Bupropion as a modulator of drug activity
AssigneeAntecip Bioventures II LLC
InventorHerriot Tabuteau
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Abstract
This disclosure relates to administration of a combination of: 1) about 100-110 mg, about 104-106 mg, or about 105 mg or less of bupropion hydrochloride, or a molar equivalent amount of the free base form or another salt form of bupropion; and 2) about 40-50 mg, about 44-46 mg, or about 45 mg or less of dextromethorphan hydrobromide, or a molar equivalent amount of the free base form or another salt form of dextromethorphan in human patients for treating neurological and psychiatric conditions, such as agitation associated Alzheimer's disease and/or reducing relapse of agitation in Alzheimer's disease.
Claims16
A method of treating agitation associated with dementia due to Alzheimer's disease in a human patient who is experiencing agitation in Alzheimer's disease (AD), comprising 1) orally administering a first dosage form once daily for one week to the human patient, then administering the first dosage form twice daily to the human patient for one week;
- and 2) then orally administering a second dosage form twice daily to the human patient for at least one week;
- wherein the first dosage form comprises about 30 mg of dextromethorphan hydrobromide, or a molar equivalent amount of another salt form of dextromethorphan or the free base form of dextromethorphan, about 105 mg of bupropion hydrochloride, or a molar equivalent amount of another salt form of bupropion or the free base form of bupropion, and a polymer;
- wherein the second dosage form comprises about 45 mg of dextromethorphan hydrobromide, or a molar equivalent amount of another salt form of dextromethorphan or the free base form of dextromethorphan, and about 105 mg of bupropion hydrochloride, or a molar equivalent amount of another salt form of bupropion or the free base form of bupropion, and a polymer;
- and
- wherein after the human patient has experienced a sustained clinical response as a result of receiving treatment with the first dosage form and the second dosage form, administration of the second dosage form twice daily is continued;
- wherein a sustained clinical response comprises a 30% or greater improvement from baseline in the human patient's Cohen-Mansfield Agitation Inventory (CMAI) total score which is maintained for at least 4 consecutive weeks, and maintaining a Patient Global Impression of Change (PGI-C) score of 3 or less for at least 4 consecutive weeks.
Dependencies are inferred from the claim text.