Regulatory Focus™ > News Articles > FDA Releases Draft Guidance on Abdominal Infection Products

FDA Releases Draft Guidance on Abdominal Infection Products

Posted 28 September 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released a new draft guidance document pertaining to the development of new pharmaceutical therapies for the treatment of complicated intra-abdominal infections (cIAIs), clinically common infections encompassing a wide swath of types of bacteria and locations.

These infections are frequently diagnosed as intra-abdominal abscesses, perforations of the stomach or intestine, peritonitis, appendicitis with perforations or periappendiceal abscesses, and diverticulitis with performation, peritonitis or abscesses.

Because of the numerous causes and conditions associated with cIAIs, FDA acknowledged that developing therapies is "challenging," and will require a sponsor to have a well-defined target and understood mechanisms of action.

With an eye toward assisting sponsors, FDA's guidance makes a number of recommendations regarding efficacy endpoints and the design of clinical trials, noting that just a single, well-controlled Phase III clinical trial may be necessary for a product to show evidence of efficacy. FDA will assess as "effective" products that are able to completely resolve all symptoms and signs of the infection within 28 days.

Additional topics covered by the guidance include showing non-inferiority or superiority to existing treatments, which FDA said should be at the core of all clinical trials conducted on cIAIs. In this case, FDA defines "non-inferior" as any product within 10% of the comparator product's rate of efficacy 28 days after treatment.

The draft guidance also covers the prior or concurrent use of other antibiotic therapies, which FDA said should be discouraged in trials so as not to accidentally show the effects of another drug during treatment.

Comments on the draft guidance are due in 90 days.

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