CDSCO Panel Rejects Dr Reddy's Proposal to Study FDC of Ketorolac plus Serratiopeptidase Capsules
New Delhi: Citing there is no rationality of the combination and significant benefits, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has rejected the drug major Dr. Reddys Laboratories' proposal to conduct a clinical trial of fixed-dose combination (FDC) Ketorolac Tromethamine 10mg plus Serratiopeptidase 15mg Capsules.
This came after the drug major Dr. Reddys Laboratories presented the medical rationale/justification along with the Phase III clinical trial study protocol and request for bioequivalence (BE) study waiver before the committee.
Ketorolac is a medication used in the management and treatment of acute moderate to severe pain. It is in the nonsteroidal anti-inflammatory drug class.
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).
Serratiopeptidase belongs to the class of drugs known as 'non-steroidal anti-inflammatory drugs' (NSAID). Serratiopeptidase is used in oral surgery for its anti-inflammatory purpose after impaction surgery, maxillofacial trauma, and infections but its use should be limited in cases of abscess due to its fibrinolytic activity.
Ketorolac Tromethamine plus Serratiopeptidase can help relieve pain in conditions like rheumatoid arthritis and osteoarthritis. Along with painkillers, this medicine also contains an active ingredient called Serratiopeptidase, which is an enzyme that promotes the overall healing process and speeds up recovery.
At the recent SEC meeting for Analgesic and Rheumatology held on 6th February 2024, the expert panel reviewed the medical rationale/justification along with the Phase III clinical trial study protocol and request for BE study waiver for the FDC Ketorolac Tromethamine plus Serratiopeptidase Capsules.
The committee noted that:
1. The firm did not present the rationality of the combination and its significant benefits.
2. The proposed FDC is not approved anywhere in the world.
3. The PK does not match with the FDC as Ketorolac Tromethamine should be taken post-meal and Serratiopeptidase should be taken before the meal.
4. There is no additional benefit of Serratiopeptidase in the FDC as the proposed duration of treatment is short for 3 to 5 days only.
5. In the proposed CT protocol, the firm has used a single drug Ketorolac as the comparator product with the non-inferior study design.
After detailed deliberation, the committee did not recommend approval of the FDC.
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