Sublingual fentanyl spray and methods of use to treat pain
View Patent ↗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.
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.