Published on March 17, 2010 at 10:05 AM
Nabi Biopharmaceuticals (Nasdaq:NABI) announced that it has initiated the second of two pivotal Phase III clinical trials for NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary vaccine to treat nicotine addiction and prevent smoking relapse. The FDA has agreed with Nabi on the study design, protocol and end points through a Special Protocol Assessment (SPA). The SPA forms a basic foundation to support approval of a New Drug Application. The Company also received scientific advice from the European Medicines Agency (EMEA) that confirms and supports the trial protocol.
"With the initiation of this study, we are now fully engaged in the pivotal clinical program that we believe will lead to the successful licensure of NicVAX," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "NicVAX has the potential to address one of the most significant unmet medical needs in the world today. We aim to fully realize the benefits of NicVAX for our shareholders and for people who wish to quit smoking and remain quit."
About Nabi Biopharmaceuticals
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Posted in: Drug Trial News | Medical Condition News
Tags: Abstinence, Addiction, Antibody, Brain, Dopamine, Exercise, New Drug Application, Nicotine, Nicotine Addiction, Smoking, Smoking Cessation, Vaccine