Nabi Biopharmaceuticals has reached agreement with the US Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a pivotal phase-3 clinical trial of NicVAX (Nicotine Conjugate Vaccine), the company's innovative and proprietary investigational vaccine to treat nicotine addiction and prevent smoking relapse. The SPA is a process by which sponsors and the FDA reach agreement on the design and size of clinical trials. It is intended to form the basic foundation to support approval of a New Drug Application.
"We are very pleased to reach agreement with the FDA on this very important and pivotal trial protocol. This SPA provides us with a clear, well-defined path to support approval of NicVAX and further strengthens our leadership position to bring the first smoking cessation vaccine to market," said Dr Raafat Fahim, president and chief executive officer of Nabi Biopharmaceuticals. "Ideally, we would prefer to initiate phase-3 testing with a strategic partner and we continue to pursue all options through our strategic alternatives process. The SPA further reduces the regulatory risks associated with the NicVAX programme for both Nabi and its potential partners. Smoking cessation represents a critical unmet medical need and a significant market opportunity for a safe and effective vaccine product."
NicVAX is an innovative and proprietary investigational vaccine being developed by Nabi to treat nicotine addiction and prevent smoking relapse.
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop products that target serious medical conditions in the areas of nicotine addiction and gram-positive bacterial infections.