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Vaniqa - Clinical Studies
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Patient Information Bristol-Myers Squibb Labeling Vaniqa - July 27, 2000 Vaniqa (eflornithine hydrochloride) Cream, 13.9% For topical dermatological use only. Not for ophthalmic, oral or intravaginal use. DESCRIPTION Vaniqa is a cream containing 13.9% (139 mg/g) of anhydrous eflornithine hydrochloride as eflornithine hydrochloride monohydrate (150 mg/g). Other ingredients include: ceteareth-20, cetearyl alcohol, dimethicone, glyceryl stearate, methylparaben, mineral oil, PEG-100 stearate, phenoxyethanol, propylparaben, stearyl alcohol and water.
CLINICAL PHARMACOLOGY Pharmacodynamics There are no studies examining the inhibition of the enzyme ornithine decarboxylase (ODC) in human skin following the application of topical eflornithine. However, there are studies in the literature that report the inhibition of ODC activity in skin following oral eflornithine. It is postulated that topical eflornithine hydrochloride irreversibly inhibits skin ODC activity. This enzyme is necessary in the synthesis of polyamines. Animal data indicate that inhibition of ornithine decarboxylase inhibits cell division and synthetic functions, which affect the rate of hair growth. Vaniqa has been shown to retard the rate of hair growth in non-clinical and clinical studies. Pharmacokinetics The mean percutaneous absorption of eflornithine in women with unwanted facial hair, from a 13.9% w/w cream formulation, is < 1% of the radioactive dose, following either single or multiple doses under conditions of clinical use, that included shaving within 2 hr before 1 radiolabeled dose application in addition to other forms of cutting or plucking and tweezing to remove facial hair. Steady state was reached within four days of twice-daily application. The apparent steady-state plasma t1/2 of eflornithine was approximately 8 hours. Following twice daily application of 0.5 g of the cream (total dose 1.0 g/day; 139 mg as anhydrous eflornithine hydrochloride), under conditions of clinical use in women with unwanted facial hair (n=10), the steady-state Cmax, Ctrough and AUC12hr were approximately 10 ng/mL, 5 ng/mL, and 92 ng hr/mL, respectively, expressed in terms of the anhydrous free base of eflornithine hydrochloride. At steady state, the dose-normalized peak concentrations (Cmax) and the extent of daily systemic exposure (AUC) of eflornithine following twice-daily application of 0.5 g of the cream (total dose 1.0 g/day) is estimated to be approximately 100- and 60-fold lower, respectively, when compared to 370 mg/day once-daily oral doses. This compound is not known to be metabolized and is primarily excreted unchanged in the urine. INDICATIONS AND USAGE Vaniqa is indicated for the reduction of unwanted facial hair in women. Vaniqa has only been studied on the face and adjacent involved areas under the chin of affected individuals. Usage should be limited to these areas of involvement. CLINICAL TRIALS Results of topical dermal studies for contact sensitization, photocontact sensitization, and photocontact irritation reveal that under conditions of clinical use, Vaniqa is not expected to cause contact sensitization, phototoxic, or photosensitization reactions. Results of the topical dermal study for contact irritation did reveal that Vaniqa could cause irritation reactions in clinical use in susceptible individuals or under conditions of exaggerated use. Two randomized double-blind studies involving 594 female patients (393 treated with Vaniqa, 201 with vehicle) treated twice daily for up to 24 weeks evaluated the efficacy of Vaniqa in the reduction of unwanted facial hair in women. Women in the trial had a customary frequency of removal of facial hair two or more times per week. Women with facial conditions such as severe inflammatory acne, women who were pregnant, and nursing mothers were excluded from the studies. Physicians assessed the improvement or worsening from the baseline condition (Physician’s Global Assessment [PGA]), 48 hours after shaving, of all treated areas. Statistically significant improvement for Vaniqa versus vehicle was seen in each of these studies for “marked improvement” or greater response (24-week time point; p£ 0.001). Marked improvement was seen consistently at 8 weeks after initiation of treatment and continued throughout the 24 weeks of treatment. Hair growth approached pretreatment levels within 8 weeks of treatment withdrawal. Clinical trials with Vaniqa involved over 1370 women with unwanted facial hair of skin types I-VI, of whom 68% were White, 17% Black, 11% Hispanic-Latino, 2% Asian-Pacific Islander, 0.6% American Native, and 1.3% other. Click
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