VYNE Therapeutics Announces FDA Approval of AMZEEQ (Minocycline) Label Update

AMZEEQ label update includes new information indicating the low propensity of Propionibacterium acnes (more commonly known as “P. acnes”) to develop resistance to minocycline

BRIDGEWATER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced approval by the U.S. Food and Drug Administration (“FDA”) to include new information in the product label for AMZEEQ (minocycline) topical foam, 4% referencing the low propensity of P. acnes strains to develop resistance to minocycline, the active ingredient in AMZEEQ. AMZEEQ is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older.

Specifically, the FDA-approved AMZEEQ label now provides that with respect to resistance, P. acnes strains displayed a low propensity for the development of resistance to minocycline, with spontaneous mutation frequencies occurring <10⁻⁸ (or 1 in 100 million) at 2 to 16 times the minimum inhibitory concentration (MIC). The update to the microbiology section in the label further states that although the clinical significance is unknown, the active ingredient in AMZEEQ (minocycline), is proven to be active in vitro against most isolates of P. acnes.

“The risk of antimicrobial resistance is a primary concern for dermatologists or, indeed, any routine prescriber of antibiotics,” said David Domzalski, CEO of VYNE. “We are pleased that the inclusion of this valuable additional information for AMZEEQ will support prescribers in making informed decisions on both their choice of antibiotic and administration route when selecting a treatment for acne.”

The FDA approval was supported by an extensive antimicrobial characterization program by VYNE for both AMZEEQ and minocycline that was published last year in the peer-reviewed journal Anaerobe.¹ The program evaluated the on-target potency of AMZEEQ and minocycline against P. acnes and further evaluated the potential for the development of minocycline-resistant strains that could reduce the potency of AMZEEQ in the treatment of acne.

“Both dermatologists and payors have had keen interest in antimicrobial resistance data as they balance patient care with antibiotic stewardship,” said Matt Wiley, Chief Commercial Officer for VYNE. “We believe the label update will be well-received.”