Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain

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 Cmax of 1.59-2.75 pg/mL per mcg dosed;
• said dosage form provides a Tmax of from about 19.8 minutes to about 60 minutes;
• and
• said dosage form provides a Tmax with a coefficient of variation of less than 40%.