Wockhardt secures CDSCO panel conditional nod to conduct Phase IV Trial of Levonadifloxacin

After detailed deliberation the committee recommended for grant of permission to conduct Phase IV Clinical Trial of Levonadifloxacin for both Intravenous and Oral formulations subject to the following conditions:

1. The study should be conducted with only oral formulation.

2. The patients with ABSSI not requiring surgery should be included.

3. Patients taking other antibiotics should not be included in the study.

4. The QTc interval mentioned in the exclusion criteria should be revised from more than 470 mSec to more than 450 mSec.

5. Smokers and alcoholic patients should be excluded from the protocol.

6. The study drug and the rescue antibiotics should be used based on the culture sensitivity data.

SEC also recommended that for Phase IV Clinical trial of Intravenous formulation, the firm should submit separate protocol as per the condition of manufacturing permission.

Last year, in first global approval, Wockhardt got approval from the Indian drug regulator for 2 new antibiotics, EMROK (IV) and EMROK O (Oral), for acute bacterial skin and skin structure Infections including diabetic foot infections and concurrent bacteraemia based on the Phase 3 study involving 500 patients in 40 centers across India.

Read also: Setback To Bharat Biotech: CDSCO Panel Rejects To Approve Covaxin, Seeks More Data