Method for administering a medicament suitable for treating a migraine or cluster headache

Abstract

A method for administering a medicament suitable for treating a migraine or cluster headache to a patient in need thereof includes placing a mounting surface of a fluid delivery apparatus with the medicament in contact with at least a portion of the skin of said patient. A flow rate of the medicament from the fluid delivery apparatus is adjusted such that the medicament is delivered to the patient for at least a predetermined time period. The fluid delivery apparatus includes a controller assembly having a body component defining an axis and a plunger component slidably coupled to the body component. The plunger is positionable between a first position in which the plunger is nearest to the body component and a second position in which the plunger component is furthest from the body component. A bias assembly is positioned between the body component and the plunger component. The bias assembly is configured to apply a two stage force profile to the plunger component. Also disclosed is method for administering a medicament to a patient in need thereof such that the Cmax, Tmax and AUC are within predetermined, therapeutically effective values. Such methods are effective in treating migraine and cluster headaches with sumatriptan or other medicament.

1 - 37 . (canceled) 
     
     
         38 . A method for administering a medicament suitable for treating a migraine or cluster headache to a patient in need thereof, said method comprising:
 placing a fluid delivery apparatus comprising said medicament in contact with at least a portion of the skin of said patient,   adjusting a flow rate of the medicament from the fluid delivery apparatus such that the medicament is delivered to the patient for at least a predetermined time period;   wherein said fluid delivery apparatus comprises a controller assembly comprising:   a body component defining an axis;   a plunger component slidably coupled to the body component, the plunger positionable between a first position in which the plunger is nearest to the body component, and a second position in which the plunger component is furthest from the body component; and   a biasing assembly positioned between the body component and the plunger component, the bias assembly configured to apply a two stage force profile, comprising a first profile and a second profile, wherein the first force profile is different than the second force profile, to the plunger component,   wherein the administering of the medicament to the patient provides a T max  of the medicament that is less than the T max  of the same medicament administered to a patient using at least one of an oral dosage formulation, a nasal dosage formulation, a transdermal dosage formulation or an inhaled dosage formulation of the same medicament.   
     
     
         39 . The method according to  claim 38 , wherein the predetermined time period is at least 60 minutes. 
     
     
         40 . The method in accordance with  claim 38 , wherein the flow rate in the fluid delivery apparatus is from 20 to 1000 μL/hr. 
     
     
         41 . The method in accordance with  claim 38 , wherein a plenum assembly of the fluid delivery apparatus comprises a plurality of microneedles. 
     
     
         42 . The method in accordance with  claim 38 , wherein the T max  is calibrated based on the first and second force profiles. 
     
     
         43 . The method in accordance with  claim 38 , wherein the T max  of the medicament is about 10% to about 80% less than the T max  of the same medicament administered to a patient using at least one of an oral dosage formulation, a nasal dosage formulation, a transdermal dosage formulation or an inhaled dosage formulation of the same medicament. 
     
     
         44 . The method in accordance with claim  1 , wherein the medicament is selected from the group consisting of aspirin, ibuprofen, acetaminophen, sumatriptan, rizatriptan, almotriptan, naratriptan, zolmitriptan, frovatriptan and eletriptan. 
     
     
         45 . The method in accordance with  claim 38 , wherein the delivery of the medicament to the patient provides a C max  of the medicament that is greater than a C max  of the same medicament delivered to a patient using at least one of an oral dosage formulation, a nasal dosage formulation, a transdermal dosage formulation or an inhaled dosage formulation. 
     
     
         46 . The method in accordance with  claim 38 , wherein the delivery of the medicament to the patient provides a C max  of the medicament in a range of from about 60 to 100 ng/mL. 
     
     
         47 . The method in accordance with  claim 38 , wherein the delivery of the medicament to the patient provides a T max  for the medicament of less than 30 minutes. 
     
     
         48 . The method in accordance with  claim 38 , wherein the delivery of the medicament to the patient provides an AUC ∞  for the medicament of greater than 9,000 ng·min/mL. 
     
     
         49 . The method in accordance with  claim 38 , wherein the delivery of the medicament to the patient provides an AUC ∞  of the medicament that is greater than the AUC ∞  of the same medicament delivered to a patient using at least one of an oral dosage formulation, a nasal dosage formulation, a subcutaneous dosage formulation, a transdermal dosage formulation or an inhaled dosage formulation. 
     
     
         50 . The method in accordance with  claim 38 , wherein the delivery of the medicament to the patient provides an AUC ∞  of the medicament that is greater than the AUC ∞  of the same medicament delivered to a patient using an oral dosage formulation, a nasal dosage formulation, a subcutaneous dosage formulation, a transdermal dosage formulation or an inhaled dosage formulation. 
     
     
         51 . A method for administering a medicament suitable for treating a migraine or cluster headache to a patient in need thereof, said method comprising:
 placing a fluid delivery apparatus comprising said medicament in contact with at least a portion of the skin of said patient,   adjusting a flow rate of the medicament from the fluid delivery apparatus such that the medicament is delivered to the patient for at least a predetermined time period;   wherein said fluid delivery apparatus comprises a controller assembly comprising:   a body component defining an axis;   a plunger component slidably coupled to the body component, the plunger positionable between a first position in which the plunger is nearest to the body component, and a second position in which the plunger component is furthest from the body component; and   a biasing assembly positioned between the body component and the plunger component, the bias assembly configured to apply a two stage force profile to the plunger component, the bias assembly comprising:   a first biasing member having a first force profile; and   a second biasing member having a second force profile, wherein the first force profile is different than the second force profile,   wherein the administering of the medicament to the patient provides a T max  of the medicament that is less than the T max  of the same medicament administered to a patient using at least one of an oral dosage formulation, a nasal dosage formulation, a transdermal dosage formulation or an inhaled dosage formulation of the same medicament, and   wherein the medicament is sumatriptan.   
     
     
         52 . The method according to  claim 51  wherein the delivery of sumatriptan to the patient provides an AUC ∞  that is at least double an AUC ∞  of sumatriptan delivered to the patient using a delivery method selected from the group consisting of a 100 mg oral tablet, a 20 mg nasal spray, a 6 mg subcutaneous injection, an iontophoretic administration using a 6.5 mg dose, and an 11 mg inhaled powder. 
     
     
         53 . The method according to  claim 51  wherein the delivery of sumatriptan to the patient provides a T max  less than half that compared to a T max  of sumatriptan delivered to the patient using a delivery method selected from the group consisting of a 100 mg oral tablet, a 20 mg nasal spray, an iontophoretic administration using a 6.5 mg dose, and an 11 mg inhaled powder. 
     
     
         54 . The method according to  claim 51  wherein a C ss  of sumatriptan delivered to a patient has a value that is at least double that compared to a C ss  value of sumatriptan delivered to the patient using a delivery method selected from the group consisting of a 20 mg nasal spray, a 6 mg subcutaneous injection, an iontophoretic administration using a 6.5 mg dose, and an 11 mg inhaled powder. 
     
     
         55 . The method according to  claim 51  wherein a C max  of sumatriptan delivered to the patient has a value that is at least double that compared to a C max  value of sumatriptan delivered to the patient using a delivery method selected from the group consisting of a 20 mg nasal spray, an iontophoretic administration using a 6.5 mg dose, and an 11 mg inhaled powder. 
     
     
         56 . The method according to  claim 51  wherein the delivery of sumatriptan to the patient provides at least one of a T max  of less than 30 minutes, an AUC t  of at least 9,000 ng·min/mL, a C max  of from 60 to 100 ng/mL, and a C ss  of from 30 to 60 ng/mL.