Exclude patients with significant cardiovascular diseases: CDSCO panel tells Hetero Labs on Polmacoxib, Paracetamol FDC
New Delhi: With the condition to exclude patients with significant cardiovascular diseases from the trial, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to Hetero Lab for conducting a bioequivalence study and clinical trial of the fixed-dose combination (FDC) drug Polmacoxib 2mg plus Paracetamol 325mg tablets.
However, the nod is subject to the condition that the firm needs to include screening tools to exclude patients with significant cardiovascular diseases.
This came after the firm presented the proposal along with BE Study and Phase-III clinical trial protocol of the FDC drug Polmacoxib 2mg plus Paracetamol 325mg tablets before the committee.
Polmacoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat osteoarthritis.
Paracetamol is a commonly used medicine that can help treat pain and reduce a high temperature (fever). It's typically used to relieve mild or moderate pain, such as headaches, toothache, or sprains, and reduce fevers caused by illnesses such as colds and flu.
Paracetamol has a central analgesic effect that is mediated through the activation of descending serotonergic pathways. Paracetamol belongs to the classes of analgesic and antipyretic drugs, commonly known as pain reliever and fever reducer, respectively. It is a widely used medicine worldwide. Although paracetamol is very effective in controlling pain, the drug does not contain anti-inflammatory properties.
At the recent SEC meeting for Analgesic and Rheumatology held on 7th June 2023, the expert panel reviewed the proposal presented by Hetero Lab along with BE Study and Phase III clinical trial protocol of the FDC Polmacoxib 2mg plus Paracetamol 325mg tablets
After detailed deliberation, the committee recommended the grant of permission for the conduct of the BE Study and conduct that trial subject to the condition include the following screening tools that should be included to exclude patients with significant cardiovascular diseases:
1. History of angina
2. History of myocardial infarction or stroke or transient ischemic attack (TIA),
3. History of Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Grafting (CABG).
4. 4.12-lead resting ECG, BP measurement at 2 separate occasions 30 minutes apart, ankle-brachial blood pressure index, serum NT-pro-BNP level.
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