dm+d

Unassigned

New Medicines

Twirla Contraception in women with a body mass index <30kg/m2. 7-day transdermal patch formulation

Information

Twirla
New formulation
Agile Therapeutics, Inc
Agile Therapeutics, Inc

Development and Regulatory status

None
None
Launched
Dec 20Agile state in their 2019 annual report that they may seek partners for commercialisation of Twirla outside of the US [4].
Feb 20Twirla is launched in the US as a method of contraception for use in women of reproductive potential with a Body Mass Index <30 kg/m2 [3].

Category

Monophasic patch preparation of combined ethinylestradiol 30mcg/day+levonorgestrel 120mcg/day for once weekly delivery, i.e. three patches per cycle (for 21 days) and one-week off
75% of women aged 16-49 years use some type of contraception; 25% of women use the combined oral contraceptive pill (COCP) [1].
Contraception in women with a body mass index <30kg/m2. 7-day transdermal patch formulation
Transdermal

Trial or other data

Dec 20Published PIII Study (n=2,032) reports levonorgestrel/ethinylestradiol (three consecutive administrations of 7-day patches followed by 7 days off) was effective in preventing pregnancy; number of unintended pregnancies i.e. Pearl Index (95% CI) was 5.8 (4.5-7.5) pregnancies per 100 woman-years [2].

Evidence based evaluations