Claims for Patent: 10,245,228

Summary for Patent: 10,245,228

Title:	Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Abstract:	Compositions, systems and methods for administration of small volume sufentanil drug dosage forms to the sublingual mucosa of a subject for treatment of pain using a device are disclosed.
Inventor(s):	Palmer; Pamela (San Francisco, CA), Schreck; Thomas (Portola Valley, CA), Tzannis; Stelios (Petaluma, CA), Hamel; Larry (Pacific Grove, CA), Poutiatine; Andrew I. (Mill Valley, CA)
Assignee:	AcelRx Pharmaceuticals, Inc. (Redwood City, CA)
Application Number:	15/655,316
Patent Claims:	1. A dosage form for oral transmucosal administration to a subject, comprising: from 5.0 micrograms to 100 micrograms sufentanil, wherein said dosage form is bioadhesive and has a volume of less than 30 microliters or a mass of less than 30 mg, wherein the administration of the dosage form to the subject provides a Tmax with a coefficient of variation less than 40%. 2. The dosage form of claim 1, wherein the dosage form has a volume of less than 10 microliters or a mass of less than 10 mg. 3. The dosage form of claim 1, wherein after administration of the dosage form to the subject, at least 50% of the drug delivery of sufentanil occurs via the oral transmucosal route. 4. The dosage form of claim 3, wherein after administration of the dosage form to the subject, at least 55% of the drug delivery of sufentanil occurs via the oral transmucosal route. 5. The dosage form of claim 3, wherein after administration of the dosage form to the subject, at least 60% of the drug delivery of sufentanil occurs via the oral transmucosal route. 6. The dosage form of claim 1, wherein after administration of the dosage form to the subject, the dosage form provides a T.sub.max of from about 19.8 minutes to about 60 minutes. 7. The dosage form of claim 1, wherein after administration of the dosage form to the subject results in a dose-normalized C.sub.max of about 2.72+/-0.84 pg/mL per mcg dosed. 8. The dosage form of claim 1, wherein after administration of the dosage form to the subject, the dosage form provides a T.sub.max of from about 19.8 minutes to about 60 minutes and a dose-normalized C.sub.max of about 2.72+/-0.84 pg/mL per mcg dosed. 9. The dosage form of claim 8, wherein the transmucosal administration is to the sublingual membrane. 10. The dosage form of claim 8, wherein the administration is to the buccal membrane. 11. The dosage form of claim 1, wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 65%. 12. The dosage form of claim 1, wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 75%. 13. The dosage form of claim 1, wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 80%. 14. The dosage form of claim 1, wherein sufentanil is sufentanil citrate. 15. A drug delivery device comprising the dosage form of claim 1. 16. A method of treating pain in a subject, comprising administering a dosage form to the oral mucosa of a subject, wherein said dosage form is bioadhesive and comprises 5.0 micrograms to 100 micrograms, sufentanil, wherein said dosage form is bioadhesive and has a volume of less than 30 microliters or a mass of less than 30 mg. 17. The method of claim 16, wherein the dosage form has a volume of less than 10 microliters or a mass of less than 10 mg. 18. The method of claim 16, wherein the administration of the dosage form to the subject provides a T.sub.max with a coefficient of variation less than 40%. 19. The method of claim 16, wherein after administration of the dosage form to the subject, the dosage form provides a T.sub.max of from about 19.8 minutes to about 60 minutes. 20. The method of claim 16, wherein after administration of the dosage form to the subject, at least 50% of the drug delivery of sufentanil occurs via the oral transmucosal route. 21. The method of claim 16, wherein after administration of the dosage form to the subject, at least 55% of the drug delivery of sufentanil occurs via the oral transmucosal route. 22. The method of claim 16, wherein after administration of the dosage form to the subject, at least 60% of the drug delivery of sufentanil occurs via the oral transmucosal route.