Magazine article Drug Topics

After a Long Wait, Ortho Debuts New Oral Contraceptive

Magazine article Drug Topics

After a Long Wait, Ortho Debuts New Oral Contraceptive

Article excerpt

Nearly three years after its approval by the Food & Drug Administration, Ortho-Cyclen, a new oral contraceptive, has finally reached the market. The product, developed by Ortho Pharmaceutical Corp., was introduced last month.

A "combination" OC, OrthoCyclen contains estrogen in the form of ethinyl estradiol and a new progestin called norgestimate. At the time of its approval in December 1989, a 1990 launch was planned (Drug Topics, Jan. 22, 1990). However a patent dispute with American Home Products Corp. delayed the product's introduction, Ortho spokeswoman Clare Castaldo told Drug Topics. Distribution of Ortho-Cyclen began in October, shortly after an injunction against its sale was lifted, she added.

FIRST IN 20 YEARS: Norgestimate is "the first new progestin to enter the American market in more than 20 years," according to Ortho. Although the company makes that point, it will say little else about the new Pill. Castaldo said that Ortho-Cyclen's labeling is similar to that of other drugs in its class; Ortho "really can't differentiate" the new progestin from others contained in OCs.

But Clayton McCracken, medical director of InterMountain Planned Parenthood in Billings, Mont., believes that norgestimate may offer an advantage or two over other progestins currently used in the Pill. The new compound may be less likely to cause androgen-related adverse reactions, such as acne or hirsutism, he said. In addition, unlike some older progestins, norgestimate should not lower high-density lipoprotein--or "good cholesterol"--levels.

Norgestimate "is one of the progestins that has been available in Europe for quite some time," McCracken remarked. "Those of us who are working in the field of family planning are really glad that we're finally getting these progestins into the United States."

OrthoCyclen is a "monophasic" OC, meaning that patients receive the same dose of estrogen and progestin each day for 21 consecutive days. Each active tablet contains 35 mcg of ethinyl estradiol and 0.25 mg of norgestimate. In contrast, patients taking "biphasic" or "triphasic" OCs progress through two or three dosage levels during each cycle of use; the tablets provide a different ratio of estrogen to progestin at specific intervals.

In McCracken's opinion, the type of OC a patient receives depends on the prescriber's preference rather than any particular patient characteristic. …

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