TADALISTA WAS TAKEN ONCE DAILY AT DOSES RANGING FROM 2.5 TO 10 MG. FOOD AND ALCOHOL INTAKE WERE NOT RESTRICTED.

July 20, 2018

Patients were encouraged to make 4 separate attempts at their assigned dose and assigned timepoint. In the first of these studies, 348 patients with ED were randomized to placebo or TADALISTA 20 mg. Patients were encouraged to make 4 total attempts at intercourse; 2 attempts were to occur at 24 hours after dosing and 2 completely separate attempts were to occur at 36 hours after dosing. Two studies were conducted to assess the efficacy of TADALISTA at a given timepoint after dosing, specifically at 24 hours and at 36 hours after dosing.

TADALISTA was shown to be effective in treating patients who developed ED following bilateral nerve-sparing radical prostatectomy In 1 randomized, placebo-controlled, double-blinded, parallel-arm design prospective trial in this population (N=303), TADALISTA demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary (see Table 16). Therefore, in all 7 primary efficacy and safety studies, TADALISTA showed statistically significant improvement in patients’ ability to achieve an erection sufficient for vaginal penetration and to maintain the erection long enough for successful intercourse, as measured by the IIEF questionnaire and by SEP diaries. In addition, there were improvements in EF domain scores, success rates based upon SEP Questions 2 and 3, and patient-reported improvement in erections across patients with ED of all degrees of disease severity while taking TADALISTA, compared to patients on placebo.

The treatment effect of TADALISTA did not diminish over time. In these 7 trials, TADALISTA was taken as needed, at doses ranging from 2.5 to 20 mg, up to once per day. In mice and rats, lymphoid necrosis and hemorrhage were seen in the spleen , thymus , and mesenteric lymph nodes at unbound Tadalista exposure of 2- to 33-fold above the human exposure (AUCs) at the MRHD of 20 mg. In dogs, an increased incidence of disseminated arteritis was observed in 1- and 6-month studies at unbound Tadalista exposure of 1- to 54-fold above the human exposure (AUC) at the MRHD of 20 mg. In a 12-month dog study, no disseminated arteritis was observed, but 2 dogs exhibited marked decreases in white blood cells (neutrophils) and moderate decreases in platelets with inflammatory signs at unbound Tadalista exposures of approximately 14- to 18-fold the human exposure at the MRHD of 20 mg. The abnormal blood-cell findings were reversible within 2 weeks after stopping treatment.

In patients with BPH following single and multiple-doses of 20 mg Tadalista, no statistically significant differences in exposure (AUC and Cmax) were observed between elderly (70 to 85 years) and younger (.60 years of age) subjects. In male patients with diabetes mellitus after a 10 mg Tadalista dose, exposure (AUC) was reduced approximately 19% and Cmax was 5% lower than that observed in healthy subjects. Figure 4: Plasma Tadalista concentrations (mean ± SD) following a single 20-mg Tadalista dose and single and once daily multiple doses of 5 mg.

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