FDA Policy/General

FDA Hits Mayne Nextstellis Professional Presentation

The CDER Office of Prescription Drug Promotion (OPDP) says a professional presentation for Mayne Pharma’s Nextstellis (drospirenone and estetrol tablets) for oral use makes false or misleading claims and presentations about the drug’s risks. A 4/28 Untitled Letter says the presentation speaker slide deck “creates a misleading impression about the risks a patient may experience as a result of using Nextstellis in comparison to other estrogen-containing combined hormonal contraceptives (CHCs) and minimizes the risks associated with Nextstellis. The speaker deck is particularly concerning given that Nextstellis is associated with some serious and potentially life-threatening risks, including a Boxed Warning regarding increased risk of serious cardiovascular events from cigarette smoking and CHC use.”

The letter lists Nextstellis’ Contraindications, Warnings, and Precautions from the labeling and the most common adverse reactions. OPDP notes it sent advisory comments to Mayne in 2022 and says it is “concerned that Mayne is promoting Nextstellis without presenting the serious risks of the drug in a truthful and non-misleading manner, despite OPDP’s prior comments.”

The letter says the presentation includes misleading claims and presentations suggesting that Nextstellis, because of its active estrogen ingredient, estetrol, is safer than other forms of CHCs, including those that contain ethinyl estradiol, when this has not been demonstrated. It devotes several pages to outlining the violative claims and presentations.

Mayne was told to list all promotional communications for Nextstellis that contain the same or similar claims and presentations and to submit a plan for the timely discontinuation of such communications or for stopping the distribution of Nextstellis.

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