Pill options expand with new, generic OCs

As 2002 comes to a close, get ready to add a new lower-dose version of a popular oral contraceptive (OC) to your list of pills, and look to the upcoming 2003 introduction of a generic form of a long-time Pill favorite.

You should see Ortho Tri-Cyclen Lo from Raritan, NJ-based Ortho-McNeil Pharmaceutical now on retail market shelves, says Kellie McLaughlin, director of global pharmaceutical communications for New Brunswick, NJ-based Johnson & Johnson, Ortho-McNeil’s parent company. The pill, approved by the Food and Drug Administration (FDA) in August 2002, is a lower-dose form of Ortho Tri-Cyclen, the No. 1 prescribed birth control pill. (Read more about the drug in "Ortho Tri-Cyclen first low-dose OC to be indicated for noncontraceptive use," Contraceptive Technology Update, March 1997, p. 25.)

The new formulation provides a daily 25 mcg dose of estrogen for 21 days and three different doses of norgestimate (180 mcg daily/days 1-7; 215 mcg daily/days 8-14; 250 mcg daily/days 15-21). The last seven days contain no active ingredients.

Women are looking for a lower-dose pill, but one with excellent cycle control, says McLaughlin. Ortho Tri-Cyclen Lo offers such an option, she states.

In a multicenter study, researchers compared the contraceptive efficacy, cycle control, and safety of Ortho Tri-Cyclen Lo with another pill, Loestrin Fe 1/20 Loestrin (Pfizer, New York City).1 Contraceptive efficacy was comparable for the two pills; the overall and method failure probabilities of pregnancy through 13 cycles were 1.9% and 1.5%, respectively, with Ortho Tri-Cyclen Lo, and 2.6% and 2.4%, respectively, with Loestrin Fe 1/20. Breakthrough bleeding and spotting were reported by a significantly lower percentage of participants in the Ortho Tri-Cyclen Lo group compared with the Loestrin Fe 1/20 group. Compliance and safety data were similar for the two regimens.

Look at generic options

The past year has seen a number of generic OC choices added to the contraceptive options list. Barr Laboratories of Pomona, NY, a specialty pharmaceutical company engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, has introduced six generic products. Barr is set to debut its generic version of Ortho-McNeil’s Ortho 7/7/7 in January 2003, says Carol Cox, company spokeswoman. She says three more generic pills also may be introduced in the new year.

Following are the company’s 2002 additions, listed with their therapeutic equivalent products and manufacturers:

  • Kariva (Mircette, Organon, West Orange, NJ);
  • Lessina (Levlite, Berlex Laboratories, Montville, NJ);
  • Portia (Nordette, Monarch Pharmaceuticals, Bristol, TN; Levlen, Berlex Laboratories; Levora, Watson Pharmaceuticals, Corona, CA);
  • Enpresse (Triphasil, Wyeth-Ayerst, Philadelphia; Trivora, Watson; Tri-Levlen, Berlex Laboratories);
  • Cryselle (Lo-Ovral, Wyeth-Ayerst; Low Ogestrel, Watson);
  • Sprintec (Ortho-Cyclen, Ortho-McNeil Pharmaceutical).

The company previously introduced Apri, the therapeutic equivalent of Desogen (Organon) and Ortho-Cept (Ortho-McNeil) in 1999, and three products in 2001: Aviane (Alesse, Wyeth-Ayerst); Nortrel 1/25 (Ortho 1/35, Ortho-McNeil); and Nortrel 0.5/35 (Modicon-28, Ortho-McNeil).

The company plans to launch its generic version of the Ortho-Novum 7/7/7 pill in January 2003 operating under a nonexclusive license granted by Ortho-McNeil Pharmaceutical. The Barr Laboratories pill will be marketed under the name Nortrel 7/7/7.

Under the terms of an agreement reached in October 2001, Ortho-McNeil granted Barr a nonexclusive license effective Jan. 1, 2003, nine months before the patents protecting the product expire in September 2003. As part of the settlement, Barr acknowledged its infringement of, and the validity and enforceability of, the patent claims at issue in the case.

Is a four-periods-per-year pill on the horizon? The FDA accepted Barr Laboratories’ New Drug Application for its proprietary pill, Seasonale, in August 2002. The company also is researching a similar extended-period pill, dubbed DP3, in a current Phase III trial, says Cox.

Barr Laboratories, in agreement with the Medical College of Hampton Roads, Eastern Virginia Medical School in Norfolk, are developing the pill. (See article on Seasonale, "4-periods-per-year pill eyed for use in U.S. market," in CTU, May 1999, p. 51, and see "4-periods-per-year OC: Comparable to pill," August 2002 CTU, p. 87.)

The Seasonale regimen is designed to reduce the number of withdrawal bleeds from 13 to four per year. Under its regimen, women take the OC for up to 84 consecutive days, followed by seven days of placebo. This pill-taking regimen contrasts with the majority of oral contraceptives, which are based on a regimen of 21 treatment days, followed by seven days of placebo.

In a multicenter trial, two versions of the Seasonale extended oral contraceptive therapy prevented pregnancy comparable to study drugs.2 The adverse profile of the Seasonale drug was similar to that of other oral contraceptives, study findings indicate.2

References

1. Hampton RM, Short M, Bieber E, et al. Comparison of a novel norgestimate/ethinyl estradiol oral contraceptive (Ortho Tri-Cyclen Lo) with the oral contraceptive Loestrin Fe 1/20. Contraception 2001; 63:289-295.

2. Anderson FD. Results from a multicenter, open-label, Phase III study of Seasonale, a novel 91-day extended oral contraceptive (OC). Presented at the 50th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists. Los Angeles; May 2002.