justifying inserting it as an important risk in the RMP. Neither study (1889-1 The sponsor acknowledges the The sponsor’s or 1889-2) involved comment and would like to response is Australian patients. provide an update on the satisfactory. However, all findings are aforementioned studies. considered relevant and applicable to the local Phase IV clinical Study context. The sponsor should (TA-401) was completed in provide an update on January 2015. Its primary significant safety findings objective was to assess the effect from Studies1889-1 of daily treatment with avanafil and 1889-2 (TA-402). 100 mg on spermatogenesis over a period of 26 weeks. The secondary objective was to evaluate the safety and tolerability of daily use of avanafil in these subjects. A total of 181 subjects (healthy adult male subjects and male subjects with mild erectile dysfunction with normal sperm concentration) have been randomised in the study. This study has demonstrated that daily dosing with avanafil 100 mg for 26 weeks was generally well tolerated, and was not associated with any untoward effects on sperm concentration, count, motility, or morphology. Avanafil treatment was safe and well tolerated. The overall incidence of Treatment Emergent Adverse Events (TEAEs) was slightly higher in the placebo group (22.0%) than in the avanafil 100 mg group (15.6%). The incidence of study drug related TEAEs was higher in the avanafil 100 mg group (5.6%) than in the placebo group (2.2%). Most of the TEAEs were mild or moderate in severity. The most frequently reported TEAE for the placebo group and the avanafil 100 mg group was headache (3.3%). No subject died during this study. There was one SAE during this study, which occurred in the placebo group. The percentages of subjects who discontinued study drug due to an adverse event were low and similar for the two treatment groups. No clinically important
justifying inserting it as an important risk in the RMP. Neither study (1889-1 or 1889-2) involved Australian patients. However, all findings are considered relevant and applicable to the local context. The sponsor should provide an update on significant safety findings from Studies1889-1 and 1889-2 (TA-402). The sponsor acknowledges the comment and would like to provide an update on the aforementioned studies. Phase IV clinical Study (TA-401) was completed in January 2015. Its primary objective was to assess the effect of daily treatment with avanafil 100 mg on spermatogenesis over a period of 26 weeks. The secondary objective was to evaluate the safety and tolerability of daily use of avanafil in these subjects. A total of 181 subjects (healthy adult male subjects and male subjects with mild erectile dysfunction with normal sperm concentration) have been randomised in the study. This study has demonstrated that daily dosing with avanafil 100 mg for 26 weeks was generally well tolerated, and was not associated with any untoward effects on sperm concentration, count, motility, or morphology. Avanafil treatment was safe and well tolerated. The overall incidence of Treatment Emergent Adverse Events (TEAEs) was slightly higher in the placebo group (22.0%) than in the avanafil 100 mg group (15.6%). The incidence of study drug related TEAEs was higher in the avanafil 100 mg group (5.6%) than in the placebo group (2.2%). Most of the TEAEs were mild or moderate in severity. The most frequently reported TEAE for the placebo group and the avanafil 100 mg group was headache (3.3%). No subject died during this study. There was one SAE during this study, which occurred in the placebo group. The percentages of subjects who discontinued study drug due to an adverse event were low and similar for the two treatment groups. No clinically important The sponsor’s response is satisfactory.