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Allergan today have confirmed that a new drug application for their 1% oxymetazoline hcl cream has been formally lodged with the FDA. The prediction from Allergan is that the approval will come in the first half of 2017.
This is the first confirmation that Allergan has settled on a 1% formulation of oxymetazoline hydrochloride, having tried several strengths during clinical trials. This proposed treatment for the redness of rosacea started development as V-101 owned by Vicept Therapeutics, and appears set to be given the name Azultro when approved. Update: This product will be known as Rhofade.
Oxymetazoline vs. Brimonidine
Allergan is subtly distancing itself from the brimonidine based Mirvaso by highlighting the potential chemical difference between oxymetazoline as a α1A-adrenoceptor and brimonidine as a α2-Adrenoceptor.
About Oxymetazoline
Oxymetazoline is a sympathomimetic agonist that is selective for the α1A-adrenoceptor over other α1-adrenoceptors and non-selective for the α2-adrenoceptors.
As such, oxymetazoline is a potent vasoconstrictor of the cutaneous microvasculature.
This difference makes sense, given that Allergan is unlikely to be developing another α2-Adrenoceptors with Mirvaso already existing as a product. The possible difference between the 2 types of receptor agonists, and the claim that oxymetazoline is gentler than brimonidine offers hope to rosacea sufferers that Azultro might prove to be an effective and tolerated rosacea treatment.
Press Release
05.24.2016 | Investors
Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0%
– Potential Treatment for Patients with Facial Erythema (Redness) Associated with Rosacea –
– Allergan Expects PDUFA Date in First Half 2017 –DUBLIN, May 24, 2016 /PRNewswire/ — Allergan plc (NYSE: AGN) today announced that the New Drug Application (NDA) filing for oxymetazoline HCl cream 1.0%, an investigational topical prescription product for the treatment of persistent facial erythema (redness) associated with rosacea in adults, has been accepted by the U.S. Food and Drug Administration (FDA) for standard review.
Allergan expects the Prescription Drug User Fee Act (PDUFA) date to be in the first half of 2017.
