Foam Treatment Approved for Rosacea
Azelaic acid foam, 15% (Finacea, Bayer HealthCare) received FDA approval for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. The approval is based on results from 2 pivotal clinical trials examining the efficacy and safety of the azelaic acid foam, 15% compared to its foam vehicle in the topical treatment of papulopustular rosacea. Papulopustular rosacea is a skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.
In 2 pivotal clinical trials, treatment with azelaic acid foam, 15% resulted in a higher Investigator’s Global Assessment success rate compared to vehicle control (32.1% vs 23.4% in trial 1 and 43.4% vs 32.5% in trial 2, respectively), as well as a greater reduction in the mean nominal change of inflammatory lesion count from baseline to the end of the 12-week treatment period (−13.2 vs −10.3 in trial 1 and −13.3 vs −9.5 in trial 2, respectively). The most frequently observed adverse reactions in ≥0.5% of subjects treated with the foam included local application site pain (6.2%), pruritus (2.5%), dryness (0.7%) and erythema (0.7%).
The product will be available by prescription only beginning in September 2015.
BBC Drug Gains Approval
Sonidegib (Odomzo Capsules, Novartis Pharmaceuticals Corporation) has been approved by the FDA for the treatment of patients with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. The recommended dose and schedule for sonidegib is 200 mg orally once daily taken on an empty stomach, at least 1 hour before or 2 hours after a meal.
The approval was based on demonstration of a durable objective response rate (ORR) in an international, multicenter, double-blind, randomized, 2-arm, non-comparative trial in patients with laBCC not amenable to local therapy or metastatic BCC, according to the FDA.
The clinical trial enrolled 230 patients who were randomized 2:1 to receive sonidegib 800 mg (N=151) or 200 mg (N=79) daily until disease progression or unacceptable toxicity. Randomization was stratified by disease stage (locally advanced or metastatic), histologic subtype (aggressive or non-aggressive) and geographic region. Eight-four percent of those enrolled had locally advanced disease. Among patients with laBCC randomized to receive sonidegib 200 mg daily, the median age was 67 years; 58% were male, 89% were white, 67% had an Eastern Cooperative Oncology Group performance status of 0 and 3 patients had nevoid BCC syndrome. Seventy-six percent of patients had received prior therapy for treatment of BCC and approximately half of these patients (56%) had aggressive histology.
The ORR for the 66 patients with laBCC randomized to the sonidegib 200 mg arm was 58% (95% confidence interval [CI], 45, 70], consisting of 3 (5%) complete responses and 35 (53%) partial responses. A prespecified sensitivity analysis using an alternative definition for complete response, defined as at least a partial response according to magnetic resonance imaging and/or photography and no evidence of tumor on biopsy of the residual lesion, yielded a complete response rate of 20%. A similar response rate was noted in the 128 patients with laBCC randomized to the sonidegib 800 mg arm (44%; 95% CI, 35, 53). Among the 38 responding patients with laBCC in the 200 mg arm, 7 patients (18%) experienced subsequent disease progression, and 4 of these 7 patients had maintained a response of 6 months or longer. The remaining 31 patients (82%) continue to respond with ongoing responses ranging from 1.9+ to 18.6+ months; 16 patients have ongoing responses of 6 months or longer, and the median duration of response has not been reached.
Serious and common adverse reactions and discontinuation of sonidegib for adverse reactions occurred more frequently in the 800 mg treatment arm. Adverse reactions occurring in more than 10% of patients treated in the 200 mg arm were muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting and pruritus. The most frequent grade 3 and 4 laboratory abnormalities occurring in at least 5% of patients in the 200 mg arm were serum lipase and creatine kinase elevations.
The most serious risks of sonidegib are rhabdomyolysis and embryofetal toxicity.
Healthcare professionals should verify pregnancy status prior to the initiation of sonidegib, counsel pregnant women on the potential risks to the embryo and fetus and advise non-pregnant women to use effective contraception during treatment with sonidegib and for at least 20 months after the last dose based on the 28-day half-life of sonidegib. To avoid the potential risk of exposure to sonidegib that may be contained in semen, male patients should use condoms during treatment with sonidegib, and for at least 8 months after the last dose, according to the FDA.
Injectable Gets Approval for Volume Loss in Cheek Area
The injectable Restylane Lyft (Galderma) received FDA approval for cheek augmentation and the correction of age-related mid-face contour deficiencies in patients over the age of 21. The product, formerly marketed as Perlane-L, is an injectable gel used to increase volume and smooth wrinkles in the face. With this new indication, it is the first and only FDA approved filler indicated to provide fullness to the mid-face area (cheeks) and to correct and smooth the nasolabial folds.
“Achieving natural-looking lift in the cheek area is one of the most common requests that I receive from my patients,” said Robert Weiss, MD, principal investigator of the clinical trial and director of MD Laser, Skin and Vein Dermatology and clinical associate professor of dermatology at the University of Maryland. “Restylane Lyft is a versatile product that has a long, proven history of providing safe, precise and predictable results. The results of this clinical trial show that it can provide an effective option for patients when they desire lift — not just volume — in their cheeks.”
In a clinical trial involving 200 patients, investigators observed that 88.7% of patients treated with the injectable showed an improvement in fullness in the right and left mid-face areas (combined) at 2 months, and more than half maintained improvement for 12 months. Additionally, 95% of patients reported improvement with the appearance of their mid-face at 2 months and 73% of patients reported improvement at 12 months. The most common adverse events observed in the trial included tenderness, redness, bruising, swelling and itching. These events decreased in severity over time and most were resolved within 2 weeks.
New Acne Treatment Option Approved
Adapalene and benzoyl peroxide gel 0.3%/2.5% (Epiduo Forte, Galderma) received FDA approval for the once-daily, topical treatment of acne vulgaris. It is the first combination of these strengths of the retinoid, adapalene and benzoyl peroxide, developed for the moderate to severe acne population.
The approval was based on a pivotal Phase III, multicenter, randomized, double-blind, 12-week, vehicle-controlled study in which it met each of its primary efficacy endpoints when compared to vehicle gel in 217 acne patients. The study demonstrated superiority of the adapalene and benzoyl peroxide gel 0.3%/2.5% over vehicle gel in the overall study population (moderate to severe) at week 12 for the Investigator’s Global Assessment success rate and for changes in inflammatory and non-inflammatory lesion count.
Additionally, patients who were “severe” at baseline (50%) were required to go from “severe” to “clear” or “almost clear” within the 12-week trial to be considered a treatment success. More than half of patients treated with adapalene and benzoyl peroxide gel 0.3%/2.5% reported a marked improvement in their severe acne (50.5%).
In the clinical trial, adapalene and benzoyl peroxide gel 0.3%/2.5% was shown to be safe and well-tolerated, and most adverse events were mild to moderate in severity, which is important for acne patients with sensitive skin. The most commonly reported adverse events (≥1%) in patients treated with the gel were skin irritation, eczema, atopic dermatitis and skin burning sensation. As an antibiotic-free acne treatment that was well-tolerated in clinical trials, the gel can be considered for long-term use and is available in a pump with once-daily dosing, according to Galderma. The gel will be available by prescription in early September 2015.
Scar Management Gel Available
The prescription scar management gel Celacyn (IntraDerm Pharmaceuticals), is now available. The gel received FDA clearance as a prescription product in December 2014.
The dimethicone (modified silicone) based gel contains Microcyn Technology (stabilized hypochlorous acid/HOCl) and is used post-procedure for scar management treatment. It is intended for the management of old and new hypertrophic and keloid scars resulting from burns, general surgical procedures and trauma wounds.
A double-blind, multicenter study evaluated the efficacy and tolerability of the prescription scar management gel as compared to Kelo-cote in up to 40 adult patients with hypertrophic or keloid scars. Qualified scars included linear or widespread hypertrophic scars and keloids treated 3 times a day for 8 weeks. The age of the target scars was in between 3 months, at a minimum, to 1 year, at a maximum. There were no adverse events related to the products.1
“The scar hydrogel delivered significant improvement in all endpoints assessed, including reduction of pain and itch,” says Zoe Diana Draelos, MD, one of the investigators in the FDA study required for 510(k) clearance. “Positive results across the board were seen in our comparator clinical study.” For more information regarding the rebate program, please visit http://www.intraderm.com/rebates/.
1. Bucko AD, Draelos Z, Dubois JC, Jones TM. A double-blind, randomized study of a Microcyn® Technology scar gel in comparison with 100% silicone gel for hypertrophic or keloid scars. Poster presented at: 10th Annual Coastal Dermatology Symposium; September 24-27, 2014; Sonoma, CA.
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