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Claims for Patent: 9,241,935

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Claims for Patent: 9,241,935

Title:Sublingual fentanyl spray
Abstract: The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Inventor(s): Kottayil; S. George (Long Grove, IL), Goskonda; Venkat R. (Phoenix, AZ), Zhu; Zhongyuan (Vernon Hills, IL), Kattookaran; Linet (Mount Prospect, IL), Parikh; Neha (Chicago, IL)
Assignee: Insys Pharma, Inc. (Chandler, AZ)
Application Number:14/448,752
Patent Claims: 1. A sublingual spray formulation comprising a dose of fentanyl which provides one or more mean pharmacokinetic values selected from the group consisting of: AUClast 4.863+/-1.70821 hr*ng/mL, AUCinf 5.761+/-1.916 hr*ng/milliliter, and AUCextrap 10.26+/-5.66%, when administered to humans.

2. A sublingual spray formulation comprising a dose of fentanyl, a free base or a pharmaceutically acceptable salt thereof, which provides a substantially dose proportional mean AUClast based on a mean AUClast of about 4.863+/-1.70821 hr*ng/milliliter when administered to humans.

3. A sublingual spray formulation comprising a dose of fentanyl, a free base or a pharmaceutically acceptable salt thereof, which provides a mean F(AUClast) of about 0.721+/-0.199 ng/milliliter when administered to humans.
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