Methods for treating erectile dysfunction with a cgmp-specific phosphodiesterase 5 inhibitor pharmaceutical composition

Abstract

A method is provided for treating erectile dysfunction in a subject in need thereof by administering a cGMP-specific phosphodiesterase 5 (PDE 5 ) inhibitor pharmaceutical composition to a subject qualified for over-the-counter access to the PDE 5 inhibitor pharmaceutical composition. In some embodiments, the PDE 5 inhibitor pharmaceutical composition includes tadalafil or vardenafil.

1 - 20 . (canceled) 
     
     
         21 . A method for treating erectile dysfunction in a subject, the method comprising:
 a) receiving a request for a cGMP-specific phosphodiesterase 5 (PDE5) inhibitor pharmaceutical composition;   b) obtaining information, about the subject, the information comprising:
 a gender of the subject, 
 an age of the subject, 
 an erectile dysfunction status of the subject, 
 whether the subject is taking a vasodilator composition comprising a nitrate or a nitrite, 
 whether the subject is taking a guanylate cyclase stimulator medication, 
 whether the subject is taking a PDE5 inhibitor pharmaceutical composition, 
 whether the subject has ever had a heart problem, 
 a blood pressure status of the subject, 
 whether the subject has ever had a stroke, 
 whether the subject has a liver problem, 
 a kidney function status of the subject, 
 whether the subject has retinitis pigmentosa, 
 whether the subject has experienced vision loss, 
 whether the subject has ever had a stomach ulcer, 
 whether the subject has a bleeding disorder, 
 a genital status of the subject, 
 whether the subject has ever experienced priapism, 
 whether the subject has a blood cell disorder, and 
 whether the subject is taking a medication that interacts with the PDE5 inhibitor pharmaceutical composition. 
   c) comparing all or a portion of the information about the subject against a plurality of filters, wherein, when a respective filter in the plurality of filters is fired by the comparing, the method is terminated or the subject is provided with a warning corresponding to the respective filter, and wherein the plurality of filters comprises:
 a gender filter that is fired when the information indicates that the subject is female, 
 an age filter, 
 an erectile dysfunction filter that is fired at least when the information indicates that the subject does not have erectile dysfunction, 
 a vasodilator filter that is fired at least when the information indicates that the subject is taking a vasodilator composition comprising a nitrate or a nitrite, 
 a PDE5 inhibitor filter that is fired at least when the information indicates that the subject is taking a PDE5 inhibitor pharmaceutical composition, 
 a guanylate cyclase stimulator filter that is fired at least when the information indicates that the subject is taking a guanylate cyclase stimulator mediation, 
 a heart problem filter that is fired at least when the information indicates that the subject has had a heart problem, 
 a blood pressure filter that this fired at least when the information indicates that the subject has either (i) low blood pressure, or (ii) uncontrolled high blood pressure, 
 a stroke filter that is fired at least when the information indicates that the subject has had a stroke, 
 a liver disease filter that is fired at least when the information indicates that the subject has a liver problem, 
 a kidney disease filter that is fired at least when the information indicates that the subject has a kidney problem, 
 a retinitis pigmentosa filter that is fired at least when the information indicates that the subject has retinitis pigmentosa, 
 a vision deterioration filter that is fired at least when the information indicates that the subject has had severe vision loss, 
 a stomach ulcer filter that is fired at least when the information indicates that the subject has had a stomach ulcer, 
 a bleeding problem filter that is fired at least when the information indicates that the subject has a bleeding disorder, 
 a genital abnormality filter that is fired at least when the information indicates that the subject has an abnormal penile shape, 
 a priapism filter that is fired at least when the information indicates that the subject has experienced priapism, 
 a blood cell disorder filter that is fired at least when the information indicates that the subject has a blood cell disorder selected from the group consisting of sickle cell anemia, multiple myeloma, and leukemia, and 
 a drug interaction filter that is fired at least when the information indicates that the subject is taking a medication that interacts with the PDE5 inhibitor pharmaceutical composition; and 
   d) proceeding with the method, when the method is not already terminated by the comparing, by authorizing a provision of the PDE5 inhibitor pharmaceutical composition to the subject; and   e) administering the PDE5 inhibitor pharmaceutical composition to the subject, after provision of the PDE5 inhibitor pharmaceutical composition has been authorized for the subject.   
     
     
         22 . The method of  claim 21 , the method further comprising receiving from the subject an acknowledgement of each warning associated with each filter that was fired in the comparing c) that did not terminate the method. 
     
     
         23 . The method of  claim 21 , the method further comprising communicating an over-the-counter facts label for the PDE5 inhibitor pharmaceutical composition to the subject before the authorization of the provision. 
     
     
         24 . The method of  claim 23 , the method further comprising receiving a confirmation from the subject that the subject has received and read the over-the-counter facts label for the PDE5 inhibitor pharmaceutical composition before the authorization of the provision. 
     
     
         25 . The method of  claim 21 , wherein the PDE5 inhibitor pharmaceutical composition has the structure: 
       
         
           
           
               
               
           
         
         wherein:
 R 0  represents hydrogen, halogen or C 1-6  alkyl; 
 R 1  represents hydrogen, C 1-6  alkyl, C 2-6  alkenyl, C 2-6  alkynyl, haloC 1-6  alkyl, C 3-8  cycloalkyl, C 3-8  cycloalkyl-C 1-3  alkyl, arylC 1-3  alkyl or heteroarylC 1-3  alkyl; 
 R 2  represents an optionally substituted mono-cyclic aromatic ring selected from benzene, thiophene, furan and pyridine or an optionally substituted bicyclic ring 
 
       
       
         
           
           
               
               
           
         
         
            attached to the rest of the molecule via one of the benzene ring carbon atoms and wherein the fused ring A is a 5- or 6-membered ring which may be saturated or partially or fully unsaturated and comprises carbon atoms and optionally one or two heteroatoms selected from oxygen, sulphur and nitrogen; and 
           R 3  represents hydrogen or C1-3 alkyl, or R 1  and R 3  together represent a 3- or 4-membered alkyl or alkenyl chain, 
         
         or a pharmaceutically acceptable salt thereof. 
       
     
     
         26 . The method of  claim 21 , wherein the PDE5 inhibitor pharmaceutical composition is tadalafil or a pharmaceutically acceptable salt thereof. 
     
     
         27 . The method of  claim 23 , the method further comprising receiving a confirmation from the subject that the over-the-counter drug facts label has been received and read, and wherein the subject is authorized for provision of a dosage of from 2.5 mg to 10 mg of tadalafil no more than once per day. 
     
     
         28 . The method of  claim 23 , the method further comprising receiving a confirmation from the subject that the over-the-counter drug facts label has been received and read, and wherein the subject is authorized for provision of a dosage of 5 mg of tadalafil no more than once per day. 
     
     
         29 . The method of  claim 21 , wherein the PDE5 inhibitor pharmaceutical composition is vardenafil. 
     
     
         30 . The method of  claim 21 , wherein the age filter is fired when the information from the subject indicates that the subject is less than eighteen years old. 
     
     
         31 . The method of  claim 21 , wherein the vasodilator composition, which is capable of firing the vasodilator filter, includes a compound selected from the group consisting of nitroglycerin, amyl nitrate, amyl nitrite, and butyl nitrate. 
     
     
         32 . The method of  claim 21 , wherein the drug interaction filter is fired when the first plurality of survey results indicates that the subject is taking a medication selected from the group consisting of an alpha blocker, an HIV protease inhibitor, an antifungal medication, an antibiotic, a blood pressure medication, and an erectile dysfunction medication. 
     
     
         33 . The method of  claim 21 , wherein the heart problem, which is capable of firing the heart problem filter, is selected from the group consisting of a heart attack, arrhythmia, angina, chest pain, narrowing of the aortic valve, and heart failure. 
     
     
         34 . The method of  claim 21 , wherein:
 the warning corresponding to a respective filter in the plurality of filters that does not terminate the method comprises a prompt for the subject to indicate whether they have discussed the risk factor underlying the respective filter in the plurality of filters that was fired with a health care provider; and   acknowledgement is obtained from the subject when the subject indicates that they have discussed the risk factor underlying the respective filter in the plurality of filters that was fired with a health care provider.   
     
     
         35 . The method of  claim 21 , further comprising storing a destination associated with the subject in a subject profile upon authorizing the provision. 
     
     
         36 . The method of  claim 21 , further comprising coordinating shipping of the PDE5 inhibitor pharmaceutical composition to a physical address associated with the subject upon authorizing the provision. 
     
     
         37 . A method for treating erectile dysfunction in a subject, the method comprising:
 a) receiving a re-order request for a cGMP-specific phosphodiesterase 5 (PDE5) inhibitor pharmaceutical composition;   b) obtaining information about the subject, the information comprising:
 an erectile dysfunction status of the subject, 
 whether the subject has started to take a vasodilator composition comprising a nitrate or a nitrite since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 whether the subject has started to take a guanylate cyclase stimulator medication since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 whether the subject has started to take a PDE5 inhibitor pharmaceutical composition since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 whether the subject has experienced a symptom of heart problems during sexual intercourse since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 whether the subject has experienced priapism since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 whether the subject has experienced hearing or vision loss since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 whether the subject has developed a symptom of heart problems since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 a blood pressure status of the subject, 
 whether the subject has had a stroke since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 whether the subject has developed a liver problem since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 a kidney function status of the subject, 
 whether the subject has developed retinitis pigmentosa since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 whether the subject has developed a stomach ulcer since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 whether the subject has developed a bleeding disorder since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 whether the subject has developed an abnormal genital shape since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 whether the subject has developed a blood cell disorder since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, and 
 whether the subject has started taking a medication that interacts with the PDE5 inhibitor pharmaceutical composition since receiving their last provision of the PDE5 inhibitor pharmaceutical composition; 
   c) comparing all or a portion of the information about the subject against a plurality of re-assessment filters, wherein, when a respective re-assessment filter in the plurality of re-assessment filters is fired by the comparing, the method is terminated or the subject is provided with a warning corresponding to the respective re-assessment filter, and wherein the plurality of filters comprises:
 an erectile dysfunction re-assessment filter that is fired at least when the information indicates that the subject does not have erectile dysfunction, 
 a vasodilator re-assessment filter that is fired at least when the information indicates that the subject is taking a vasodilator composition comprising a nitrate or a nitrite, 
 a guanylate cyclase stimulator re-assessment filter that is fired at least when the information indicates that the subject is taking a guanylate cyclase stimulator mediation, 
 a PDE5 inhibitor re-assessment filter that is fired at least when the information indicates the subject is taking a PDE5 inhibitor pharmaceutical composition; 
 a sexual intercourse re-assessment filter that is fired at least when the information indicates that the subject has experienced a symptom of heart problems during sexual intercourse since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 a priapism re-assessment filter that is fired at least when the information indicates that the subject has had priapism since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, and 
 a sensory deterioration re-assessment filter that is fired at least when the information indicates that the subject has experienced a sudden vision loss or sudden hearing loss since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 a heart problem re-assessment filter that is fired at least when the information indicates that the subject has developed a heart problem since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 a blood pressure re-assessment filter that this fired at least when the information indicates that the subject has developed either (i) low blood pressure, or (ii) uncontrolled high blood pressure, 
 a stroke re-assessment filter that is fired at least when the information indicates that the subject has had a stroke since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 a liver disease re-assessment filter that is fired at least when the information indicates that the subject has developed liver disease since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 a kidney disease re-assessment filter that is fired at least when the information indicates that the subject has developed a kidney problem since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 a retinitis pigmentosa re-assessment filter that is fired at least when the information indicates that the subject has been diagnosed with retinitis pigmentosa since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 a stomach ulcer re-assessment filter that is fired at least when the information indicates that the subject has developed a stomach ulcer since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 a bleeding problem re-assessment filter that is fired at least when the information indicates that the subject has developed a bleeding disorder since receiving their last provision of PDE5 inhibitor pharmaceutical composition, 
 a genital abnormality re-assessment filter that is fired at least when the information indicates that the subject has developed an abnormal genital shape since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, 
 a blood cell disorder re-assessment filter that is fired at least when the information indicates that the subject has developed a blood disorder selected from the group consisting of sickle cell anemia, multiple myeloma, and leukemia, since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, and 
 a drug interaction re-assessment filter that is fired at least when the information indicates that the subject has started taking a medication that interacts with the PDE5 inhibitor pharmaceutical composition since receiving their last provision of the PDE5 inhibitor pharmaceutical composition; 
   d) proceeding with the method when the method is not already terminated by comparing c), by authorizing a re-order provision of the PDE5 inhibitor pharmaceutical composition to the subject; and   (e) administering the PDE5 inhibitor pharmaceutical composition to the subject, following authorization of the re-order provision, to treat erectile dysfunction in the subject.   
     
     
         38 . The method of  claim 37 , the method further comprising receiving from the subject an acknowledgement of each warning associated with each filter that was fired in the comparing c) that does not terminate the method. 
     
     
         39 . The method of  claim 37 , the method further comprising communication an over-the-counter facts label for the PDE5 inhibitor pharmaceutical composition to the subject before the authorization of the re-order provision. 
     
     
         40 . The method of  claim 39 , the method further comprising receiving a confirmation from the subject that the subject has received and read the over-the-counter facts label for the PDE5 inhibitor pharmaceutical composition before the authorization of the re-order provision. 
     
     
         41 . The method of  claim 37 , wherein:
 the information further comprises whether the subject has experienced a side effect associated with the PDE5 inhibitor pharmaceutical composition since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, and   the plurality of re-assessment filters further comprises a side effect re-assessment filter that is fired at least when the information indicates that the subject has experienced, since receiving their last provision of the PDE5 inhibitor pharmaceutical composition, a side effect selected from the group consisting of headaches, abnormal vision, muscle pain, nausea, dizziness, and a skin rash.   
     
     
         42 . The method of  claim 41 , wherein the re-fulfillment method further comprises, when a respective re-assessment filter in the plurality of re-assessment filters is fired, storing a record associated with the firing of the respective re-assessment filter in an adverse event profile comprising records of re-assessment filter firing events associated with a plurality of subjects. 
     
     
         43 . The method of  claim 21 , wherein at least one filter in the plurality of filters terminates the method when fired and at least one filter in the plurality of filters issues a warning when filed. 
     
     
         44 . The method of  claim 37 , wherein at least one re-assessment filter in the plurality of re-assessment filters terminates the method when fired and at least one re-assessment filter in the plurality of re-assessment filters issues a warning when filed.