News from the FDA/CDC

FDA approves topical oxymetazoline for rosacea


 

A topical cream containing the vasoconstrictor oxymetazoline has been approved by the Food and Drug Administration to treat symptoms of rosacea, its manufacturer announced.

Oxymetazoline hydrochloride cream 1%, which will be marketed as Rhofade by Allergan, is indicated for the treatment of “persistent facial erythema associated with rosacea in adults.” While nasal sprays containing a lower concentration of oxymetazoline HCl, an alpha1A-adrenoceptor agonist, have been used off label for a decade, this is the first time this ingredient has been harnessed to formulate an approved rosacea treatment.

In a press statement, Allergan cited results from two vehicle-controlled trials in which 885 adults with moderate to severe rosacea (79% female, 90% white) were randomized to treatment with oxymetazoline HCl or a vehicle cream for 29 days. At day 29, 12%-18% of patients in the active treatment arms had a 2-grade or better improvement from baseline (measured day 1, before the first dose) 3-12 hours after applying the medication, compared with 5%-9% for the vehicle cream arms. Outcomes were measured using combined patient and clinician erythema assessment scales.

Safety results from three pooled trials showed 2% of patients in the active treatment arms (489 people) had treatment-site dermatitis, and 1% had worsening of rosacea symptoms, pruritus, or pain. The vehicle cream groups (483 people) experienced similar rates of pruritus but negligible rates of other adverse effects, according to the prescribing information.

Brimonidine (Mirvaso) is another topical treatment approved by the FDA for treating rosacea, and its active ingredient is also an alpha-adrenergic agonist that works on the cutaneous microvasculature. However, there are differences in the two agents’ activity. Oxymetazoline acts on alpha1A receptors and brimonidine on alpha2 receptors. There have been reports of rebound erythema more severe than at baseline with brimonidine, and its manufacturer, Galderma, acknowledges the phenomenon in patient labeling.

When Allergan announced the FDA application for oxymetazoline in May 2016, it issued a press statement, describing oxymetazoline as a “sympathomimetic agonist that is selective for the alpha1A adrenoceptor or over other alpha1 adrenoceptors and nonselective for the alpha2 adrenoceptors.”In a 1-year open label trial of oxymetazoline (440 people), 3% of patients had worsening inflammatory lesions of rosacea, according to the prescribing information for oxymetazoline HCl 1%.

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