CDSCO Panel Declines to Consider ACME Generics' Phase IV Trial Results for Liothyronine Tablets
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) has declined to consider the Phase IV clinical trial results submitted by ACME Generics for Liothyronine Tablets 5 mcg and 20 mcg, citing multiple deficiencies in the data presented.
This came after the firm presented the Phase IV clinical trial report (Protocol ID: IBPL/ CT / PHASE-IV / 03 / 2022 – AG, Protocol Version 2.0; Date: 20October-2022) of the drug Liothyronine 5 mcg and 20 mcg tablets.
Liothyronine is a thyroid hormone replacement therapy used to treat hypothyroidism, to suppress TSH, and to help in the diagnosis of hyperthyroidism.
Liothyronine replaces endogenous thyroid hormone and then exerts its physiologic effects by controlling DNA transcription and protein synthesis. This effect on DNA is obtained by the binding of liothyronine to the thyroid receptors attached to DNA. Exogenous liothyronine exerts all the normal effects of the endogenous thyroid T3 hormone. Hence, it increases energy expenditure, accelerates the rate of cellular oxidation stimulating growth, maturation, and metabolism of the body tissues, aids in myelination of nerves and development of synaptic processes in the nervous system and enhances carbohydrate and protein metabolism.
Upon review, the committee observed that the firm did not present exact statistics of the data in the form of tables and graphs in order for the experts to evaluate the same.
Further, it was noticed that the clinical trial (CT) sites had unequal distribution of patients and a GCP audit is recommended.
The committee raised concerns about the capturing of adverse events and noted that commonly suspected adverse events have not been reported.
In view of these shortcomings, the committee did not consider the Phase IV CT results presented by the firm and recommended the firm present a well-structured and detailed presentation for further review by the committee.
