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|Title:||Sublingual fentanyl spray and methods of use to treat pain|
|Abstract:||The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt 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 DEVELOPMENT COMPANY, INC. (Chandler, AZ)|
|Filing Date:||Feb 12, 2016|
|Claims:||1. A sublingual formulation comprising from about 0.1% to about 0.9% by weight fentanyl, a free base or a pharmaceutically acceptable salt thereof, or a derivative thereof, from about 20% to about 60% by weight ethanol and from about 4% to about 6% by weight propylene glycol. |
2. The composition of claim 1, wherein ethanol is at a concentration from about 50% to about 60%.
3. A method of treating pain comprising administering an effective amount of the formulation of claim 1.
4. The method of claim 3, wherein the pain is breakthrough pain.