Bayer has been given a green light in the EU to market Flexyess, a new extended use oral contraceptive that can be taken daily for up to 120 days.
Flexyess (drospirenone/ethinylestradiol) - which is also known as Yvidually - has been granted authorisation by the European Commission (EC) under its decentralised approval procedure and is expected to be cleared by national authorities in the EU in the coming weeks.
Bayer said it expects to launch the contraceptive in the second half of 2013, when it expects it to become "the first low-dose combined oral contraceptive approved in the EU member states for a flexible extended regimen".
The benefit of extended use contraceptives is that they allow women to control the timing and number of periods by selecting a tablet free interval at any time from day 25 to 120 of the treatment cycle.
Flexyess has been launched with an innovative digital tablet dispenser, called the Clyk, which Bayer says improves compliance with the regimen. The device not only reminds women when to take a dose, but also advises them what to do if they have missed one and warns if additional contraceptive cover is needed.
The product's route to regulatory approval was not without a hitch, however, with questions raised by some national authorities during the review period about the effectiveness of the extended use regimen, irregular bleeding episodes that might occur during the days of intake of the pill, and the fact that clinical trials of the product had not used the Clyk dispenser.
The Netherlands served as the rapporteur for the application but was forced to refer the dossier to the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) after it could not reach agreement with other EU member states. The CHMP issued a positive opinion on Flexyess in April.
The new product extends Bayer's already broad portfolio of oral contraceptives based on drospirenone and ethinyl estradiol, which also includes brands such as Yaz and Yasmin.
The franchise has been a big earner for Bayer but latterly has been hit by generic competition to some products and the addition of warnings on labelling in April in the US indicating that drospirenone-containing contraceptives may increase the risk of blood clots.