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Aug12
Phase III Pivotal Efficacy Study Protocol for Abeille Pharma Inc.’s AB-1001, Submitted to the USFDA for Review

Abeille Pharmaceuticals, Inc. recently submitted its AB-1001 Phase III Pivotal Efficacy Study Protocol for review and comment by the USFDA under a Special Protocol Assessment (SPA).

AB-1001, a transdermal patch for chemotherapy induced nausea and vomiting (CINV) 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 CINV.

"We are pleased with the progress we have been able to sustain for our lead product, AB-1001," stated Dr. Kalpana Patel, Vice President, Strategic Planning and Alliance Management.

"The objective of the Phase III study is to determine the comparative safety and efficacy of AB-1001 with currently approved therapy for acute and delayed nausea and vomiting in emetogenic chemotherapy.

Read more at Abeille Pharmaceuticals, Inc.

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