Open-label Extension Study Evaluating Long-term Safety and Efficacy of FMX101 4% Minocycline Foam for Moderate-to-Severe Acne Vulgaris.

This study sought to evaluate the long-term safety and efficacy of FMX101 4% topical minocycline foam for the treatment of moderate-to-severe acne. This was an open-label extension of two double-blind studies, Study 04 and Study 05. Subjects were enrolled at 35 sites in the United States and one site in the Dominican Republic.

Topical minocycline foam 4%: Results of four phase 1 studies evaluating the potential for phototoxicity, photoallergy, sensitization, and cumulative irritation.

FMX101 4% contains 4% micronized minocycline (as an HCl) formulated in a lipophilic foam vehicle for topical administration. FMX101 4% has been shown to be an effective and well-tolerated treatment for moderate-to-severe acne in three Phase 3 pivotal studies, however, skin sensitization and toxicity potential remains to be fully evaluated. Four single-center, randomized, controlled, within-subject comparison studies were conducted to evaluate the potential for phototoxicity, photoallergy, skin sensitization, and cumulative skin irritation with topical administration of FMX101 4% and the corresponding vehicle.

A novel topical minocycline foam for the treatment of moderate-to-severe acne vulgaris: Results of 2 randomized, double-blind, phase 3 studies.

Background: FMX101 4% is a topical minocycline foam for the treatment of moderate-to-severe acne.

Objective: Evaluate the efficacy and safety of FMX101 4% in treating moderate-to-severe acne vulgaris.

Methods: Two identical phase 3 studies were conducted.

Pharmacokinetic Comparison of Once-Daily Topical Minocycline Foam 4% vs Oral Minocycline for Moderate-to-Severe Acne.

Objective: To characterize minocycline pharmacokinetics and relative bioavailability following multiple-dose topical administration of minocycline hydrochloride (HCl) foam 4% (FMX101 4%) as compared with single-dose oral administration of minocycline HCl extended-release tablets (Solodyn®) in subjects with moderate-to-severe acne.

Methods: A Phase 1, single-center, nonrandomized, open-label, active-controlled, 2-period, 2-treatment crossover clinical study. The study included 30 healthy adults (mean age, 22.

Norethindrone acetate 1.0 milligram and ethinyl estradiol 10 micrograms as an ultra low-dose oral contraceptive.

Objective: To assess the efficacy, safety, and tolerability of an extended-duration, combined hormonal oral contraceptive pill (OCP) that reduces the estrogen exposure by almost half compared with other OCPs.

Methods: This open-label, uncontrolled, multicenter study used an ultra low-dose OCP (1.0 mg norethindrone acetate and 10 micrograms ethinyl E2).

Efficacy and safety of a new 24-day oral contraceptive regimen of norethindrone acetate 1 mg/ethinyl estradiol 20 micro g (Loestrin 24 Fe).

Background: New low-dose formulations of combination oral contraceptives (COCs) are safe and effective, but they may be associated with an increased risk of breakthrough bleeding. Extending the duration of active hormonal treatment may reduce the frequency of intracyclic bleeding/spotting while maintaining efficacy and tolerability.

Methods: This 6-month, open-label, randomized, active-controlled study involved healthy women aged 18-45 years who were at risk for pregnancy.

Effects of low-dose norethindrone acetate plus ethinyl estradiol (0.5 mg/2.5 microg) in women with postmenopausal symptoms: updated analysis of three randomized, controlled trials.

Background: Based on the potential risks of post-menopausal hormone therapy (HT) found by the Women's Health Initiative, guidelines for HT now recommend use of the lowest effective dose and shortest treatment duration consistent with individual treatment goals. Current (2003) guidance established by the US Food and Drug Administration (FDA) recommends that clinical assessments of HT include women with more frequent and more intense vasomotor symptoms than previously studied. Therefore, this analysis was conducted to further assess the efficacy of a low-dose combination of norethindrone acetate and ethinyl estradiol (NA/EE) previously assessed in dose-ranging studies, while meeting conservative FDA trial design and analysis criteria.

Efficacy of a new, oral estradiol acetate formulation for relief of menopause symptoms.

Objective: To determine the efficacy of three doses of a new, oral formulation of estradiol acetate (EA) for alleviation of vasomotor and urogenital symptoms in postmenopausal women.

Design: Two separate 12-week studies were undertaken in postmenopausal women with moderate to severe vasomotor symptoms. In the first study, women were randomly assigned to EA 0.

Comparative controlled trial of a novel oral estrogen therapy, estradiol acetate, for relief of menopause symptoms.

Objective: To compare the efficacy and tolerability of a new oral estradiol prodrug, estradiol acetate, with micronized estradiol or conjugated equine estrogens for alleviation of postmenopausal vasomotor and urogenital symptoms.

Design: A total of 249 postmenopausal women experiencing seven or more moderate or severe vasomotor symptoms daily for 1 week or 60 or more symptoms in 1 week were randomized to 0.9 mg of estradiol acetate (n = 79), 1 mg of micronized estradiol (n = 85), or 0.