Conduct bioequivalence study: CDSCO Panel Tells Cipla on Arsenic Trioxide Oral Solution
New Delhi: In response to a proposal presented by drug major Cipla for manufacturing and marketing of the chemotherapeutic agent Arsenic Trioxide Oral Solution, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to conduct bioequivalence (BE) study and submit the report.
This came after the drug major Cipla presented its proposal for the manufacture and marketing of Arsenic Trioxide Oral Solution 1mg/ml-5ml (additional dosage form and Indication) along with therapeutic rationale and justification for Phase III clinical trial waiver and BE study protocol before the committee.
Arsenic trioxide is a chemotherapeutic agent used in the treatment of refractory or relapsed acute promyelocytic leukaemia in patients with prior retinoid and anthracycline chemotherapy.
Arsenic trioxide is a chemotherapeutic agent of idiopathic function used to treat leukemia that is unresponsive to first-line agents. It is suspected that arsenic trisulfide induces cancer cells to undergo apoptosis. In general, arsenic is known to be a naturally toxic substance capable of eliciting a variety of dangerous adverse effects. The enzyme thioredoxin reductase has recently been identified as a target for arsenic trioxide.
Arsenic Trioxide is indicated for induction of remission and consolidation in patients with acute promyelocytic leukaemia (APL) who are refractory to or have relapsed from retinoid and anthracycline chemotherapy.
Arsenic trioxide causes morphological changes and DNA fragmentation characteristic of apoptosis in NB4 human promyelocytic leukemia cells in vitro. Arsenic trioxide also causes damage or degradation of the fusion protein PML/RAR-alpha. It is suspected that arsenic trioxide induces cancer cells to undergo apoptosis.
At the recent SEC meeting for Oncology and Hematology held on 25th July 2023, the expert panel reviewed the proposal for the manufacturer and market of Arsenic Trioxide Oral Solution 1mg/ml-5ml along with therapeutic rationale and justification for Phase III clinical trial waiver and BE study protocol before the committee.
The Committee noted that the product Arsenol (arsenic trioxide) solution for oral use is only 5mg in 5ml (1mg/ml) with the same indication being approved since 2008 in the Hongkong.
After detailed deliberation, the Committee recommended conducting BE study as per the protocol presented and the firm should submit BE study report for further consideration of Phase III clinical trial waiver.
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