ROCKVILLE, Md., March 9 (UPI) -- Nabi Biopharmaceuticals said Thursday it has received fast-track status for NicVAX for nicotine addiction and smoking relapse.
The designation means Nabi's nicotine conjugate vaccine could be reviewed by the Food and Drug Administration within six months.
Fast-track status also allows the company to rely on surrogate endpoints, or evidence collected at an earlier point in the clinical study, to demonstrate the vaccine's safety and efficacy.
"We believe this is the first Fast Track Designation for a smoking cessation product candidate, which is unprecedented, and provides further validation for our unique approach to addressing nicotine addiction," said Henrik Rasmussen, senior vice president, clinical, medical and regulatory affairs at Nabi Biopharmaceuticals.
"Smoking is the number one preventable cause of death in the western world, yet current smoking cessation therapies do not effectively treat the root cause of the addiction. We believe the vaccine approach inherent to NicVAX will provide clear patient advantages and a strong differentiation from currently marketed and development-stage products," he said.
NicVAX causes the body's immune system to produce antibodies that bind to nicotine and prevent it from entering the brain, the company said.
Since the antibodies remain in the body for a long period of time, the vaccine's effects are not dependent upon continued treatment, as with smoking cessation patches and gums, the company said.
Nabi said it has wrapped up four Phase 1/2 studies involving about 200 patients that showed a 33-percent to 40-percent quit rate, compared to 9 percent taking placebo.