FDA Nod for Ortho Derm’s Acne Lotion Altreno

Friday, August 24, 2018 | FDA Approval/Clearance , Acne , Ortho Dermatologics


The U.S. Food and Drug Administration (FDA) approved the New Drug Application for Ortho Dermatologic’s Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in patients aged 9 and up. Altreno is expected to be available during the fourth quarter of 2018.

“Today’s FDA approval of Altreno builds upon our strong acne portfolio, providing physicians and patients a trusted retinoid in a lotion formulated to enhance the user’s experience with the inclusion of moisturizing attributes of hyaluronic acid, glycerin and collagen,” says Bill Humphries, president, Ortho Dermatologics, in a news release. “Altreno lotion spreads easily and is quickly absorbed into the skin allowing acne patients to easily incorporate this once-daily treatment into their skin care regimen.”

In clinical trials, Altreno lotion provided the proven efficacy of tretinoin in a generally well-tolerated formulation with skin dryness, pain, swelling, irritation and peeling reported in ≤4% of patients.

“Topical retinoids are a foundational treatment for all patients with acne, but they often cause skin irritation,” says Joshua Zeichner, M.D., director, Cosmetic and Clinical Research in Dermatology, The Mount Sinai Hospital, New York City. “With the efficacy expected from a retinoid, plus a proven tolerability profile, Altreno will be an ideal choice for many of my patients.”

Altreno was evaluated in two identical multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies, totaling 1,640 patients to determine its safety and efficacy. The data demonstrated that Altreno lotion resulted in statistically significant reductions in both inflammatory and non-inflammatory lesions compared to vehicle. In the population of patients treated in these studies, patients treated with Altreno saw a mean absolute reduction of 13.1 and 13.9 in inflammatory lesions in trials 1 and 2, respectively, compared to 10.6 and 10.7 in patients treated with vehicle. In addition, those treated with Altreno saw a mean absolute reduction of and 17.8 and 21.9 in non-inflammatory lesions in trials 1 and 2, compared to 10.6 and 13.9 in patients treated with vehicle. Also at Week 12, 16.5 percent and 19.8 percent of patients in trials 1 and 2, respectively, achieved treatment success (at least a 2-grade improvement in global severity by Evaluator Global Severity Scores and ‘clear’ or ‘almost clear’) with tretinoin 0.05% lotion, compared to only 6.9 percent and 12.5 percent with vehicle.

The most common adverse reactions occurring in >1 percent of subjects and greater than vehicle were dryness, pain erythema, irritation and exfoliation.  Sunscreen and protective clothing should be worn when sun exposure cannot be avoided.  Use Altreno with caution if allergic to fish due to potential for allergenicity to fish protein.

The clinical trial data also showed patient satisfaction (as assessed by 1,396 patient satisfaction surveys completed at Week 12) was significantly greater with Altreno lotion by Week 12, with patient satisfaction of those treated with Altreno lotion increased by 53 percent compared to 43 percent with vehicle (P<0.001). Nine out of 10 patients reported that they were satisfied with their treatment. Patients in the treatment group saw a statistically significant increase in mean Acne-QoL assessments compared to vehicle; increase in mean scores from baseline to Week 12 with Altreno were 7.4 (self-perception, versus 6.7 for vehicle, P=0.003), 6.8 (role-emotional, versus 6.0, P=0.003), 4.8 (role-social, versus 4.6, P=0.038) and 6.5 (acne symptoms, versus 5.6, P<0.001).

Next Story

Comments

You must be logged in to leave a comment.