Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA announced that the novel oral contraceptive NEXTSTELLIS ® (3 mg drospirenone and 14.2 mg estetrol (E4) tablets) has been granted marketing exclusivity as a new chemical entity (NCE) from the US Food and Drug Administration (FDA). The exclusivity runs for five years from FDA approval of the New Drug Application for NEXTSTELLIS. NEXTSTELLIS was approved by the FDA in April 2021 and is the first and only pill containing E4, a natural estrogen produced during pregnancy that is now made from a plant source.

E4 is the first new estrogen introduced in the US in more than 50 years. A new article has been published in Contraception - an international, peer-reviewed reproductive health journal - with the results of the NEXTSTELLIS North American Phase III clinical study involving nearly 2,000 women. The publication concluded that NEXTSTELLIS is an effective oral contraceptive with a predictable bleeding pattern for most women and a low rate of adverse events.

In addition to efficacy and safety, a predictable bleeding pattern is another key consideration for women and their healthcare providers. Bothersome breakthrough bleeding is a common side effect of hormonal contraception and can often lead to discontinuation of contraceptives. Unscheduled bleeding occurred in less than 2% of patients after cycle 2 (bleeding only) with less than 1 day of unscheduled bleeding or spotting on average per cycle after cycle 1.