Claims for Patent: 11,839,612

Summary for Patent: 11,839,612

Title:	Compounds and combinations thereof for treating neurological and psychiatric conditions
Abstract:	This disclosure relates to administration of a combination of: 1) about 100-110 mg, about 104-106 mg, or about 105 mg of bupropion hydrochloride, or a molar equivalent amount of a free base form or another salt form of bupropion; and 2) about 40-50 mg, about 44-46 mg, or about 45 mg of dextromethorphan hydrobromide, or a molar equivalent amount of a free base form or another salt form of dextromethorphan in certain patient populations, such as patients having moderate renal impairment, patients receiving a concomitant strong CYP2D6 inhibitor, patients who are known CYP2D6 poor metabolizers, those in need of an NMDA antagonist that does not cause dissociation, and those at risk of QT prolongation.
Inventor(s):	Herriot Tabuteau
Assignee:	Antecip Bioventures II LLC
Application Number:	US18/177,585
Patent Claims:	1. A method of treating major depressive disorder in a human patient who requires concomitant treatment with paroxetine, comprising administering, once daily to the human patient, a combination of about 105 mg of bupropion hydrochloride and about 45 mg of dextromethorphan hydrobromide, wherein the human patient is experiencing major depressive disorder and is receiving concomitant treatment with paroxetine, wherein the combination is present in a solid dosage form, wherein the solid dosage form is orally administered in the morning, wherein the dextromethorphan is in an immediate-release formulation, wherein the bupropion is in an extended-release formulation, and wherein the solid dosage form further contains L-cysteine hydrochloride monohydrate. 2. The method of claim 1, wherein the once-daily administration avoids the human patient having an about 2.7-fold increase in AUC0-12 of dextromethorphan as compared to the AUC0-12 of dextromethorphan that would result after 8 days of twice daily administration of the solid dosage form to the human patient without the concomitant treatment with paroxetine. 3. The method of claim 1, wherein the once-daily administration avoids the human patient having an about 2.4-fold increase in Cmax of dextromethorphan as compared to the Cmax of dextromethorphan that would result after 8 days of twice daily administration of the solid dosage form to the human patient without the concomitant treatment with paroxetine. 4. The method of claim 1, wherein the solid dosage form further contains a carbomer homopolymer. 5. The method of claim 1, wherein the solid dosage form further contains colloidal silicon dioxide. 6. The method of claim 1, wherein the solid dosage form further contains crospovidone. 7. The method of claim 1, wherein the solid dosage form further contains glyceryl monocaprylocaprate. 8. The method of claim 1, wherein the solid dosage form further contains magnesium stearate. 9. The method of claim 1, wherein the solid dosage form further contains microcrystalline cellulose. 10. The method of claim 1, wherein the solid dosage form further contains polyvinyl alcohol. 11. The method of claim 1, wherein the solid dosage form further contains red iron oxide. 12. The method of claim 1, wherein the solid dosage form further contains sodium lauryl sulfate. 13. The method of claim 1, wherein the solid dosage form further contains stearic acid. 14. The method of claim 1, wherein the solid dosage form further contains talc. 15. The method of claim 1, wherein the solid dosage form further contains titanium dioxide. 16. The method of claim 1, wherein the solid dosage form further contains yellow iron oxide. 17. The method of claim 1, wherein administration of the solid dosage form twice daily to the human patient for 8 days would result in the human patient having about the same AUC0-12 of bupropion as compared to the AUC0-12 of bupropion that would result after 8 days of twice daily administration of the solid dosage form to a human patient without the concomitant treatment with paroxetine. 18. The method of claim 1, wherein administration of the solid dosage form twice daily to the human patient for 8 days would result in the human patient having about the same Cmax of bupropion as compared to the Cmax of bupropion that would result after 8 days of twice daily administration of the solid dosage form to a human patient without the concomitant treatment with paroxetine.