Akums Gets CDSCO Panel Nod for BE Study of Rizatriptan-Meloxicam FDC, Told to Revise Phase III Protocol
New Delhi: In response to the proposal presented by the Akums Drugs & Pharmaceuticals along with BE and Phase III clinical trial protocol of the fixed dose combination (FDC) Rizatriptan Benzoate plus Meloxicam IP 20mg uncoated orally disintegrating Tablet, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended for grant of permission to conduct the BE study of the proposed drug.
In addition, the committee opined that placebo should not be used as a comparator and patient with frequency of migraine attack more than 2 in a month should be included in inclusion criteria and above mentioned criteria for 6 months prior to starting study and patients on Prophylaxis medication should not be included in the study and same may be mentioned in the exclusion criteria.
Also, the committee recommended the firm to submit BE study report along with revised Phase III clinical trial protocol to CDSCO for further review by the committee.
This came after the firm presented the proposal along with BE & Phase III clinical trial protocol before the committee.
Meloxicam and rizatriptan combination 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. Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID).
Rizatriptan is used to treat migraine headaches (severe, throbbing headaches that sometimes cause nausea and sensitivity to sound and light). Rizatriptan is in a class of medications called selective serotonin receptor agonists.
Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve the symptoms of arthritis (juvenile rheumatoid arthritis, osteoarthritis, and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain.
At the recent SEC meeting for Neurology and Psychiatry held on 18th June 2025, the expert panel reviewed the proposal along with BE & Phase III clinical trial protocol before the committee.
After detailed deliberation, the committee recommended for grant of permission to conduct the BE study.
As regard to Phase III clinical trial protocol, the committee opined that:
1. Placebo should not be used as a comparator.
2. Patient with frequency of migraine attack more than 2 in a month should be included in inclusion criteria and above mentioned criteria for 6 months prior to starting study.
3. Patients on Prophylaxis medication should not be included in the study and same may be mentioned in the exclusion criteria.
"Accordingly, the firm should submit BE study report along with revised Phase III clinical trial protocol to CDSCO for further review by the committee," the panel noted.
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