Submit PK-PD data of 3 cohorts for 7 days: CDSCO Panel Tells Shilpa Medicare on Ondansetron ER Inj Suspension IM study
New Delhi: Regarding the conduction of a study to evaluate the efficacy and safety of Ondansetron Extended-Release Injectable Suspension Intramuscular when compared to Ondansetron IM Injection for the prevention of chemotherapy-induced Nausea and Vomiting (CINV) in patients receiving moderate and highly emetogenic chemotherapy, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined Shilpa Medicare that the firm should submit pharmacokinetic and pharmacodynamic (PK-PD data) of 3 cohorts for 7 days, with a minimum effective concentration of the drug and QT interval data at Tmax.
This came after Shilpa Medicare presented the proposal for a grant of permission to conduct a Phase-III clinical trial titled “A Phase-III, Randomized, Multicentre, Double-Blind, Parallel Group, Prospective, NonInferiority Study to Evaluate the Efficacy and Safety of Ondansetron ExtendedRelease Injectable Suspension Intramuscular When Compared to Ondansetron IM Injection for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Moderately and Highly Emetogenic Chemotherapy” of the drug Ondansetron Extended-release (ER) intramuscular Injectable suspension 100mg/1ml along with Phase-III protocol (Protocol No. NV-05-1543-2023 Version No. 1.0 dated 29th Aug 2023) before the committee.
Ondansetron is in a class of medications called serotonin 5-HT3 receptor antagonists. It works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting
Ondansetron is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron is in a class of medications called serotonin 5-HT3 receptor antagonists. It works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting.
It is hypothesized that ondansetron blocks nausea and vomiting by 5-HT3 receptor antagonism at two specific sites: (i) centrally, in the area postrema/NTS; and (ii) peripherally on vagus nerve terminals. The absence of other pharmacological effects of ondansetron ensures an absence of side effects.
At the recent SEC meeting for Oncology and Hematology held on 21 and 22 December 2023, the expert panel reviewed the proposal to conduct a Phase-III clinical trial titled “A Phase-III, Randomized, Multicentre, Double-Blind, Parallel Group, Prospective, NonInferiority Study to Evaluate the Efficacy and Safety of Ondansetron ExtendedRelease Injectable Suspension Intramuscular When Compared to Ondansetron IM Injection for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Moderately and Highly Emetogenic Chemotherapy” presented by Shilpa Medicare.
In the above meeting, the firm informed that the Ondansetron extended-release (ER) intramuscular injectable suspension 100mg/1ml is not yet approved anywhere.
The committee noted that the justification submitted by the firm was not found scientifically adequate.
After detailed deliberation, the committee recommended that the firm submit PK-PD data of 3 cohorts for 7 days, with a minimum effective concentration of the drug and QT interval data at Tmax to CDSCO for further review by the committee.
