Submit justification for dose assumption and animal toxicity data: CDSCO Panel Tells Lupin on Rizatriptan nasal spray
New Delhi: Regarding the proposed bioavailability study protocol for Rizatriptan nasal spray (2.5 mg/spray, 5 mg/spray, 7.5 mg/spray), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Lupin to submit more elaborated justification for dose assumption and animal toxicity data generated on sufficient number of experimental animals.
This came after the drug maker Lupin presented the protocol no. LBC-P-039-24 Version no.00 Dt 15-4-2024 for bioavailability study for export purposes only.
Rizatriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels in the brain, stopping pain signals from being sent to the brain, and blocking the release of certain natural substances that cause pain, nausea, and other symptoms of migraine Rizatriptan is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound and light).
At the recent SEC meeting for neurology and psychiatry held on 12th December 2024, the expert panel reviewed the protocol no. LBC-P-039-24 Version no.00 Dt 15-4-2024 for bioavailability study for export purposes only.
After detailed deliberation, the committee opined that the firm is required to submit the following documents:
(1) More elaborated justification for dose assumption
(2) Animal toxicity data generated on a sufficient number of experimental animals, as the submitted toxicity data had a very less sample size.
Accordingly, the expert panel suggested that the firm submit the above information and data for re-deliberation in the SEC.
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