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news.Abeille Pharmaceuticals has submitted the study protocol for a pivotal phase III efficacy study of its chemotherapy-induced nausea and vomiting patch, AB-1001, for review and comment by the FDA.
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AB-1001 is designed to deliver a commercially available 5HT3-antagonist through the skin for a continuous period of up to five days, thereby providing the patient with sustained relief for chemotherapy-induced nausea and vomiting (CINV).
The phase III study has been designed to determine the safety and efficacy of AB-1001 compared to currently approved therapy in acute and delayed nausea and vomiting in emetogenic chemotherapy. The trial protocol has been submitted under a special protocol assessment.
In addition to the filing, Abeille has begun dosing in its phase II irritation and sensitization study, which has enrolled 240 healthy volunteers.
Abeille hopes to initiate the phase III trial by the end of the year, and is aiming to file a new drug application for the patch in the second quarter of 2007. The company also revealed that it is currently in discussions with various companies regarding the future commercialization of AB-1001.