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Method of administering amantadine prior to a sleep period

DC
  • US 9,867,791 B2
  • Filed: 02/09/2017
  • Issued: 01/16/2018
  • Est. Priority Date: 12/02/2009
  • Status: Active Grant
First Claim
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1. A method of administering a dose of a pharmaceutical composition of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof to a human patient in need thereof, comprising administering said dose of said pharmaceutical composition to said human patient orally, once daily 0 to 4 hours before bedtime, wherein said dose of said pharmaceutical composition comprises:

  • (i) 250 mg to 600 mg of the drug; and

    (ii) one or more excipients, wherein at least one of said one or more excipients modifies the release of said drug to provide an extended release dosage form, andwherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the fractional AUC0-4 for amantadine is less than 5% of AUC0-inf and the Tmax of amantadine is 8 to 20 hours.

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