Patent ID: 7648981

Claim:
A pain management method enabling a pain sufferer to self-medicate by repeated dosing with an opioid formulation to achieve analgesia while avoiding toxicity, wherein the method relies solely on the actions of the pain sufferer to manage intake of said opioid during the medication process, said method comprising the steps of: the pain sufferer continuously inhaling the formulation using a pulmonary drug delivery device to produce analgesia; and stopping inhalation during the medication process when satisfactory analgesia is achieved or at the onset of a side effect; wherein the formulation comprises fentanyl and liposomally encapsulated fentanyl; the concentration of said fentanyl and liposomally encapsulated fentanyl, and amount of and particle size of the formulation delivered from the device on each inhalation, being selected so that, during inhalation, analgesia is achieved before the onset of said side effect, and the onset of said side effect occurs before the onset of toxicity, and so that the maximum total opioid plasma concentration does not reach toxic levels, whereby the onset of said side effect can be used by the pain sufferer to terminate inhalation to avoid toxicity, wherein the ratio of said fentanyl to liposomally encapsulated fentanyl is selected such that a combined pharmacokinetic profile of the fentanyl and the liposomally encapsulated fentanyl has a combined effect curve providing a peak concentration at an effect site at between 10 and 30 minutes and a concentration at the effect site of a magnitude of at least 85% of said peak concentration for at least 2 hours.