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# FDA Gives Feedback to Paratek on Antibiotic Study
- URL: https://www.fdaweb.com/fda-gives-feedback-to-paratek-on-antibiotic-study/
- Published: 2016-05-10T12:00:00.000Z
- Updated: 2026-09-14T21:01:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135621

> FDA has given positive feedback to Paratek Pharmaceuticals on the design of a proposed oral-only Phase 3 study of omadacycline for treating acute bacterial skin and skin structure infections (ABSSSI). In its feedback, the agency confirmed that a proposed comparator is acceptable and that the proposed study design would meet the requirements established in the FDA’s guidance for ABSSSI studies, the company says. “In addition, FDA noted that while the current single Phase 3 intravenous (IV)-to-oral ABSSSI study combined with the company’s ongoing single Phase 3 IV-to-oral community-acquired bacterial pneumonia (CABP) study strategy remains sufficient to support registration for both ABSSSI and CABP indications, this single oral-only ABSSSI study has the potential to be used in combination with the current IV-to-oral ABSSSI study as the basis for a new drug application (NDA) for an ABSSSI indication, if both studies achieve their primary endpoints,” it says.  
>  
> A current IV-to-oral ABSSSI study recently completed enrollment, and top-line data are expected as early as the end of June, Paratek says. The company currently plans to file an NDA for omadacycline in the first half of 2018 supported with its IV-to-oral ABSSSI registration study and its IV-to-oral CABP registration study, both of which are being conducted under Special Protocols Assessments with the agency.