ABS sticking point
By releasing its second guidance for anti-infectives within a month, FDA last week made good on its obligation to provide clarity on the requirements for drugs intended to treat acute bacterial sinusitis. But by layering a new recommendation for the use of sinus puncture and aspiration on top of the expected requirement for placebo-controlled or superiority trials, critics say the draft guidelines may have set the bar impractically high.
The guidance gives four options for trial design that may make patient recruitment less difficult than an outright requirement for placebo controls, and gives what the agency says is a viable approach for comparing the test drug to an active comparator (see BioCentury Sept. 18, 2006, Oct. 30, 2006, & Oct. 29, 2007).
The first option is for placebo-controlled studies with