Purdue Pharma L. P.
`
`Appl. No. 15/442,231
`
`Amendments to the Claims
`
`This listing of claims will replace all prior versions, and listings, of claims in the application.
`
`1.
`
`(Currently Amended) A method of treating pain in a subject in need thereof, the method
`
`comprising contacting an oral mucosal surface of the subject
`
`in need thereof with a
`
`mucoadhesive 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 2.5 ng/ml and an average buprenorphine AUC0_48 of less than 15 (hrs*ng)/ml,
`
`b)
`
`at least one non-gelatin polymeric film-forming material selected from the group
`
`consisting
`
`of
`
`carboxymethylcellulose
`
`sodium,
`
`hydroxyethylcellulose,
`
`hydroxypropylcellulose, and combinations thereof, in which the buprenorphine or
`
`the equivalent amount of the pharmaceutically acceptable salt thereof is dissolved or
`
`homogeneously dispersed,
`
`wherein
`
`within less than 5 minutes after contacting the subject's oral mucosal surface with the
`
`mucoadhesive film dosage form, substantially all of the buprenorphine or the
`
`pharmaceutically acceptable salt thereof contacts the mucosal surface of the subject's
`
`oral cavity, and
`
`Atty. Dkt. No.:
`1861.2700005/JMC/MSB
`
`
`
`Purdue Pharma L. P.
`
`Appl. No. 15/442,231
`
`wherein the dosage form does not
`
`
`include naloxone
`naltrexone nalmefene
`
`nalopphine,
`
`nalbuphine,
`
`naloxoneazinen, methylnaltrexone,
`
`ketylcyclazocine,
`
`norbinaltor himine
`
`naltrindol
`
`6- -naloxol
`
`6- -naltrexol
`
`or
`
`other
`
`0 ioid
`
`antagonists capable of inducing opioid withdrawal symptoms upon parenteral
`
`administration with buprenorphine.
`
`an—epi-ei-d—an-t—ageni—st.
`
`(Currently Amended) The method of claim 1, wherein th_emucoadhesive film dosage form
`
`further comprises a pH modifier.
`
`(Currently Amended) The method of claim 2, wherein th_emucoadhesive the—pH modifier is
`
`selected from the group consisting of citric acid, tartaric acid, phosphoric acid, hydrochloric
`
`acid, and maleic acid.
`
`(Currently Amended) The method of claim 1, wherein th_emucoadhesive the—film dosage
`
`form further comprises at least one of sodium dihydrogen or disodiumhydrogen phosphate,
`
`sodium tartrate, sodium ascorbate, citric acid, tartartic acid, adipinic acid, ascorbic acid,
`
`acetic acid, or lactic acid.
`
`(Original) The method of claim 1, wherein the mucoadhesive film dosage form achieves a
`
`buprenorphine tmaX from approximately 45 to approximately 90 minutes.
`
`(Original) The method of claim 1, wherein the mucoadhesive film dosage form is
`
`administered once a day, every two days, every three days, or less frequently.
`
`Atty. Dkt. No.:
`1861.2700005/JMC/MSB
`
`
`
`Purdue Pharma L. P.
`
`Appl. No. 15/442,231
`
`(Original) The method of claim 1, wherein the mucoadhesive film dosage form further
`
`comprises a flavoring agent.
`
`(Currently Amended) The method of claim 7, wherein the flavoring agent is selected from
`
`the group consisting of mint, raspberry, licorice, orange, lemon, grapefruit, caramel, vanilla,
`
`cherry, cherry—grape, and combinations thereof.
`
`Atty. Dkt. No.:
`1861.2700005/JMC/MSB
`
`
