Conduct phase III clinical study on resistant hypertension: CDSCO Panel tells Sun Pharmaceutical Industries on Esaxerenone
New Delhi: Responding to the proposal presented by the drug major Sun Pharmaceutical Industries to manufacture and market the drug Esaxerenone tablets 2.5 mg and 5 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct a phase III clinical study on resistant hypertension.
This came after Sun Pharmaceutical Industries presented the proposal to manufacturer and market Esaxerenone tablets along with a request for grant of permission to conduct a phase III clinical trial and deliberations of comparative bioavailability before the committee.
Esaxerenone is a nonsteroidal mineralocorticoid receptor antagonist (MRA) used to treat hypertension and diabetic nephropathies.
Esaxerenone is a selective, potent, and long-lasting nonsteroidal mineralocorticoid receptor antagonist developed on the basis of dihydropyridine calcium channel blockers such as felodipine and nimodipine, which have mineralocorticoid receptor blocking properties.
The committee deliberated in detail that esaxerenone tablets (2.5 mg and 5 mg) are not indicated for essential hypertension as per the guidelines.
The committee noted that another applicant has been recommended for grant of permission to conduct a Phase III clinical trial of the same drug with the indication of resistance hypertension.
In line with the above, the committee reviewed and requested the firm that the BE study conducted for export purposes be submitted along with the bioequivalence (BE) study protocol for further review.
In addition to the above, regarding the phase III protocol presented by the firm on essential hypertension, which was reviewed by the committee, the expert panel opined that the firm needs to conduct a phase III clinical study on resistant hypertension and submit the protocol accordingly to the committee.
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