Allergan plc, a leading global pharmaceutical company, announced the availability of Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules), 1mg/20mcg, the first and only oral contraceptive in a softgel capsule for the prevention of pregnancy.
"As a leader in women's healthcare, we are pleased to bring to market Taytulla, the first and only oral contraceptive in a softgel capsule, providing women with an important new and effective option to consider with their healthcare providers," said Bill Meury, chief commercial officer at Allergan. "The patented softgel technology of Taytulla was designed with absorption and solubility in mind, contains 20 mcg of estrogen, and offers women pregnancy prevention with short, light periods."
Taytulla will be commercially available in blister cards containing 24 oval, opaque, pale pink (active) soft gelatin capsules, each containing 1 mg norethindrone acetate and 20 mcg ethinyl estradiol, and 4 oval, opaque, maroon (nonhormonal placebo) capsules containing iron.
In a clinical study, 743 women 18 to 45 years of age were studied to assess the efficacy of norethindrone acetate/ethinyl estradiol tablets, for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure. A total of 583 women completed 6 cycles of treatment. There were a total of 5 on-treatment pregnancies in 3,565 treatment cycles during which no backup contraception was used. The Pearl Index for norethindrone acetate/ethinyl estradiol capsules was 1.82 (95% CI: 0.59-4.25).
Taytulla is an estrogen/progestin combination oral contraceptive (COC) indicated for use by females of reproductive age to prevent pregnancy. Efficacy in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.
In the clinical trial for Taytulla, the most common adverse reactions (incidence =2%) were headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.