|Name/Company||Approval Dates and Comments|
Ingenol mebutate gel (0.015%, 0.05%)
Health Canada approved ingenol mebutate gel (derived from the Euphorbia peplus plant) in January 2013 for the topical treatment of actinic keratosis (AK). The 0.015% formulation is used once-daily on the face and scalp for 3 consecutive days, and the 0.05% gel is used once-daily on the trunk and extremities for 2 consecutive days. The treatment course may be completed in 2-3 days. In Phase 3 studies, 60-68% of patients with AKs on the face and scalp experienced ≥75% reduction of existing lesions vs. 7-8% with placebo; in treating AKs of the trunk and extremities 44-55% showed ≥75% reduction vs. 7% for placebo. Ingenol mebutate-treated patients experienced 37-47% complete clearance of lesions on the face and scalp and 28-42% on the trunk and extremities. The most common adverse events were local skin reactions, e.g., erythema, flaking/scaling, crusting and swelling. Potential ocular side effects following exposure include severe eye pain, eyelid edema, eyelid ptosis, and periorbital edema. US FDA approval was granted in January 2012.
Adapalene 0.1% + benzoyl peroxide 2.5% gel
The US FDA approved an expanded pediatric indication for Epiduo® gel in February 2013 to treat acne in children starting at 9 years-old based on the results of a recent clinical study in pediatric patients. The fixed-dosed combination anti-acne agent had been previously approved for patients ≥12 years of age. Side effects include skin burning sensation, irritation, discomfort dry kin, and erythema, which are comparable to study findings in patients aged ≥12 years of age.
Hydrogel for skin and wound care
Vashe® Skin and Wound Hydrogel
The FDA granted 510(k) marketing clearance in February 2013 to a new hydrogel formulation for the management and relief of pain, burning, and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis, as well as for the relief of dry waxy skin and pain from first- and second-degree burns.
Promising late stage data on apremilast (a phosphodiesterase 4 inhibitor) demonstrating safety and efficacy for moderate to severe chronic plaque psoriasis was presented in March 2013 at the American Academy of Dermatology’s 71st Annual Meeting in Miami, FL. The results were from ESTEEM 1, a randomized controlled trial involving 844 patients, which is the first of two Phase 3 studies for oral apremilast in psoriasis. The data showed that 33.1% of patients achieved PASI-75 at week 16 compared with 5.3% of placebo. Significantly higher PASI-75 scores at week 16 were reported across all patient populations, including systemicnaïve and biologic-naïve subjects receiving apremilast 30 mg twice-daily compared with placebo. Apremilast demonstrated sustained duration of benefit, as measured by the Mean Percent Change from Baseline in PASI score over 32 weeks, resulting in a 54.9% reduction at week 16 and a 61.9% reduction at week 32. Improvements were also evident in difficult to treat areas such as the scalp and nails, e.g., about 50% of patients achieved a 50% reduction in nail psoriasis severity.
Apremilast was generally well tolerated, and safety and tolerability were consistent with findings from previous Phase 3 trials in psoriatic arthritis (PsA). No cases of tuberculosis or lymphoma were reported through week 16 and no increased risk of cardiovascular events or serious opportunistic infection was observed. The most common adverse events (AEs) greater than placebo were diarrhea, nausea and headache; >96% of study patients reported either no or mild to moderate AEs.
Based on findings from both ESTEEM 1 and 2 studies for psoriasis, a submission to the US FDA is anticipated in the second half of 2013, with a separate New Drug Application filing for PsA expected in the first quarter of 2013. A combined PsA/psoriasis submission in Europe is targeted for the second half of 2013.