Treatment of Comorbid Premature Ejaculation and Erectile Dysfunction
The invention provides a method of treating comorbid premature ejaculation and erectile dysfunction. In particular, the method comprises administering an effective amount of a tramadol material and an effective amount of a phosphodiesterase inhibitor. The invention also provides a pharmaceutical composition comprising a pharmaceutically-acceptable carrier, a tramadol material and a phosphodiesterase inhibitor. The invention further provides a kit comprising a tramadol material and a phosphodiesterase inhibitor.
1 . A method of treating comorbid premature ejaculation and erectile dysfunction in a human male comprising administering an effective amount of a tramadol material and an effective amount of a phosphodiesterase (PDE) inhibitor to the male an effective time prior to sexual activity.
2 . The method of claim 1 wherein the tramadol material is tramadol or a pharmaceutically-acceptable form thereof, and the PDE inhibitor is a PDE3, PDE4 or PDE5 inhibitor.
3 . The method of claim 2 wherein the PDE inhibitor is a PDE5 inhibitor.
4 . The method of claim 3 wherein the tramadol material is (±)cis-tramadol or a pharmaceutically-acceptable salt thereof, and the PDE5 inhibitor is sildenafil or a pharmaceutically-acceptable form thereof, vardenafil or a pharmaceutically-acceptable form thereof, tadalafil or a pharmaceutically-acceptable form thereof, or a combination of two or more of the foregoing PDE5 inhibitors.
5 . The method of claim 4 wherein the tramadol material is (±)cis-tramadol hydrochloride, and the PDE5 inhibitor is sildenafil citrate, vardenafil hydrochloride, tadalafil or a combination of two or more of the foregoing PDE5 inhibitors.
6 . The method of claim 5 wherein the PDE5 inhibitor is sildenafil citrate.
7 . A pharmaceutical composition comprising a pharmaceutically-acceptable carrier, a tramadol material and a phosphodiesterase (PDE) inhibitor.
8 . The composition of claim 7 wherein the tramadol material is tramadol or a pharmaceutically-acceptable form thereof, and the PDE inhibitor is a PDE3, PDE4 or PDE5 inhibitor.
9 . The composition of claim 8 wherein the PDE inhibitor is a PDE5 inhibitor.
10 . The composition of claim 9 wherein the tramadol material is (±)cis-tramadol or a pharmaceutically-acceptable salt thereof, and the PDE5 inhibitor is sildenafil or a pharmaceutically-acceptable form thereof, vardenafil or a pharmaceutically-acceptable form thereof, tadalafil or a pharmaceutically-acceptable form thereof, or a combination of two or more of the foregoing PDE5 inhibitors.
11 . The composition of claim 10 wherein the tramadol material is (±)cis-tramadol hydrochloride, and the PDE5 inhibitor is sildenafil citrate, vardenafil hydrochloride, tadalafil or a combination of two or more of the foregoing PDE5 inhibitors.
12 . The composition of claim 11 wherein the PDE5 inhibitor is sildenafil citrate.
13 . A kit comprising:
(a) a container holding a tramadol material and a phosphodiesterase (PDE) inhibitor; or
(b) a first container holding a tramadol material and a second container holding a phosphodiesterase (PDE) inhibitor.
14 . The kit of claim 13 wherein the tramadol material is tramadol or a pharmaceutically-acceptable form thereof, and the PDE inhibitor is a PDE3, PDE4 or PDE5 inhibitor.
15 . The kit of claim 14 wherein the PDE inhibitor is a PDE5 inhibitor.
16 . The kit of claim 15 wherein the tramadol material is (±)cis-tramadol or a pharmaceutically-acceptable salt thereof, and the PDE5 inhibitor is sildenafil or a pharmaceutically-acceptable form thereof, vardenafil or a pharmaceutically-acceptable form thereof, tadalafil or a pharmaceutically-acceptable form thereof, or a combination of two or more of the foregoing PDE5 inhibitors.
17 . The kit of claim 16 wherein the tramadol material is (±)cis-tramadol hydrochloride, and the PDE5 inhibitor is sildenafil citrate, vardenafil hydrochloride, tadalafil or a combination of two or more of the foregoing PDE5 inhibitors.
18 . The kit of claim 17 wherein the PDE5 inhibitor is sildenafil citrate.
19 . The kit of claim 13 further comprising instructions for using the tramadol material and the PDE inhibitor to treat comorbid premature ejaculation and erectile dysfunction in a male.