FDA to Review Topical Rosacea Treatment

The NDA is supported by two Phase 3 clinical trials
The NDA is supported by two Phase 3 clinical trials

Allergan announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for oxymetazoline HCl cream 1% for the treatment of persistent facial erythema associated with rosacea in adults.

Rosacea is a chronic, inflammatory disorder that requires long-term treatment to alleviate symptoms and delay or prevent disease progression. It is not curable, with limited topical treatment options available for associated symptoms such as persistent facial redness. 

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The NDA submission for oxymetazoline 1% cream was supported by data from two 29-day Phase 3 clinical trials and a 1-yr open label trial in adults with moderate to severe persistent facial erythema associated with rosacea. Allergan expects the Prescription Drug User Fee Act (PDUFA) date for completion of the NDA review to be in the first half of 2017.

Oxymetazoline, a sympathomimetic agonist, is selective for the α1A-adrenoceptor over other α1-adrenoceptors and non-selective for the α2-adrenoceptors. It exhibits potent vasoconstriction of the cutaneous microvasculature.

For more information call (800) 433-8871 or visit Allergan.com.

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