This came in wake of proposal presented by the drug major Cipla to manufacture and market Rizatriptan Benzoate Orally Disintegrating Tablets 5mg along with bioequivalence (BE) study protocol.
Bioequivalence studies are special type of studies where two drugs or two sets of formulation of the same drug are compared to show that they have nearly equal bioavailability and pharmacokinetic/pharmacodynamic (PK/PD) parameters. The purpose of bioequivalence (BE) studies is to identify pharmaceutical equivalents or alternatives to be used interchangeably for the same therapeutic effect as a previously marketed drug.
Rizatriptan is a selective serotonin receptor agonist, which works by narrowing the blood vessels in the brain, stopping pain signals from being sent to the brain, and preventing the release of certain natural substances that cause pain, nausea, and other symptoms of migraine.
Rizatriptan is used to treat acute migraine headaches in adults and children 6 years of age and older. 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. It is usually taken at the first sign of a migraine headache. It induces vasoconstriction, by inhibiting the release of calcitonin gene-related peptide from sensory neurons in the trigeminal nerve. Rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established.
At the recent SEC meeting for Neurology and Psychiatry held on 21.07.2022,the expert panel reviewed proposal presented by the firm Cipla to manufacture and market Rizatriptan Benzoate Orally Disintegrating Tablets 5mg along with BE study protocol.
After detailed deliberation, the committee recommended for grant of permission to conduct the BE study
However the committee recommended to reduce sampling time points and blood volume during the study. Further, the expert panel directed that the firm should submit the revised protocol to CDSCO.
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