Expert Panel Asks Ekam Pharma to Submit Global Prescribing Information Before Diazoxide 25 mg Clearance

New Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO) has opined that Ekam Pharma should submit the globally approved PI/ reference document for usage and method of administration of Diazoxide Capsule 25 mg in pediatric populations for the proposed indication to CDSCO for review by the Committee in the presence of a pediatrician.

This came after Ekam Pharma presented the proposal for the grant of permission for manufacturing and marketing Diazoxide capsules 25 mg, along with Justification for bioequivalence (BE) and a clinical trial waiver before the Committee.

Diazoxide is a non-diuretic benzothiadiazine derivative that activates ATP-sensitive potassium channels. It is chemically related to thiazide diuretics but does not inhibit carbonic anhydrase and does not have chloriuretic or natriuretic activity.

Diazoxide is commonly used in the treatment of hyperinsulinemic hypoglycemia due to its ability to inhibit insulin release. Diazoxide also exhibits hypotensive activity and reduces arteriolar smooth muscle and vascular resistance.

Diazoxide is a nondiuretic benzothiadiazine derivative used for the management of symptomatic hypoglycemia. By binding to the sulfonylurea receptor (SUR) subunit of the ATP-sensitive potassium channel (KATP) on the membrane of pancreatic beta‐cells, diazoxide promotes a potassium efflux from beta-cells. This hyperpolarizes the cell membrane and prevents the influx of calcium to the pancreatic beta‐cells. Without a sufficient amount of calcium in the cell, insulin release is inhibited.

Therefore, the use of diazoxide produces an increase in glucose levels. Diazoxide is chemically related to thiazide diuretics but does not inhibit carbonic anhydrase and does not have chloriuretic or natriuretic activity. It also exhibits hypotensive activity by reducing arteriolar smooth muscle and vascular resistance. The mechanism of action of its hypotensive effect has not been fully elucidated; however, it is possible that it involves the antagonism of calcium.

At the recent meeting, Ekam Pharma presented its justification for waiver of Bioequivalence and Clinical Trial requirements for Diazoxide Capsules 25 mg, citing existing data and prior approvals. The proposal was examined in detail by the committee.

After detailed deliberation, the committee opined that the firm should submit the globally approved PI/ reference document for usage and method of administration of Diazoxide Capsule 25 mg in pediatric populations for the proposed indication to CDSCO for review by the Committee in the presence of a pediatrician.