ALM101: Intranasal Granisetron for the Treatment of Chemotherapy Induced Nausea and Vomiting (CINV)

来源 :BITs 3rd Annual World Cancer Congress-2012(2012第五届世界癌症大会) | 被引量 : 0次 | 上传用户:mohang
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  Chemotherapy-induced nausea and vomiting (CINV) is experienced by around 80% of patients currently receiving chemotherapy.Acute CINV typically occurs within minutes or hours of drug administration, lasting for up to 24 hours.5-HT3 antagonists such as granisetron are often first choice therapies but currently have to be administered orally or via Ⅳ injection.Ⅳ administration is restricted to the hospital setting.Oral administration may not be ideal in patients who are experiencing nausea or who have difficulty swallowing because they have head and neck cancer or are suffering from mucositis.Almac Discovery and Archimedes Pharma have developed an intranasal formulation of granisetron using Archimedes proprietary ChiSys(R) delivery technology, which has the potential to afford patients a safe, convenient and well tolerated alternative to currently available granisetron treatments.A clinical study was conducted in 14 healthy volunteers using a crossover design, comparing the pharmacokinetics (PK), safety and local tolerability of the intranasal granisetron with standard oral and intravenous administration.The novel intranasal granisetron spray was shown to be safe and well tolerated and exhibited excellent PK properties.A 2mg dose of intranasal granisetron had an absolute bioavailability of 83% and a Tmax of 0.30 hours compared with a 2mg oral dose, which had an absolute bioavailability of 64% and a Tmax of 1.57 hours.Intranasal granisetron utilizing ChySys technology therefore has the potential to present the patient with an effective and convenient alternative treatment for CINV and has several potential advantages over oral and/or intravenously administered granisetron therapy for this indication.
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