Tadalafil (Page 10 of 12)

14.4 Tadalafil Tablets 5 mg for Once Daily Use for ED and BPH

The efficacy and safety of tadalafil for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either tadalafil 2.5 mg, 5 mg, for once daily use or placebo. ED severity ranged from mild to severe and BPH severity ranged from moderate to severe. The full study population had a mean age of 63 years (range 45 to 83) and was 93% White, 4% Black, 3% other races; 16% were of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.

In this study, the co-primary endpoints were total IPSS and the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). One of the key secondary endpoints in this study was Question 3 of the Sexual Encounter Profile diary (SEP3). Timing of sexual activity was not restricted relative to when patients took tadalafil.

The efficacy results for patients with both ED and BPH, who received either tadalafil 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8.

Tadalafil 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. Tadalafil 5 mg for once daily use also resulted in statistically significant improvement in SEP3. Tadalafil 2.5 mg did not result in statistically significant improvement in the total IPSS.

Table 21: Mean IPSS and IIEF EF Domain Changes in the Tadalafil 5 mg for Once Daily Use Study in Patients with ED and BPH

	P lacebo	Tadalafil 5 mg	p-value
T ot al Symptom Score (IPSS)
	( N=193)	( N=206)
Baseline	18.2	18.5
Change from Baseline to Week 12	-3.8	-6.1	<.001
E F Domain Score (IIEF EF)
	( N=188)	( N=202)
Baseline	15.6	16.5
Endpoint	17.6	22.9
Change from Baseline to Week 12	1.9	6.5	<.001

T able 22: Mean SEP Question 3 Changes in the Tadalafil 5 mg for Once Daily Use Study in Patients with ED and BPH

	P lacebo	Tadalafil 5 mg
	( N=187)	( N=199)	p-value
M aintenance of Erection (SEP3)
Baseline	36%	43%
Endpoint	48%	72%
Change from Baseline to Week 12	12%	32%	<.001

Tadalafil for once daily use resulted in improvement in the IPSS total score at the first scheduled observation (week 2) and throughout the 12 weeks of treatment (see Figure 8).

F igure 8: Mean IPSS Changes in ED/BPH Patients by Visit in Study L

In this study, the effect of tadalafil 5 mg once daily on Q_max was evaluated as a safety endpoint. Mean Q_max increased from baseline in both the treatment and placebo groups (tadalafil 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Tadalafil Tablets USP, 2.5 mg are supplied as white to off-white, round, biconvex, film-coated tablets debossed with “C1” on one side and plain on the other.

They are available as follows:

Bottles of 30: NDC 69238-1346-3

Tadalafil Tablets USP, 5 mg are supplied as yellow colored, round, biconvex, film-coated tablets debossed with “A13” on one side and plain on the other.

They are available as follows:

Bottles of 30: NDC 69238-1347-3

Tadalafil Tablets USP, 10 mg are supplied as yellow colored, round, biconvex, film-coated tablets debossed with “AC” above “06” on one side and plain on the other.

They are available as follows:

Bottles of 30: NDC 69238-1348-3

Tadalafil Tablets USP, 20 mg are supplied as yellow colored, oval, biconvex, film-coated tablets debossed with “AA” on one side and “09” on the other.

They are available as follows:

Bottles of 30: NDC 69238-1349-3

16.2 Storage

Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Keep this and all medications out of reach of children.