Regulatory Decision Summary for Rosiver

Based on two pivotal, randomized, placebo-controlled Phase 3 studies, Rosiver 1% cream applied to the face once daily for 1 year or longer, has been shown to effectively treat papules and pustules in subjects with moderate to severe inflammatory rosacea. This outcome was confirmed in a Phase 3 active-controlled study where Rosiver 1% cream was shown to be statistically superior to a current standard therapy, topical metronidazole. A total of 2047 subjects were exposed to the to-be-marketed formulation and regimen.

The treatment emergent adverse event (TEAE) profile for all 10 studies performed in subjects with moderate to severe inflammatory rosacea showed that Rosiver cream 1% is safe and well tolerated for short-term and long-term treatment of adult subjects. The safety profile remained stable over conditions of long-term use up to 1 year as observed in the clinical studies.

Clinical local tolerance studies that evaluated ROSIVER cream 1% applied once daily showed low contact sensitization potential and low cumulative irritancy potential for the active formulations and for the vehicle, which was consistent with the results of the nonclinical local tolerance studies. The TEAE profiles for the studies indicate that ROSIVER is well tolerated with little evidence of application-site irritation. The occurrence of suspected local allergic reactions that were considered related to study drug by the Investigators in 2 of 2163 subjects (approximately 0.1%) exposed to ROSIVER cream 1% indicates that the potential for sensitization reactions after application of the product is low. The occurrence of one case of moderate sunburn reaction considered related to Rosiver by the Investigator, in 2431 subjects exposed at least once to Rosiver cream 1%, indicates a low incidence (0.04%) of potential sunburn reactions after application of the product.

Routine blood chemistry and hematology assessments were performed in the studies. No unusual trends were observed in any treatment group in comparative studies of up to 16 weeks of treatment, or in the long-term extensions of the Phase 3 pivotal studies.

The safety data from the Sponsors studies, in conjunction with the long international history of clinical experience with marketed oral and topical products containing the active ingredient ivermectin (for example, Stromectol, Sklice), support the safe use of Rosiver (ivermectin cream, 1%) for the proposed indication.

For more information on Health Canadas decision, please view the Summary Basis of Decision.