WYETH TRIPHASIL ORAL CONTRACEPTIVE WITH VARYING ESTROGEN/PROGESTOGEN

Executive Summary

WYETH TRIPHASIL ORAL CONTRACEPTIVE WITH VARYING ESTROGEN/PROGESTOGEN levels will be in drug-stores by Dec. 1, the company stated in a Nov. 8 press release announcing FDA approval of the drug Nov. 1. Triphasil is the third triphasic oral contraceptive to receive FDA approval. Ortho's Ortho Novum 7/7/7 and Syntex' Tri-Norinyl were both approved in April. Wyeth's product differs from the other two by varying the levels of both estrogen and progestrogen components. The first dosage phase of Triphasil contains 30 mcg estrogen and .05 mg progestrogen, the second phase contains 40 mcg estrogen and .075 mg progestogen, and the third phase contains 30 mcg estrogen and .125 mg progestogen. The Ortho and Syntex products maintain a constant 35 mcg estrogen concentration and vary the progestogen component. For instance, the Ortho product varies in progestogen from 0.5 mg the first week to 0.75 mg the second week and 1 mg the third week, with the fourth week drug free. Wyeth noted in its release that Triphasil's "total estrogen dose is the lowest among all phasic products and its progestogen level is at least 38.9% lower than that of any other combination birth control pill now on the market." The company maintained that the other two triphasic products on the market "are not new but in large part combinations of dosage strengths found in previously marketed pills." Wyeth also pointed out that "unlike other triphasics, which utilize a Sunday start regimen, Triphasil," which is initiated on the first day menstruation begins, "requires no additional method of contraception during the first month when used as directed." Triphasil is priced to pharmacists at $29.64 for a three month supply of three compacts and $58.08 for six compact refills.