Glenmark Gets CDSCO panel nod for Phase IV CT of Fosnetupitant, Palanosetron FDC drug

Published On 2023-02-05 11:30 GMT | Update On 2023-02-05 11:30 GMT

New Delhi: Pharmaceutical major Glenmark Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct the Phase IV clinical trial for the fixed-dose combination drug Fosnetupitant 235 mg and Palanosetron 0.25mg used as a prophylactic regimen to prevent vomiting after the chemotherapy.

This came after the firm presented the Phase IV clinical trial protocol (Protocol No.GPL/CT/2022/008/IV, version: 2.0 dated 07-Dec-2022 before the committee.

Fosnetupitant is a medication used in combination with others to prevent chemotherapy-associated nausea and vomiting. Fosnetupitant competitively binds to and blocks the activity of the human substance P/NK1 receptors in the central nervous system (CNS), inhibiting NK1-receptor binding of the endogenous tachykinin neuropeptide substance P (SP), which results in the prevention of chemotherapy-induced nausea and vomiting (CINV).

Palonosetron injection is used to prevent nausea and vomiting that are caused by cancer medicines (chemotherapy). It is also used to prevent nausea and vomiting that may occur after surgery. Palonosetron competitively blocks the action of serotonin at 5-hydroxytryptamine type 3 (5-HT3) receptors located on vagal afferents in the chemoreceptor trigger zone (CTZ), resulting in suppression of chemotherapy-induced nausea and vomiting.

At the recent SEC meeting for Oncology and Hematology held on 19th January 2023, the expert panel reviewed the Phase IV clinical trial protocol of the drug Fosnetupitant 235 mg and Palanosetron 0.25mg (Concentrate for solution for infusion) presented by the drug major Glenmark Pharmaceutical.

After detailed deliberation, the committee recommended the grant of permission to conduct the Phase IV clinical trial as per the submitted protocol.

Also Read:Sanofi Gets CDSCO panel nod to market Olipudase alfa for rare disease

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Dr. Divya Colin

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.

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Glenmark Gets CDSCO panel nod for Phase IV CT of Fosnetupitant, Palanosetron FDC drug

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