Submit Data on Paracetamol-Tapentadol Combination: CDSCO Panel tells MSN Laboratories

New Delhi: In response to the proposal presented by MSN Laboratories for the fixed-dose combination (FDC) drug Paracetamol plus Tapentadol Hydrochloride tablet, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to submit the literature demonstrating safety profile, adverse effect profile, drug abuse potential and international approval status.

This came after MSN Laboratories presented the proposal before the committee for the fixed-dose combination (FDC) drug Paracetamol IP 325mg plus Tapentadol Hydrochloride IP 50mg (as extended-release) tablet.

Tapentadol is an opioid used to manage severe pain that has not responded to non-opioid medications, and for which opioid analgesic therapy is appropriate. Tapentadol is a centrally-acting synthetic analgesic with a dual mechanism of action. It is a mu-opioid receptor agonist that also inhibits norepinephrine reuptake.

Tapentadol is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Due to the risks of addiction, drug abuse, and drug misuse, tapentadol is reserved for patients for whom alternative treatment options are unavailable

Paracetamol/acetaminophen is one of the most popular and most commonly used analgesic and antipyretic drugs around the world, available without a prescription, both in mono- and multi-component preparations.

It is recommended as a first-line treatment of pain associated with osteoarthritis. The mechanism of action is complex and includes the effects of both the peripheral (COX inhibition), and central (COX, serotonergic descending neuronal pathway, L-arginine/NO pathway, cannabinoid system) antinociception processes and "redox" mechanism.

Paracetamol is a well-tolerated drug and produces few side effects from the gastrointestinal tract, however, despite that, every year, has seen a steadily increasing number of registered cases of paracetamol-induced liver intoxication all over the world.

At the recent SEC meeting for Analgesic and Rheumatology held on 2nd May 2024, the expert panel reviewed the proposal presented by drug major MSN Laboratories for the fixed-dose combination (FDC) drug Paracetamol IP 325mg plus Tapentadol Hydrochloride IP 50mg (as extended-release) tablet.

After detailed deliberation, the committee opined that:

1. The firm should present Literature demonstrating a better safety profile and less chance of dependence on the proposed FDC.

2. The firm should present Literature demonstrating lesser adverse event/ side effect profile with the proposed FDC.

3. The firm should present more data on the drug abuse potential of Tapentadol.

4. The firm should present the International approval status of the proposed FDC.

Accordingly, the expert panel suggested that the firm should submit the above data to CDSCO for further review by the committee.