Sun Pharma Told to Revise Delafloxacin Phase III Trial Protocol

Sun Pharma had proposed a Phase III, multicentre, randomized, open-label, active-controlled clinical trial to evaluate the efficacy and safety of Delafloxacin (injection and tablets) in comparison with Linezolid (injection and tablets) and Aztreonam injection in patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The firm also presented its BE study data for both formulations.

During the review, the SEC noted that Delafloxacin is a broad-spectrum fluoroquinolone antibiotic, and emphasised that its clinical use must be restricted to severe ABSSSI cases involving Multi-Drug Resistant (MDR) organisms to ensure appropriate antibiotic stewardship. After evaluating the BE results and proposed protocol, the committee instructed Sun Pharma to amend the design before further regulatory consideration.

The committee laid down the following compulsory modifications to the Phase-III protocol:

1. Patients with severe ABSSSI with risk factors for the MDR organism to be included.

2. In the comparator arm drug Meropenam should be used instead of Aztreonam.

3. Only MRSA culture positive patients should be included in the study. Till the receipt of culture result, the patient must be treated with standard of care treatment.

4. Subject monitoring should include QT prolongation and neuropathy assessment.

Delafloxacin, internationally known for its activity against MRSA and gram-negative organisms, is marketed in several countries for ABSSSI management. Sun Pharma seeks to introduce both tablet and injectable forms in the Indian market.

The SEC instructed that the revised Phase-III protocol must be resubmitted to CDSCO for further scientific and regulatory review before trial approval is considered.