| CPC A61K 31/167 (2013.01) [A61K 9/0043 (2013.01); A61M 11/00 (2013.01); A61M 2210/0618 (2013.01)] | 19 Claims |
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1. A method of treating pain associated with a condition selected from the group consisting of tri-geminal neuralgia, facial neuropathic pain, facial cancer induced neuropathic pain, migraine pain, and cluster headache pain, comprising
incorporating a preservative-free nasal spray formulation into a mechanical multi-dose nasal spray pump device, the nasal spray formulation consisting of from about 5% to about 30% w/v of a locally active sodium channel blocker or a pharmaceutically acceptable salt thereof, from about 0.25% to about 5% w/v of a buffering agent, an optional second active agent selected from the group consisting of epinephrine, ketamine, a vasodilator, an anticonvulsant drug, a muscle relaxant, and combinations of any of the foregoing, and from about 5 to about 99% w/v of a pharmaceutically acceptable carrier for nasal administration, the nasal spray formulation having a viscosity from about 0.8 to about 1.1 cps, the mechanical multi-dose nasal spray pump device spraying a unit dose of the nasal spray formulation in a wide plume to provide a mean spray angle from about 50 to about 95 degrees and small droplet size having a mean Dv 10 from about 10 to about 30 μm, a mean Dv50 from about 20 to about 60 μm, and a mean Dv90 from about 80 to about 120 μm when actuated, the unit dose when sprayed into the nasal cavity of a human patient being therapeutically effective to treat a condition selected from the group consisting of tri-geminal neuralgia, facial neuropathic pain, facial cancer induced neuropathic pain, migraine pain, and cluster headache pain.
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