The European Commission has given the thumbs-up to Bayer’s new contraceptive combo Flexyess.
The German company notes that Flexyess (drospirenone/ethinylestradiol) will be the first low-dose combined oral contraceptive approved in the EU member states for a flexible extended regimen. The combo offers women the option of "personal period planning", Bayer adds, meaning they can choose both the number and timing of their periods according to their needs.
Flexyess has proven to be effective in preventing pregnancy in clinical studies involving over 2,500 women aged 18-45 years, the Leverkusen-headquarted group notes. It was shown to have an overall safety profile comparable to other oestrogen/progestin-containing oral contraceptive combos.
Flexyess comes with an innovative digital tablet dispenser, Clyktm, which Bayer says is expected to improve adherence because it not only reminds women when to take their pill, but also advises them what to do if they have missed one. It also warns them if additional contraception is needed.
Bayer added that first launches of the product in the European Union are expected in the second half of 2013.