14 February 2019 | News
LEXETTE received approval from the US Food and Drug Administration (FDA) in May 2018 with three years of marketing exclusivity.
image credit- thehealthsite.com
Mayne Pharma Group Limited has announced the launch of LEXETTE™ (halobetasol propionate) Foam 0.05% in the United States.
LEXETTE, the conditionally-acceptable trade name for halobetasol foam is a new formulation of halobetasol, a potent topical corticosteroid indicated for the treatment of plaque psoriasis in adult patients. LEXETTE received approval from the US Food and Drug Administration (FDA) in May 2018 with three years of marketing exclusivity.
Plaque psoriasis affects approximately 7.5 million Americans with potent topical corticosteroids prescribed to approximately 80% of psoriasis patients diagnosed. LEXETTE is part of the US$600m potent topical corticosteroid market for which 8 million prescriptions are written annually.
Mayne Pharma's CEO, Scott Richards, said: "LEXETTE is an elegant foam formulation that will give psoriasis patents more treatment options. The foam delivery platform has a well-established reputation with dermatologists due to ease of application and lack of greasiness and stickiness, especially in hair-bearing areas and under clothing. LEXETTE will be supported by our existing psoriasis-focused sales team who will now be able to offer a potent steroid along with steroid-free SORILUX® Foam, which are both commonly used in psoriasis treatment protocols."
Mayne Pharma directly markets more than 60 products in the US including four branded dermatology products FABIOR® (tazarotene) Foam, SORILUX (calcipotriene) Foam, DORYX® MPC (doxycycline hyclate) delayed-release tablets and LEXETTE (halobetasol propionate) Foam. The Company recently received approval for TOLSURA™ (SUBA®-itraconazole) capsules used to treat certain fungal infections which it also recently launched.