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Generated: December 11, 2017

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Title:Compositions and methods for treating centrally mediated nausea and vomiting
Abstract: Provided are compositions and methods for treating or preventing nausea and vomiting in patients undergoing chemotherapy, radiotherapy, or surgery.
Inventor(s): Trento; Fabio (Como, IT), Cantoreggi; Sergio (Cagiallo, CH), Rossi; Giorgia (Como, IT), Cannella; Roberta (Varese, IT), Bonadeo; Daniele (Varese, IT)
Assignee: HELSINN HEALTHCARE SA (Lugano/Pazzallo, CH)
Filing Date:Nov 01, 2013
Application Number:14/069,970
Claims:1. A method of achieving no emesis during the overall phase in a human subject in need thereof comprising administering to said subject an oral dosage form, no more than one hour prior to administration of moderately or highly emetogenic chemotherapy, comprising a therapeutically effective amount of a) netupitant and b) palonosetron, or pharmaceutically acceptable salts thereof, wherein no emesis is obtained, as measured by no emetic episodes occurring within at least about 120 hours after the start of the moderately or highly emetogenic chemotherapy.

2. A method of achieving no emesis during the acute phase in a human subject in need thereof comprising administering to said subject an oral dosage form, no more than one hour prior to administration of moderately or highly emetogenic chemotherapy, comprising a therapeutically effective amount of a) netupitant and b) palonosetron, or pharmaceutically acceptable salts thereof, wherein no emesis is obtained, as measured by no emetic episodes occurring within at least about 24 hours after the start of the moderately or highly emetogenic chemotherapy.

3. A method of achieving no emesis during the delayed phase in a human subject in need thereof comprising administering to said subject an oral dosage form, no more than one hour prior to administration of moderately or highly emetogenic chemotherapy, comprising a therapeutically effective amount of a) netupitant and b) palonosetron, or pharmaceutically acceptable salts thereof, wherein no emesis is obtained, as measured by no emetic episodes occurring within at least about 24 to 120 hours after the start of the moderately or highly emetogenic chemotherapy.

4. A method of achieving no significant nausea during the overall phase in a human subject in need thereof comprising administering to said subject an oral dosage form, no more than one hour prior to administration of moderately or highly emetogenic chemotherapy, comprising a therapeutically effective amount of a) netupitant and b) palonosetron, or pharmaceutically acceptable salts thereof, wherein no significant nausea is obtained, as measured by a maximum VAS <25 mm within at least about 120 hours after the start of the moderately or highly emetogenic chemotherapy.

5. A method of achieving no significant nausea during the acute phase in a human subject in need thereof comprising administering to said subject an oral dosage form, no more than one hour prior to administration of moderately or highly emetogenic chemotherapy, comprising a therapeutically effective amount of a) netupitant and b) palonosetron, or pharmaceutically acceptable salts thereof, wherein no significant nausea is obtained, as measured by a maximum VAS <25 mm within at least about 24 hours after the start of the moderately or highly emetogenic chemotherapy.

6. A method of achieving no significant nausea during the delayed phase in a human subject in need thereof comprising administering to said subject an oral dosage form, no more than one hour prior to administration of moderately or highly emetogenic chemotherapy, comprising a therapeutically effective amount of a) netupitant and b) palonosetron, or pharmaceutically acceptable salts thereof, wherein no significant nausea is obtained, as measured by a maximum VAS <25 mm within at least about 24 to 120 hours after the start of the moderately or highly emetogenic chemotherapy.

7. A method of achieving no nausea during the delayed phase in a human subject in need thereof comprising administering to said subject an oral dosage form, no more than one hour prior to administration of moderately or highly emetogenic chemotherapy, comprising a therapeutically effective amount of a) netupitant and b) palonosetron, or pharmaceutically acceptable salts thereof, wherein no nausea is obtained, as measured by a maximum VAS <5 mm within at least about 24 to 120 hours after the start of the moderately or highly emetogenic chemotherapy.

8. The method of claim 1, wherein the oral dosage form comprises about 300 mg netupitant and about 0.5 mg palonosetron hydrochloride based on the weight of the free base.

9. The method of claim 1, wherein the chemotherapy comprises carboplatin.

10. The method of claim 1, wherein when said chemotherapy is highly emetic chemotherapy, the chemotherapy is selected from the group consisting of carmustine, cisplatin, cyclophosphamide .gtoreq.1500 mg/m.sup.2, dacarbazine, dactinomycin, mechlorethamine, streptozotocin and combinations thereof.

11. The method of claim 1, wherein when said chemotherapy is moderately emetic chemotherapy, the chemotherapy is selected from the group consisting of carboplatin, cyclophosphamide <1500 mg/m.sup.2, cytarabine >1 mg/m.sup.2, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, oxaliplatin and combinations thereof.

12. The method of claim 1, wherein said chemotherapy is selected from the group consisting of carboplatin, cyclophosphamide, cytarabine >1 mg/m.sup.2, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, carmustine, cisplatin, dacarbazine, dactinomycin, mechlorethamine, streptozotocin, oxaliplatin and combinations thereof.
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