Corp. of Peapack, NJ, discovered that the amount of medication in a small number of the syringes may have been insufficient to protect against pregnancy. The company subsequently discontinued production of the syringes and vials of the product.

Pharmacia merged with New York City-based Pfizer in 2003, so it is now up to Pfizer to determine if the product will return to the market. According to Daniel Watts, Pfizer media spokesman, Lunelle "is still not available on the market, and there are no immediate plans to bring it back to the market at this time."

References

1. Croxatto HB. Clinical profile of Implanon: A single-rod etonogestrel contraceptive implant. Eur J Contracept Reprod Health Care 2000; 5 Suppl 2:21-28.

2. Croxatto HB, Urbancsek J, Massai R, et al. A multicentre efficacy and safety study of the single contraceptive implant Implanon. Implanon Study Group. Hum Reprod 1999; 14:976-981.

3. Brache V, Faundes A, Alvarez F. Risk-benefit effects of implantable contraceptives in women. Expert Opin Drug Saf 2003; 2:321-332.

4. Mulders TM, Dieben TO. Use of the novel combined contraceptive vaginal ring NuvaRing for ovulation inhibition. Fertil Steril 2001; 75:865-870.

5. Shulman LP. Expanding contraceptive choices: Lunelle monthly contraceptive injection. Int J Fertil 2000; 45:190-194.