Buprenorphine wafer for drug substitution therapy

A film dosage form for trans-mucosal medication-assisted treatment for opioid addiction, the film dosage form comprising:

• a) an amount of buprenorphine, or an equivalent amount of a pharmaceutically acceptable salt thereof, sufficient to provide an average buprenorphine Cmax of less than about 7 ng/ml and an average buprenorphine AUC0-48 of less than 40 (hrs*ng)/ml;
• b) naloxone or a pharmaceutically acceptable salt thereof;
• and
• c) at least one non-gelatin polymeric film-forming material in which the buprenorphine or the equivalent amount of the pharmaceutically acceptable salt thereof and the naloxone or the pharmaceutically acceptable salt thereof, are dissolved or homogeneously dispersed;
• the buprenorphine or the equivalent amount of the pharmaceutically acceptable salt thereof and the naloxone or the pharmaceutically acceptable salt thereof being present in the film dosage form in a weight ratio of from 1:1 to 10:1;
• wherein, the film dosage form releases substantially all of the buprenorphine or the pharmaceutically acceptable salt thereof and approximately substantially all of the naloxone or the pharmaceutically acceptable salt thereof into contact with a mucosal surface of the oral cavity within less than 5 minutes after contacting the mucosal surface.