Claims for Patent: 8,778,393

Summary for Patent: 8,778,393

Title:	Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Abstract:	Compositions, methods and systems for administration of small volume sufentanil-containing drug dosage forms to the oral mucosa of a subject are disclosed.
Inventor(s):	Palmer; Pamela (San Francisco, CA), Schreck; Thomas (Portola Valley, CA), Tzannis; Stelios (Newark, CA), Hamel; Larry (Mountain View, CA), Poutiatine; Andrew I. (San Anselmo, CA), Rampersaud; Charles (San Francisco, CA), Edwards; Bruce (Menlo Park, CA)
Assignee:	AcelRx Pharmaceuticals, Inc. (Redwood City, CA)
Application Number:	13/555,948
Patent Claims:	1. A method of treating pain in a subject, comprising administering a dosage form to the oral mucosa of a subject, wherein said dosage form comprises: from about 5 to about 100 micrograms (mcg) of sufentanil, and a bioadhesive material, wherein: (i) said bioadhesive material adheres the dosage form to the oral mucosa of said subject during the period of drug delivery; (ii) said dosage form has a volume of less than 30 microliters or a mass of less than 30 mg; and (iii) after administration of said dosage form to said subject, said dosage form provides a minimal saliva response and minimal swallowing of sufentanil; at least 55% of drug delivery of sufentanil occurs via the oral transmucosal route; said dosage form provides a dose-normalized mean C.sub.max of 1.59-2.75 pg/mL per mcg dosed; said dosage form provides a T.sub.max of from about 19.8 minutes to about 60 minutes; and said dosage form provides a T.sub.max with a coefficient of variation of less than 40%. 2. The method according to claim 1, wherein said dosage form comprises a dose of sufentanil selected from the group consisting of 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, 40 mcg, 50 mcg, 60 mcg, 70 mcg, 80 mcg and 100 mcg. 3. The method according to claim 1, wherein said dosage form has a mass of less than 10 mg or a volume of less than 10 .mu.l. 4. The method according to claim 1, wherein said oral transmucosal administration is sublingual or buccal administration. 5. The method according to claim 1, wherein said dosage form has an erosion time of from 30 seconds up to a time selected from the group consisting of 5 minutes, 10 minutes, 15 minutes and 30 minutes. 6. The method according to claim 4, wherein said dosage form delivers at least 60% of the total amount of sufentanil in said dosage form via the sublingual route. 7. The method according to claim 4, wherein a single sublingual administration of said dosage form to a subject results in a bioavailability of sufentanil of greater than 50%. 8. The method according to claim 4, wherein a single sublingual administration of said dosage form to a subject results in a bioavailability of sufentanil of greater than 60%. 9. The method according to claim 4, wherein a single sublingual administration of said dosage form to a subject results in a bioavailability of sufentanil of greater than 70%. 10. The method according to claim 4, wherein the bioavailability of sufentanil following repeated sublingual administrations of said dosage form to a subject, is greater than the bioavailability of sufentanil following a single sublingual administration to said subject. 11. The method according to claim 1, wherein said dosage form is selected from the group consisting of a lozenge, a pill, a tablet, a membrane and a strip. 12. The method according to claim 11, wherein said dosage form is a tablet. 13. The method according to claim 1, wherein said pain is acute pain, breakthrough pain or post-operative pain. 14. The method according to claim 13, wherein said pain is acute inpatient pain. 15. The method according to claim 13, wherein said pain is post-operative pain.