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