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PHARMACOKINETICS

Pharmacokinetics of Dapoxetine, a New Treatment for Premature Ejaculation: Impact of Age and Effects of a High-Fat Meal

Mark J. Dresser, PhD, Dongwoo Kang, PhD, Peter Staehr, MD, Shalini Gidwani, MS, Cindy Guo, MS, John P. Mulhall, MD and Nishit B. Modi, PhD

From ALZA Corporation, Mountain View, California (Dr Dresser, Dr Kang, Dr Staehr, Ms Gidwani, Ms Guo, Dr Modi), and the Department of Urology, Weill Medical College of Cornell University, New York–Presbyterian Hospital, New York, New York (Dr Mulhall).

Dapoxetine is being developed as a treatment for premature ejaculation and has demonstrated rapid absorption and elimination in previous pharmacokinetic studies. Two open-label studies were conducted in healthy men: a parallel-group pharmacokinetic and safety study in young and elderly men and a randomized crossover food-effect study. Maximal plasma dapoxetine concentrations (Cmax) were similar in young and elderly men (338 and 310 ng/mL, respectively), as were the corresponding area under the plasma concentration versus time curve (AUC) values (2040 and 2280 ng·h/mL, respectively). When coadministered with food, Cmax was reduced by 11% (398 vs 443 ng/mL in the fed and fasted states, respectively), and the peak was delayed by approximately 30 minutes, indicating that food slowed the rate of absorption; however, systemic exposure to dapoxetine (ie, AUC) was not affected by food consumption. Thus, age or consumption of a high-fat meal has only a modest impact on dapoxetine pharmacokinetics in healthy men.

Key Words: Dapoxetine • pharmacokinetics • food • age • premature ejaculation

Address for reprints: Mark J. Dresser, PhD, ALZA Corporation, 1900 Charleston Road, Building M11-4, Mountain View, CA 94043; e-mail: mdresser{at}alzus.jnj.com.






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