FDA Approves Pump Dispenser of Differin GelThe FDA has approved the pump dispenser for Differin (adapalene) Gel, 0.3%, a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years and older, from Galderma Laboratories, LP Differin Gel, 0.3% is the most dispensed brand of topical retinoid among dermatologists. The metered pump container allows patients to consistently apply a proper amount of medication without any waste.
Galderma reports that a recently completed preference survey, which involved 291 physician-diagnosed acne patients aged 12 to 35 years, showed a strong patient preference for a pump delivery system of an adapalene-containing acne product versus a tube. Acne patients found the pump to be more convenient, easier to use, and more attractive than the tube. Specifically, 79% of acne patients responded that they preferred the new pump delivery system over a tube; 92% of acne patients rated their experiences as "satisfied" with the pump delivery system; 88% of acne patients said the pump made it easier for them to follow their doctor's instructions; and more than 90% of acne patients found that the pump delivered a consistent amount of product to their faces during each use and saved time during treatment administration.
The efficacy and tolerability of Differin Gel, 0.3% over tazarotene gel, 0.1% and tretinoin gel microsphere, 0.04% has been shown in a number of studies reported by Galderma. In a Phase 3b, 12-week, non-inferiority, multicenter, investigator-blinded, controlled clinical study of 172 patients aged 12 to 35 years with acne vulgaris, adapalene was found to be non-inferior to tazarotene gel, 0.1% at the end of 12 weeks.
In a satisfaction survey of 160 patients, Differin Gel, 0.3% was found to offer comparable lesion reduction compared to tazarotene gel 0.1% throughout 12 weeks and superior tolerability compared to tazarotene gel, 0.1% throughout the 12 weeks. In addition, cutaneous tolerability scores were lower with Differin Gel, 0.3% versus tazarotene gel, 0.1% for all parameters (erythema, scaling, dryness, and stinging/burning), and 86% of patients were satisfied or very satisfied with Differin Gel, 0.3% treatment.
Finally, in a single-center, randomized, investigator-blinded, bilateral (split-face) comparison of 30 healthy subjects aged 18 years or greater, subjects received Differin Gel, 0.3% on one-half of the face and tretinoin gel microsphere, 0.04% on the other half for 21 days. The results showed that after 5 days of treatment, 59% of patients preferred the overall tolerability of Differin Gel, 0.3% versus 41% of patients with tretinoin gel microsphere, 0.04%.
FDA and Pliaglis
Nuvo Research Inc. has announced that the FDA has accepted the supplemental New Drug Application (sNDA) for Pliaglis for review. The sNDA was submitted by Galderma Laboratories, LP, the US subsidiary of Galderma Pharma S.A. (Galderma). Nuvo has licensed worldwide marketing rights for Pliaglis to Galderma, a global pharmaceutical company specializing in dermatology. The FDA has set a PDUFA (Prescription Drug User Fee Act) date of April 16, 2012 for action on the submission.
Pliaglis is an FDA-approved topical local anesthetic cream that provides local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal. Pliaglis was initially approved by the FDA in June 2006, but was voluntarily removed from the US market by Galderma in 2008 due to manufacturing issues at Galderma's third-party contract manufacturer. Galderma subsequently transferred Pliaglis manufacturing to Galderma and has resolved the manufacturing issues. Galderma and Nuvo believe that the sNDA addresses the manufacturing site change and the resolution of the manufacturing issues. Galderma plans to launch the marketing and sale of Pliaglis in the United States in the second half of 2012.
DARA and Bionect
DARA BioSciences, Inc. has announced an exclusive agreement with Innocutis Holdings, LLC ("Innocutis") for U.S. commercial rights to Bionect® (hyaluronic acid sodium salt, 0.2%) within the oncology and radiation oncology markets. Bionect is FDA-approved for the treatment of skin irritation—a well-documented side effect of radiation and chemotherapy treatment—as well as first- and second-degree burns. Bionect is currently being promoted and sold by Innocutis in the dermatology market. DARA expects to launch Bionect in the second quarter of 2012.