The FDA’s Office of Prescription Drug Promotion has flagged promotional communications from Mayne Pharma regarding its Nextstellis combined hormonal contraceptives (CHCs), as the Australia-based women’s health company looks to close its buyout deal with Cosette Pharmaceuticals.
First reported by Fierce Pharma, a letter from the agency dated April 28 says that Mayne’s speaker deck makes false or misleading claims and presentations about the risks of Nextstellis, creating a “a misleading impression about the risks a patient may experience as a result of using Nextstellis in comparison to other estrogen-containing CHCs, and minimizes the risks associated with Nextstellis.”
The letter goes on to point out that Mayne makes a “misleading suggestion” that the estrogen contained in Nextstellis is safer compared to other CHCs, and misleadingly minimizes the risk of breast cancer, when in fact, Nextstellis is contraindicated in patients with a current diagnosis or history of breast cancer.
Nextstellis was approved in April 2021 with a boxed warning regarding increased risks of serious cardiovascular events from cigarette smoking and combined hormonal contraceptives. The drug has several contraindications, including patients with high risk of arterial or venous thrombotic diseases or current or history of a hormonally-sensitive malignancies.
In February 2025, Cosette Pharmaceuticals announced that it will acquire all outstanding shares of Mayne Pharma Group for a total consideration of approximately $430 million. The deal is expected to close in the second quarter of 2025.