Wockhardt secures CDSCO panel conditional nod to conduct Phase IV Trial of Levonadifloxacin
New Delhi: Pharmaceutical and biotechnology major Wockhardt Ltd. has recently secured permission from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase IV Clinical Trial of Levonadifloxacin (both oral and Intravenous formulations).However, the expert panel has set some conditions, wherein, patients taking other antibiotics,...
New Delhi: Pharmaceutical and biotechnology major Wockhardt Ltd. has recently secured permission from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase IV Clinical Trial of Levonadifloxacin (both oral and Intravenous formulations).
However, the expert panel has set some conditions, wherein, patients taking other antibiotics, alcohol, and smoke should be excluded from the study of Levonadifloxacin among others.
Levonadifloxacin is a novel broad-spectrum anti-MRSA agent. It belongs to the benzoquinolizine subclass of quinolone, formulated for intravenous and oral administration, respectively.
The firm presented its proposal to the CDSCO committee to conduct a Phase IV Clinical Trial of Levonadifloxacin for both Intravenous and Oral formulations before the committee.
The Subject Expert Committee (SEC) of CDSCO, while examining IND proposals, made in its meeting held in December 2020 through Webex (Video conference), made some recommendations regarding the proposals.
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.
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