The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for clascoterone cream 1% for the treatment of acne.

Clascoterone, a potential first-in-class topical androgen receptor inhibitor, targets androgen receptors at the application site, inhibiting the local effects of dihydrotestosterone, a key driver of acne lesion development. 

The NDA includes data from two phase 3 trials that showed treatment with clascoterone was associated with a statistically significant improvement in all primary end points (success rate in Investigator’s Global Assessment [IGA], change from baseline in non-inflammatory lesion counts, change from baseline in inflammatory lesion counts).

As for safety, results from an open-label study showed no hormonal imbalance with clascoterone even after long-term treatment or when used on an enlarged application surface. Dermal adverse events associated with therapy included erythema/reddening on the face and trunk and scaling/dryness on the face.

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“We look forward to working closely with FDA during the review process. If approved, clascoterone cream 1% will be the first new mechanism of action in the treatment of acne in nearly 40 years, offering dermatologists and patients a new and effective therapeutic alternative,” said Diana Harbort, CEO of Cassiopea.

The FDA has set a Prescription Drug User Fee Act action date of August 27, 2020 for the application.

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