22nd Century Group is seeking a fast-track review by the Food and Drug Administration of the very low nicotine cigarettes that it hopes to market as a tool to help smokers quit.
The Clarence company, which also filed an application for an "investigational new drug" with the FDA, expects to hear from the federal agency within a month on whether it has been granted an accelerated review.
Fast-track status could shave a year or two off the time 22nd Century would need to conduct all the required clinical trials and, if successful, gain FDA approval to bring its cigarettes to market as a prescription-based smoking cessation tool.
"Fast-track status is very important," said Henry Sicignano III, the company's president.
22nd Century hopes to begin a Phase II clinical trial this summer. In the best-case prospects, the company could receive FDA approval during the first quarter of 2013, Sicignano said.
While the Phase II trial is fully funded, Sicignano said the company expects to conduct another round of fundraising during the fourth quarter of this year or the first quarter of next year to garner about $15 million that would be used to fund the next step in the drug's development, a Phase III clinical trial, Sicignano said.
22nd Century is developing a genetically modified type of tobacco that has 95 percent less nicotine than so-called "light" cigarettes.
That would allow smokers who want to quit to continue smoking as much as they want under a six-week, prescription-only treatment program, while reducing their exposure to addictive nicotine.
In theory, that would make it easier for those smokers to wean themselves off cigarettes and eventually help them kick the habit for good.
About two of every five U.S. smokers try to quit each year, but only about 2 percent to 5 percent actually succeed in quitting in the long run. Giving up cigarettes for good typically takes eight to 11 attempts.