The Food & Drug Administration will expedite its review of a small Durham company's experimental drug to treat a stomach ailment that afflicts diabetics.
It's a positive step for Tranzyme Pharma, one that could speed up how quickly it wins FDA approval for its first product.
The so-called "Fast Track" designation is used by the FDA for drugs with the potential to treat serious and unmet medical needs.
The treatment, known as TZP-102, still requires several years of more clinical testing for Tranzyme to prove the drug is safe and effective. The drug is designed to treat gastroparesis, a painful stomach condition that affects up to 60 percent of diabetics.
Tranzyme, run by CEO Vipin Garg, has raised $60 million in venture-capital financing to pay for its drug research and now has 35 employees. The company was founded in 2000 and moved to Durham from Alabama in 2002.
The company is seeking $30 million in additional venture funding, Garg said. Winning fast-track status could help Tranzyme attract additional investments, and the interest of larger partners.
The company also is mulling plans for an initial public offering "when the stock market conditions improve sufficiently to do so," Garg said.