Cipla Secure CDSCO Panel Nod To Study Rizatriptan Benzoate Orally Disintegrating Tablet

Written by Dr. Divya Colin Published On 2022-08-03T18:00:14+05:30 | Updated On 3 Aug 2022 6:00 PM IST

Cipla Secure CDSCO Panel Nod To Study Rizatriptan Benzoate Orally Disintegrating Tablet

New Delhi: Granting approval to conduct bioequivalence (BE) study of Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has recommended the drug major Cipla to reduce sampling time points and blood volume during the study.

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.

Also Read:Zenara Pharma gets CDSCO nod to make generic version of Pfizer Covid pill

CiplaRizatriptan BenzoateMigrainebioequivalence studycdsco panel

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.