Benzinga | Dec 7, 2020 07:14AM EST

Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug Application for Twyneo for the Treatment of Acne Vulgaris

Sol-Gel Technologies, Ltd. (NASDAQ:SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that its New Drug Application (NDA) for Twyneo(r) (benzoyl peroxide and tretinoin), an investigational proprietary fixed-dose combination of 3% encapsulated benzoyl peroxide and 0.1% encapsulated tretinoin cream for the treatment of acne vulgaris, has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for Twyneo is August 1, 2021.

The NDA filing is based on two positive pivotal Phase 3 randomized, double-blind, multicenter, 12-week, clinical trials that evaluated the safety and efficacy of Twyneo compared to vehicle in patients 9 years of age and older with moderate-to-severe acne vulgaris (N = 858). In both trials, Twyneo demonstrated statistically significant improvement in all co-primary endpoints in the treatment of patients with acne vulgaris of (i) the proportion of patients who succeeded in achieving at least a two grade reduction from baseline and Clear (grade 0) or Almost Clear (grade 1) at Week 12 on a 5-point Investigator Global Assessment (IGA) scale, (ii) an absolute change from baseline in inflammatory lesion count at Week 12 and (iii) an absolute change from baseline in non-inflammatory lesion count at Week 12. The most common adverse events were local reactions, such as pain, dryness, exfoliation, erythema, dermatitis, pruritus and irritation, with nearly all adverse events (AEs) being mild or moderate in severity and no treatment-related serious AEs.

Acne vulgaris is a multifactorial disease that is often treated with a combination of drugs. Twyneo combines two active ingredients that have a complementary mechanism of action in a compelling once-daily treatment.

"This is another important milestone achieved on time by Sol-Gel, in addition to the previous acceptance for filing by the FDA of Epsolay in papulopustular rosacea," commented Dr. Alon Seri-Levy, Chief Executive Officer of Sol-Gel. "We are proud that by using our proprietary microencapsulation technology we have managed to overcome the instability of tretinoin when combined with benzoyl peroxide. If approved, Twyneo has the potential to provide relief for many of the approximately 40-50 million people in the United States who suffer from acne vulgaris."