Method to treat premature ejaculation in humans
The present invention belongs to the fields of pharmacology, medicine and medicinal chemistry, and provides methods and compositions for treating sexual dysfunction; more particularly, the invention relates to treatment of premature ejaculation in humans.
1. A method of effectively treating premature ejaculation in a patient, comprising administering to the patient in need of such treatment an amount of agents comprising a) dextromethorphan or a pharmaceutically acceptable salt thereof, b) tramadol or a pharmaceutically acceptable salt thereof, and c) sildenafil or a pharmaceutically acceptable salt thereof, whereby the combined amount of said agents is effective to treat the premature ejaculation in the patient.
2. The method of claim 1 , wherein the agents are administered separately.
3. The method of claim 1 , wherein the agents are administered in combination.
4. The method of claim 1 , wherein the agents are administered prior to sexual activity.
5. The method of claim 1 , wherein the agents are administered orally, by means of an implant, parenterally, sub-dermally, sublingually, rectally, topically, or via inhalation.
6. The method of claim 5 , wherein the agents are administered orally.
7. The method of claim 1 wherein the agents are administered in a dosage form selected from the group consisting of a tablet, a multiparticulate formulation for oral administration; a solution, a sustained release formulation, a suspension or elixir for oral administration, an injectable formulation, an implantable device, a topical preparation, a transdermal delivery device, a suppository, a buccal tablet, and an inhalation formulation.
8. The method of claim 7 , wherein the dosage form is further defined as a solid oral dosage form formulated as a tablet or capsule.
9. The method of claim 1 , wherein the ratio of dextromethorphan to tramadol is from about 15:1 to 1:15.
10. The method of claim 9 , wherein the ratio of dextromethorphan to tramadol is from about 10:1 to 1:10.
11. The method of claim 10 , wherein the ratio of dextromethorphan to tramadol is from about 5:1 to 1:5.
12. The method of claim 11 , wherein the ratio of dextromethorphan to tramadol is about 1:2.
13. The method of claim 1 , wherein caffeine is included as an agent.
14. A pharmaceutical composition comprising a therapeutically effective amount of a combination of agents, the combination comprising a) dextromethorphan or a pharmaceutically acceptable salt thereof, b) tramadol or a pharmaceutically acceptable salt thereof, and c) sildenafil or a pharmaceutically acceptable salt thereof.
15. The pharmaceutical composition of claim 14 , wherein the pharmaceutical composition further comprises caffeine.