HP-03-004 Establishing the safety profile in sexual partners of a new topical glyceryl trinitrate gel for the treatment of erectile dysfunction

Abstract

MED2005 is a fast-acting, topical, glyceryl trinitrate (GTN) gel for the treatment of erectile dysfunction (ED), applied directly to the glans penis by the male or his partner.1 As there is potential for transfer to the female partner, the safety of MED2005 in sexual partners was investigated. (A) In a 232 ED patient Phase IIA study, adverse events (AEs) were recorded in female partners following the application of 0.2% MED2005 (n=229) to the penis before intercourse.1 (B) A pharmacokinetic study measured GTN absorption by tandem mass spectrometry on penile swabs taken 5 minutes after administration of 0.8% MED2005 to the glans penis (n=10). (C) Disruption to the epidermal membrane 2 hours after administration of MED2005 was measured by impedance testing on cadaveric human epidermal tissue and significance compared to commercial lubricants using the Wilcoxon signed rank test. (A) In over 1003 intercourse events, only 4 mild AEs in females were related to their partners’ MED2005 treatment; two cases of headache and one case each of vulvovaginal pruritis and nasopharyngitis. (B) Five minutes after application, an average of 27% of MED2005 remained on the penis, indicating absorption of 73% of the gel. Linear input rates predicted that virtually no MED2005 would remain on the penis 10 minutes after application. (C) Impedance testing showed no significant difference between MED2005 and commercial lubricants on integrity of human epidermal membranes, p=0.58 and 0.30 compared to KY warming and Astroglide, respectively.