2017 ACVIM Forum Research Abstract Program

Mirtazapine 2% transdermal ointment was well tolerated in cats when administered at 5 mg/kg for 28 consecutive days. This study was a multi-center, double-blind, placebo-controlled, randomized study. Cats at least 1 year of age, weighing ≥ 2 kg, with a documented medical history of ≥ 5% body weight loss that was deemed clinically significant were enrolled. Cats could not have a serum creatinine > 5.0 mg/dL or diagnosed neoplasia. Randomization was 1:1 (mirtazapine:placebo). 2% MZP was dosed at 2 mg per cat (equivalent to 0.1 mL volume of ointment) regardless of body weight. The placebo ointment was identical to treatment ointment but without active ingredient mirtazapine, and was dosed at the same volume. The ointments were administered to the inner pinna daily for 14 AE 3 days. Effectiveness was demonstrated by comparison of mean percent change in body weight between the Day 1 and Week 2 visits using a two-sample t-test with significance set at P < 0.05 where the percent change in body weight in the 2% MZP group was greater than or equal to 0. Clinical pathology data from all cases receiving the 2% MZP or placebo were included in the safety analysis and each variable was analyzed using Analysis of Covariance, with treatment as a fixed effect and the baseline value as a covariate. Adverse events for safety analysis included any observations, whether or not considered to be product related, that were unfavorable and unintended, and that occurred after the use of study drug on Day 1 through study termination.