CDSCO Panel Asks Wockhardt to Revise Phase III Study Protocol for Nafithromycin, Seeks Dosing, Control Arm Changes

New Delhi: The Subject Expert Committee (SEC), which functions under the Central Drugs Standard Control Organisation (CDSCO), has recommended Wockhardt revise the Phase III study of Nafithromycin 400 mg Tablet.

This came after the firm presented the proposal for grant of permission to conduct Phase III study vide protocol no. W-4873-302, version 1.0, dated 23.04.2025, for the indication Acute Bacterial Rhinosinusitis (ARBS) before the committee.

Acute bacterial rhinosinusitis (ABRS) is a bacterial infection of the nasal passages and sinuses, often following a viral infection, that causes symptoms lasting more than 10 days or worsening after an initial improvement (double worsening).

Nafithromycin, was officially launched on November 20, 2024, by Union Minister Dr. Jitendra Singh. Developed by Wockhardt with support from the Biotechnology Industry Research Assistance Council (BIRAC), Nafithromycin, marketed as "Miqnaf," targets Community-Acquired Bacterial Pneumonia (CABP) caused by drug-resistant bacteria, which disproportionately affects vulnerable populations such as children, the elderly, and those with compromised immune systems.

The committee has noted that the drug is already approved in the country for the treatment of adults with community acquired bacterial pneumonia (CABP).

After detailed deliberation, the committee recommended the following changes in the presented protocol:

1. The Dose of Amoxicillin-Clavulanic acid 625 mg tablet orally in the control arm should be revised from twice daily to thrice daily as per IDSA and National guideline.

2. Protocol design should be revised to include administration of Azithromycin 500 mg OD tablet along with Amoxicillin-Clavulanic acid 625 mg tablet orally to all patients in the control arm.

3. Treatment should be started on the first visit of the patients.

4. Sample size should be inflated by 10% to account for loss to follow-up.