Modify Phase IV CT protocol: CDSCO Panel Tells Alkem on Amoxicillin, Clavulanate Oral Suspension

Written by Dr. Divya Colin Published On 2023-12-20T18:56:54+05:30 | Updated On 20 Dec 2023 10:08 PM IST

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Alkem Pharmaceutical to modify the Phase IV clinical trial protocol of the fixed-dose combination (FDC) drug Amoxicillin plus Clavulanate Potassium oral suspension in accordance with the Inclusion criteria, dose of the Potassium Clavulanate, sites of study.

This came after the firm presented the Phase IV clinical trial protocol before the committee, in light of the condition mentioned in permission in Form CT-23 dated 10.09.2021.

In line with the inclusion criteria, the expert panel suggested that inclusion criteria should be changed for Community-acquired bacterial pneumonia to include microbiology confirmatory tests.

Furthermore, the committee stated that participants should be enrolled in thousands, and North Indian sites should be included to represent pan-Indian representation.

In addition, the committee noted that the dose of Potassium Clavulanate should be corrected.

Amoxicillin/clavulanic acid is a combination of penicillin-type antibiotics used to treat a wide variety of bacterial infections. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections.

Amoxicillin belongs to the group of medicines known as penicillin antibiotics. Amoxicillin competitively inhibits penicillin-binding protein 1 and other high molecular weight penicillin-binding proteins. Penicillin-binding proteins are responsible for glycosyltransferase and transpeptidase reactions that lead to cross-linking of D-alanine and D-aspartic acid in bacterial cell walls. Without the action of penicillin-binding proteins, bacteria upregulate autolytic enzymes and are unable to build and repair the cell wall, leading to bacteriocidal action.

It is used to treat bacterial infections, such as chest infections (including pneumonia) and dental abscesses. It can also be used together with other antibiotics and medicines to treat stomach ulcers. It's often prescribed for children, to treat ear infections and chest infections.

Clavulanate potassium (the potassium salt of clavulanic acid) is a β-lactamase inhibitor that is added to amoxicillin to prevent inactivation by bacterial enzymes. β-Lactamase inhibitors (clavulanate, sulbactam, tazobactam) irreversibly bind to β-lactamase.

At the recent SEC meeting for Antimicrobial and Antiviral held on 29th November 2023, the expert panel reviewed the Phase IV clinical trial protocol of FDC Amoxicillin plus Clavulanate Potassium Oral Suspension.

After detailed deliberation, the committee recommended the following modification in the Phase IV clinical trial Protocol:
1. As it is presented as a phase IV clinical study, participants should be enrolled in thousands.
2. Inclusion criteria should be changed for Community-acquired bacterial pneumonia to include microbiology confirmatory tests.
3. Dose of the Potassium Clavulanate should be corrected.
4. North Indian sites should be included to represent pan-Indian representation.

Also Read: Conduct Phase III CT: CDSCO Panel Tells Akum Pharmaceutical on Antidiabetic FDC

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.