Alkem Laboratories Gets CDSCO Panel Nod to Study Amoxicillin,Clavulanate Powder for reconstitution into suspension

New Delhi: Reviewing the revised Phase IV clinical trial (CT) protocol of antimicrobial drug Amoxicillin Trihydrate plus Potassium Clavulanate powder for reconstitution into suspension presented by the drug major Alkem Laboratories, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct the Phase IV CT of the proposed FDC.

This came after the drug major Alkem Laboratories presented the revised Phase-IV CT protocol before the committee. Phase-IV CT is a type of clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market.

Amoxicillin trihydrate is a hydrate that is the trihydrate form of amoxicillin; a semisynthetic antibiotic used either alone or in combination with potassium clavulanate.

Amoxicillin trihydrate treats bacterial infections like 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.

Amoxicillin is a penicillin derivative used for the treatment of infections caused by gram-positive bacteria, in particular streptococcal bacteria causing upper respiratory tract infections. 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.

Clavulanic acid is a medication that can be used in conjunction with amoxicillin to manage and treat bacterial infections, specifically bacteria that are beta-lactamase producers. It is in the beta-lactamase inhibitor class of medications.

Potassium Clavulanate is used in the treatment of bacterial infections. Potassium Clavulanate is a beta-lactamase inhibitor. It works by blocking an enzyme (beta-lactamase) produced by bacteria to inactivate antibiotics. This reduces resistance and enhances the activity of antibiotics against bacteria.

At the recent SEC meeting for Antimicrobial and Antiviral held on 10th April 2024, the expert panel reviewed the revised Phase IV CT protocol of the FDC Amoxicillin Trihydrate plus Potassium Clavulanate powder for reconstitution into suspension.

After detailed deliberation, the committee recommended the grant of permission to conduct the Phase-IV CT as per the presented protocol.

Accordingly, the expert panel suggested that the firm should submit a Phase-IV CT report for further review by the committee.

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