Menlo Therapeutics In (NASDAQ:MNLO) FDA approved topical foam, AMZEEQ, for treating inflammatory moderate to a severe non-nodular lesion in adults, with acne vulgaris, as well as children above nine-year has been included in the prescription drug formulary of one of US’s largest payors. The topic foam received approval from the FDA for the treatment of acne last year.
AMZEEQ available to acne vulgaris patients in the US
David Domzalski, the CEO of Menlo, stated that the company was delighted with its ongoing expansion of AMZEEQ national coverage. David added that following the additional plan under the agreement, the topical foam now has coverage of almost 60% of the US’s total commercial lives. The CEO added that this was a huge milestone that will enhance access for AMZEEQ across the US to several patients having moderate to several acne.
Minocycline, which is a wide spectrum antibiotic that is popular for its efficacy in the treatment of moderate to severe acne, was previously not available in the form of a topical treatment. This is because of the instability in conventional topical foams. However, AMZEEQ Foamix has employed the patented Molecule Stabilizing Technology platform in delivering minocycline via a foam-based delivery that ensures the active ingredient is stable when delivering it directly on the skin.
Limitations of AMZEEQ and safety warnings
The AMZEEQ topical foam 4% (minocycline) is indicated for moderate to severe acne vulgaris, but there are limitations for use. So far, the minocycline formulation is yet to be evaluated in treating infections. Therefore to minimize the development of drug-resistant bacteria as well as enhance the effectiveness of antibacterial drugs, AMZEEQ has to be used as indicated.
Most importantly, when using AMZEEQ, one should avoid direct sunlight or things such as tanning beds or sunlamps. AMZEEQ is not good for people that are allergic to minocycline or tetracycline, and if there is an allergic reaction, usage should be halted immediately. Expectant ladies should not use this formulation, and if one gets pregnant using the formulation, they need to talk to their doctor.