Allergan Launches Taytulla, a Soft Gel Capsule Oral Contraceptive
Allergan has launched Taytulla, an estrogen/progestin combination oral contraceptive, in a 1-mg/20-mg capsule form. It is the first and only oral contraceptive on the market that comes in a soft gel capsule form. The capsules will be commercially available in blister cards holding 24 soft gelatin capsules, each containing 1 mg of norethindrone acetate and 20 mcg of ethinyl estradiol, as well as 4 nonhormonal placebo capsules containing iron.
Taytulla is indicated for use by females to prevent pregnancy. In a clinical study consisting of 743 women between 18 and 45 years of age, Allergan assessed the safety and efficacy of the norethindrone acetate/ethinyl estradiol tablets. Participants were examined for up to six 28-day cycles, providing researchers with 3823 treatment cycles to gauge. Out of this total, there were 5 on-treatment pregnancies in those who did not use backup contraception.
The most common adverse effects associated with Taytulla are headaches, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.
"As a leader in women's healthcare, we are pleased to bring to market Taytulla, the first and only oral contraceptive in a soft gel capsule, providing women with an important new and effective option to consider with their healthcare providers," said Bill Meury, Chief Commercial Officer at Allergan, in a press release. "The patented soft gel 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 is not recommended in patients with uncontrolled hypertension, or hypertension with vascular disease.