Submit rationality and desirability of Rizatriptan plus Naproxen: CDSCO Panel Tells Akum Drugs and Pharmaceutical

New Delhi: Noting that the firm did not present adequate justification/rationale for the proposed fixed-dose combination (FDC) of rizatriptan benzoate plus naproxen sodium USP (5mg + 550mg and 10mg + 550mg) film-coated tablets, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined to the drug maker Akums Drugs and Pharmaceuticals that more published scientific literature in peer-reviewed journals in support of the rationality and desirability of the proposed FDC should be submitted.

In addition, the expert panel stated that justification in light of standard therapeutic treatment guidelines should be presented and the firm should submit the international approval status of the proposed FDC.

This came after Akums Drugs and Pharmaceuticals presented the proposal along with the BE (bioequivalence) study protocol and Phase III clinical trial protocol before the committee.

Rizatriptan benzoate is a member of tryptamines. Rizatriptan benzoate is the benzoate salt form of rizatriptan, a member of the triptan class of agents with anti-migraine properties. Rizatriptan is used to treat acute migraine headaches with or without aura. It is not used to prevent migraine headaches and is not used for cluster headaches. Rizatriptan works in the brain to relieve the pain from migraine headaches.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve symptoms of arthritis (e.g., osteoarthritis, rheumatoid arthritis, or juvenile arthritis) such as inflammation, swelling, stiffness, and joint pain. Naproxen blocks arachidonate binding to competitively inhibit both cyclooxygenase (COX) isoenzymes, COX-1 and COX-2, resulting in analgesic and anti-inflammatory effects.

At the recent SEC meeting for neurology and psychiatry held on 19th March 2025, the expert panel reviewed the proposal along with the BE study protocol and Phase III clinical trial protocol.

After detailed deliberation, the committee opined the following:

1. The firm did not present adequate justification/rationale for the proposed FDC.

2. More published scientific literature in peer reviewed journal in support of rationality and desirability of proposed FDC should be submitted.

3. Justification in light of standard therapeutic treatment guidelines should be presented.

4. Firm should submit international approval status of proposed FDC.

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

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