CDSCO Panel Rejects Dr. Reddy's Proposal For Ketorolac Tromethamine plus Serratiopeptidase FDC

This came after the drug major Dr. Reddy's Laboratories presented the proposal before the committee along with a request for bioequivalence (BE) study waiver and Phase III clinical trial study protocol of the fixed-dose combination (FDC) Tromethamine 10mg plus Serratiopeptidase (DR)15mg Capsules.

Ketorolac is used to relieve moderately severe pain, usually pain that occurs after an operation or other painful procedure. It belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

Ketorolac inhibits key pathways in prostaglandin synthesis which is crucial to its mechanism of action. Although ketorolac is non-selective and inhibits both COX-1 and COX-2 enzymes, its clinical efficacy is derived from its COX-2 inhibition.

Serrapeptase is a “super enzyme” and has been used in general surgery, orthopaedics, dentistry, and gynecology, among other practices and procedures. It is used because of its analgesic and anti-inflammatory properties.

The enzyme has its mode of action on the arachidonic acid pathway (COX I and COX II), and acts on the cyclooxygenase pathway, but not on the lipooxygenase pathway (LOX).

At the recent SEC meeting for Analgesic and Rheumatology held on 27th July 2023, the expert panel reviewed the proposal presented by Dr. Reddy's Laboratories for bioequivalence (BE) study waiver and Phase III clinical trial study of the fixed-dose combination (FDC) Tromethamine 10mg plus Serratiopeptidase (DR)15mg Capsules.

The committee noted that:

1. The proposed FDC is not approved anywhere in the world.

2. The PK is not matching with the FDC as Ketorolac Tromethamine should be taken post-meal and Serratiopeptidase should be taken before meal.

3. There is no additional benefit of Serratiopeptidase in the FDC as the proposed duration of treatment is short for 3 to 5 days only.

4. There is no rationality for the FDC.

5. Serratiopeptidase is withdrawn from the market by the innovator company voluntarily in Japan due to efficacy issues.

6. Serratiopeptidase is not approved as a drug in any ICH countries as informed by the firm.

After detailed deliberation, the committee did not recommend approval of the FDC.

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