Eflornithine Cream Vaniqa™1: An Rx Topical Product for Unwanted Hair Growth

Several factors contributed to the successful development of an eflornithine preparation VaniqaTM (Rx product) that received the US regulatory approval in July 2000. These included: 1. a clearly defined mechanism of action of eflornithine for reduction of hair growth; 2. a favorable systemic and dermal safety profile in doses that can illicit a pharma­cological response; 3. a long-term use clinical safety data in humans from the chemopre – vention studies; 4. a favorable dermal safety from Phase-I and Phase-II clinical trials and a dose dependant facial hair growth reduction demonstrated in a double blinded, random­ized, placebo control studies; 5. a poor safety and/or efficacy profile of other available modalities such as hormonal treatments; and 6. a large unmet consumer need. Vaniqa con­tains 13.9% of eflornithine monohydrochloride in a moisturizing lotion base for topical application [57]. Studies reporting 15% eflornithine use, in fact, has 15% of eflornithine. monohydrochloride. monohydrate or 11.5% eflornithine in the cream vehicle containing 80.84% water, 4.24% glyceryl stearate, 4.09% PEG-100 stearate, 3.05% cetearyl alcohol, 2.5% ceteareth-20, 2.22% mineral oil, 1.67% steryl alcohol, 0.56% dimethicone, and 0.83% of paraben-based preservative cocktail.