Transmucosal administration of phosphodiesterase inhibitors for the treatment of erectile dysfunction
AssigneeVivus, Inc.
InventorsPaul C. Doherty, Jr., Virgil A. Place, William L. Smith
Life of this patent
Estimating the term…
Abstract
A method is provided for treating erectile dysfunction in a mammalian male individual. The method involves the transmucosal administration of a phosphodiesterase inhibitor or a pharmaceutically acceptable salt, ester, amide or derivative thereof, within the context of an effective dosing regimen. Preferred modes of administration include transbuccal, sublingual and transrectal routes. Pharmaceutical formulations and kits are provided as well.
Claims51
A method for treating erectile dysfunction in a male individual, comprising transmucosally administering to the individual an effective amount of a phosphodiesterase inhibitor or a pharmaceutically acceptable salt, ester, amide or prodrug thereof, wherein the phosphodiesterase inhibitor is selected from the group consisting of Type III phosphodiesterase inhibitors, Type IV phosphodiesterase inhibitors, and combinations thereof.
A method for treating erectile dysfunction in a male individual, comprising sublingually administering to the individual a sublingual dosage form that completely disintegrates within approximately 10 seconds to 30 minutes after administration and is selected from the group consisting of a sublingual tablet, cream, ointment or paste, said sublingual dosage form containing a therapeutically effective unit dose of an active agent selected from Type V phosphodiesterase inhibitors and pharmaceutically acceptable salts, esters, amides and prodrugs thereof, and a pharmaceutically acceptable carrier.
A method for treating erectile dysfunction in a male individual, comprising applying to the buccal mucosa of the individual a bioerodible buccal dosage unit that adheres to the buccal mucosa and erodes thereon over a period of approximately 0.5 to 24 hours, said dosage unit containing (a) a therapeutically effective unit dose of an active agent selected from Type V phosphodiesterase inhibitors and pharmaceutically acceptable salts, esters, amides and prodrugs thereof, and (b) a hydrolyzable polymeric carrier, wherein the active agent represents approximately 1 wt.% to 60 wt.% of the buccal dosage unit.
A method for treating erectile dysfunction in a male individual, comprising transrectally administering to the individual a transrectal dosage form that completely disintegrates within approximately 10 minutes to 6 hours following administration and is selected from the group consisting of a rectal suppository, cream, ointment, and enema solution, said transrectal dosage form containing a therapeutically effective amount unit dose of an active agent selected from Type V phosphodiesterase inhibitors and pharmaceutically acceptable salts, esters, amides and prodrugs thereof, and a pharmaceutically acceptable carrier.
Dependencies are inferred from the claim text.