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Goodbye Periods

Wyeth's low-dose combination oral contraceptive (OC) (Lybrel), indicated for the prevention of pregnancy in women desiring amenorrhea, received US Food and Drug Administration (FDA) approval. It is the first and only extended regimen OC that can be taken 365 days a year without a placebo or pill-free interval. Approval for the combination levonorgestrel 90 mcg/ethinyl estradiol 20 mcg OC was based on two 1-year clinical trials involving 2,457 women. Of the 860 women who finished all 13 pill packs 59% achieved amenorrhea, while 21% experienced breakthrough bleeding and/or spotting.

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Improving Hormone Therapy

Already approved at a higher dose, Novo Nordisk’s low-dose combination estradiol/norethindrone acetate (NETA) oral tablet (Activella) has received FDA approval for the treatment and prevention of moderate-to-severe menopausal symptoms and postmenopausal osteoporosis. The new low-dose treatment (estradiol, 0.5 mg/NETA, 0.1 mg) contains the lowest dose of the estrogen/progestin combination commercially available. Derived from natural plant hormones, the new dosage still supplements endogenous estrogen to relieve vasomotor symptoms within 3 to 4 weeks. It also prevents bone loss.

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Cooling Hot Flashes

The FDA has approved Upsher-Smith Laboratories, Inc’s, estradiol gel, 0.1% (Divigel), for the treatment of moderate-to-severe vasomotor symptoms in menopausal women. Available in three doses (0.25 mg/d, 0.5 mg/d, 1.0 mg/d), the new transdermal gel is the lowest dose of estradiol FDA-approved for the treatment of menopausal symptoms. Bioidentical to endogenous estrogen, the gel is self-administered by the patient on the thigh and is absorbed directly into the bloodstream.

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Treating Vaginal Infection

Approved in 2004 for the treatment of trichomoniasis, giardiasis, and amebic liver abscess, Mission Pharmacal Company’s tinidazole oral tablets (Tindamax) received FDA approval for a new indication: treatment of bacterial vaginosis (BV). The antiprotozoal drug is the newest FDA-approved oral therapy for BV in a decade. Tinidazole relieves BV symptoms by targeting the entire reproductive tract, focusing specifically on the upper region of the urinary tract where bacteria grows and migrates.

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Harnessing Heart Attacks

treatment of deep vein thrombosis, unstable angina, and non–Q-wave myocardial infarction (MI), sanofi-aventis has received expanded approval for its enoxaparin sodium injection (Lovenox) for the treatment of patients with acute ST-segment elevation MI when administered along with other standard therapy. In a series of clinical trials involving 20,000 patients, the antithrombotic low–molecular-weight heparin reduced the rate of mortality and recurrent heart attack by 17% compared with patients not receiving the enoxaparin sodium injection.

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