The regulator confirmed that the proposed comparator is acceptable and the trial design would meet the requirements established in its guidance for ABSSSI studies.
In addition, the FDA noted that the existing single Phase 3 intravenous (IV)-to-oral ABSSSI study combined with Paratek’s ongoing single Phase 3 IV-to-oral CABP trial strategy will be adequate to support registration for both ABSSSI and CABP indications.
According to the agency, the single oral-only ABSSSI trial 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.
Patient enrollment has been completed in the current IV-to-oral ABSSSI study, and top-line data is anticipated as early as the end of June.
Paratek intends to file its NDA for omadacycline in the first half of 2018 with its IV-to-oral ABSSSI registration study and its IV-to-oral CABP registration trial, both of which are being carried out under special protocols assessments with the FDA.
The company said a successful outcome in each of the studies would support the approval for both indications for the once-daily oral and IV formulations of omadacycline.
Omadacycline is a new once-daily oral and IV, well-tolerated broad-spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from severe community-acquired bacterial infections.
Earlier this month, Paratek started a phase 1b study of omadacycline in urinary tract infections. The FDA granted fast track status to omadacycline.