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Abeille Submits AB-1001 Phase III Pivotal Efficacy Study Protocol For FDA Review |
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10 Aug 2006 |
Company Simultaneously Initiates Phase II Irritation and Sensitization Study
PRINCETON, NJ, USA | Aug 09, 2006 | Abeille Pharmaceuticals, Inc., a product development company focusing on the development and commercialization of novel dosage forms and unique, proprietary combinations of existing drugs, today announced the submission of its AB-1001 Phase III Pivotal Efficacy Study Protocol for review and comment by the FDA under a Special Protocol Assessment (SPA). AB-1001, is a transdermal patch for chemotherapy induced nausea and vomiting (CINV). 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 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. In addition to the submission of the Phase III protocol to the FDA, we have simultaneously initiated dosing for our Phase II Irritation and Sensitization study in 240 healthy volunteers, under an FDA approved Protocol."
"The achievement of these milestones is significant and it will enable Abeille to stay on track to initiate our pivotal Phase III efficacy trials by the end of year 2006," stated Suresh Borsadia, President and CEO. "We have maintained our momentum and continue to advance AB-1001 for an NDA filing in the second quarter of 2007. Abeille is currently in discussions with multiple companies globally for the commercialization of AB-1001. We believe this product will be an excellent revenue growth generator for companies active in the cancer supportive care area," continued Mr. Borsadia.
About Abeille Pharmaceuticals
Abeille Pharmaceuticals, Inc. is a privately-held pharmaceutical company based in Princeton, New Jersey. The Company is focused on the formulation of products by applying advanced delivery technologies to existing drugs. These advanced delivery technologies include oral controlled release and transdermal delivery systems. The new products may benefit patients by requiring a lower dose of medicine, reduced side effects and easier administration of medication, thereby encouraging a patient to use the medication as prescribed. Abeille is dedicated to the development and commercialization of products that address unmet medical needs and improve the quality of life for patients. The Company's initial focus will be on drugs used to treat oncology related discomforts, diabetes and metabolic disorders, and CNS.
SOURCE: Abeille Pharmaceuticals, Inc |
