Regulatory Decision Summary for Epsolay

The purpose of this New Drug Submission (NDS) was to obtain market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for Epsolay, filed by Searchlight Pharma Inc.

This submission was filed for Epsolay (benzoyl peroxide), cream, 5%, for topical use, for the treatment of: inflammatory lesions of rosacea in adults. Upon review of the submitted data package, Health Canada authorized Epsolay for the following indication: Epsolay (benzoyl peroxide cream) is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults.

Health Canada considers that the benefit-harm-uncertainty profile of Epsolay (benzoyl peroxide cream), 5%, is beneficial for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults.

The safety and efficacy of Epsolay was evaluated in two multi-center, randomized, double-blind, vehicle-controlled studies in patients with moderate to severe papulopustular rosacea (Study 1 and Study 2). The trials were conducted in 733 patients, aged 18 years and older. Patients were treated once daily for 12 weeks with either Epsolay or vehicle cream. In both trials, patients were randomized in a 2:1 ratio to receive either Epsolay or vehicle cream. Patients were required to have a minimum of 15 to 70 total inflammatory lesions (papules and/or pustules) and no more than 2 nodules (where a nodule was defined as a papule or pustule greater than 5 mm in diameter) and an Investigator Global Assessment (IGA) score of 3 (“moderate”) or 4 (“severe”) at baseline. Overall, 93% of patients were White and 73% were female, and the mean age was 51 years (ranged from 18 to 85 years). At baseline, patients had a mean inflammatory lesion count of 27.5, 89% were scored as moderate (IGA = 3) and 11% scored as severe (IGA = 4). The co-primary efficacy endpoints in both studies were the proportion of patients with treatment success at Week 12, defined as an IGA score of 0 (“clear”) or 1 (“almost clear”) with at least a two-grade reduction from baseline, and the absolute change from baseline in inflammatory lesion counts at Week 12. Epsolay was more effective than vehicle cream on the co-primary efficacy endpoints in both trials. In Study 1 and Study 2, respectively, 47.4% and 49.2% of the patients treated with Epsolay achieved an IGA success at Week 12 compared with 20.7% and 28.2% of the patients treated with vehicle cream. In both Study 1 and Study 2, a significantly greater reduction in least square mean inflammatory lesion counts from baseline was observed in patients treated with Epsolay (reductions of 17.4 and 20.3 inflammatory lesions in the respective studies) compared with those treated with vehicle cream (reductions of 9.5 and 13.3 inflammatory lesions in the respective studies). Epsolay demonstrated superiority to the vehicle cream, with greater reductions in inflammatory lesion counts and higher percentages of patients achieving an IGA success starting from Week 4.

The safety data showed that the most common adverse reactions which occurred in ≥ 1% of patients in Epsolay and with greater frequency than the vehicle cream included application site pain, application site erythema, application site pruritus, and application site edema. Overall, the safety review for Epsolay did not raise specific safety concerns beyond what is known for benzoyl peroxide. The safety concerns regarding Epsolay have been addressed through appropriate labelling in the Epsolay Product Monograph.

The final labelling and Product Monograph were considered acceptable.

Overall, the benefit-harm-uncertainty profile was favourable for Epsolay (benzoyl peroxide cream), 5%, for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

For further details about Epsolay, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.