FDA Guidance Establishes Specific Recommendations for Ear Infection Therapies
A new guidance document released by the US Food and Drug Administration (FDA) is intended to assist sponsors developing therapies to treat bacterial ear infections.
The guidance, Acute Bacterial Otitis Media (ABOM): Developing Drugs for Treatment, finalizes the draft version of the same guidance, which was released in January 2008, and revised a 1998 guidance by a similar name.
"This guidance focuses on specific drug development and trial design issues that are unique to the study of ABOM," explains FDA. An otitis media is an inflammation of the middle ear-more commonly referred to as an ear infection-and is commonly caused by bacterial infections. Left untreated, the infections can cause rare but serious complications, such as meningitis or mastoiditis.
The guidance lays out specific recommendations regarding the design, population, dose selection, use of competitors, endpoints and procedures of clinical trials. More general clinical trial issues are left to previous guidance, such as the International Conference on Harmonisation's (ICH) E9 and E10 clinical trials guidelines.
Instead, the guidance focuses on the development of products with an eye toward ABOM-specific considerations.
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