Vyne Therapeutics Inc. (NASDAQ:VYNE) has completed its End-of-phase 2 Meeting with the US FDA. Also, the company announced the listing of another US patent of AMZEEQ® topical foam in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations.
VYNE files another patent for AMZEEQ
AMZEEQ is a topical foam, 4%, for treating inflammatory lesions in moderate-severed acne vulgaris in pediatric and adult patients. The patent, the company listed will expire on September 2037. The newly issued patent US. 10,849,847 is the company’s latest patent in connection with AMZEEQ. With the addition of the patent, there are now 12 patents listed for AMZEEQ in the FDA’s Orange Book.
David Domzalski, the company’s CEO said that they are committed to developing, extending, and consolidating their strong patent portfolio and they are delighted with the addition of the new patent. The patent offers more coverage of the company’s proprietary topical minocycline products for the treatment of moderate-severe acne vulgaris. Domzalski explained that VYNE’s patents are a testament to its innovative scientific approach to solving challenging therapeutic conditions in dermatology.
Most importantly, AMZEEQ is an antibiotic minocycline topical foam for treating red bumps and pimples that come with moderate-severe acne in patients above 9 years. AMZEEQ is for topical use and only available by prescription.
End-of-Phase 2 laying foundation for NDA for FCD105
Regarding the End-of-phase 2 meeting, the company has identified the primary elements of its phase 3 program supporting a New Drug Application for FCD105. It is important to note that FCD105 is a minocycline-based combination (3% minocycline/ 0.3% adapalene foam) product for treating moderate-severe acne vulgaris. The company supported the end-of-phase 2 meetings with non-clinical safety, CMC, and clinical data which included results of the previously completed Phase 2 study. In the phase 2 study, FCD105 showed efficacy in the co-primary endpoint measures of absolute change in inflammatory counts from baseline at week 12 and investigator’s Global Assessment treatment success.
Domzalski said that they are delighted with the End-of-phase 2 meeting outcome and the productive and collaborative guidance the FDA offered for the program.
