# US 2014/0194395 A1 · Compositions and methods for treating centrally mediated nausea and vomiting

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- Number: US 2014/0194395 A1
- Document ID: US20140194395A1
- Status: Published application
- Kind: A1
- Application number: 14/069,927
- Filed: 2013-11-01
- Published: 2014-07-10
- Earliest claimed: 2009-11-18
- Assignees: Helsinn Healthcare SA
- Applicants: Helsinn Healthcare S.A.
- Inventors: Fabio TRENTO; Sergio CANTOREGGI; Giorgia ROSSI; Roberta CANNELLA; Daniele BONADEO
- Web page: https://patentgrep.com/patent/US20140194395A1

## CPC

- A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)}
- A61K 9/4858: {Organic compounds}
- A61K 31/4178: not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
- A61K 31/473: ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
- A61K 31/573: substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 1/08: for nausea, cinetosis or vertigo; Antiemetics
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Provided are compositions and methods for treating or preventing nausea and vomiting in patients undergoing chemotherapy, radiotherapy, or surgery.

## Claims

### Claim at position 1

1-51. (canceled)

### Claim 52

52) A method of treating chemotherapy induced nausea and vomiting (CINV) comprising administering to a subject receiving chemotherapy a regimen of palonosetron, netupitant and dexamethasone.

### Claim 53

53) A method of treating chemotherapy induced nausea and vomiting (CINV) in a subject receiving chemotherapy comprising administering to a subject receiving chemotherapy a regimen of netupitant and a sub-therapeutic dose of dexamethasone.

### Claim 54 (depends on 53)

54) The method of claim 53, wherein the sub-therapeutic dose of dexamethasone comprises from about 50 to 70% of a minimum effective dose when administered alone against CINV.

### Claim 55

55) A method of treating chemotherapy induced nausea and vomiting (CINV) comprising inducing in a subject receiving chemotherapy blood levels of palonosetron and netupitant effective to treat said CINV.

### Claim 56 (depends on 52)

56) The method of claim 52, wherein the chemotherapy comprises moderately or highly emetogenic chemotherapy.

### Claim 57 (depends on 52)

57) The method of claim 52, wherein said chemotherapy comprises carboplatin.

### Claim 58 (depends on 52)

58) The method of claim 52, wherein the netupitant and palonosetron are administered no more than one hour prior to administration of the chemotherapy.

### Claim 59 (depends on 52)

59) The method of claim 52, wherein when said chemotherapy is highly emetic chemotherapy, the chemotherapy is selected from the group consisting of carmustine, cisplatin, cyclophosphamide≧1500 mg/m2, dacarbazine, dactinomycin, mechlorethamine, streptozotocin and combinations thereof.

### Claim 60 (depends on 52)

60) The method of claim 52, wherein when said chemotherapy is moderately emetic chemotherapy, the chemotherapy is selected from the group consisting of carboplatin, cyclophosphamide<1500 mg/m2, cytarabine>1 mg/m2, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, oxaliplatin and combinations thereof.

### Claim 61 (depends on 52)

61) The method of claim 52, wherein said chemotherapy is selected from the group consisting of carboplatin, cyclophosphamide, cytarabine>1 mg/m2, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, carmustine, cisplatin, dacarbazine, dactinomycin, mechlorethamine, streptozotocin, oxaliplatin and combinations thereof.

### Claim 62 (depends on 53)

62) The method of claim 53, wherein when said chemotherapy is highly emetic chemotherapy, the chemotherapy is selected from the group consisting of carmustine, cisplatin, cyclophosphamide≧1500 mg/m2, dacarbazine, dactinomycin, mechlorethamine, streptozotocin and combinations thereof.

### Claim 63 (depends on 53)

63) The method of claim 53, wherein when said chemotherapy is moderately emetic chemotherapy, the chemotherapy is selected from the group consisting of carboplatin, cyclophosphamide<1500 mg/m2, cytarabine>1 mg/m2, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, oxaliplatin and combinations thereof.

### Claim 64 (depends on 53)

64) The method of claim 53, wherein said chemotherapy is selected from the group consisting of carboplatin, cyclophosphamide, cytarabine>1 mg/m2, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, carmustine, cisplatin, dacarbazine, dactinomycin, mechlorethamine, streptozotocin, oxaliplatin and combinations thereof.

### Claim 65 (depends on 55)

65) The method of claim 55, wherein when said chemotherapy is highly emetic chemotherapy, the chemotherapy is selected from the group consisting of carmustine, cisplatin, cyclophosphamide≧1500 mg/m2, dacarbazine, dactinomycin, mechlorethamine, streptozotocin and combinations thereof.

### Claim 66 (depends on 55)

66) The method of claim 55, wherein when said chemotherapy is moderately emetic chemotherapy, the chemotherapy is selected from the group consisting of carboplatin, cyclophosphamide<1500 mg/m2, cytarabine>1 mg/m2, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, oxaliplatin and combinations thereof.

### Claim 67 (depends on 55)

67) The method of claim 55, wherein said chemotherapy is selected from the group consisting of carboplatin, cyclophosphamide, cytarabine>1 mg/m2, daunorubicin, doxorubicin, epirubicin, idarubicin, ifosfamide, irinotecan, carmustine, cisplatin, dacarbazine, dactinomycin, mechlorethamine, streptozotocin, oxaliplatin and combinations thereof.