Revise Phase III CT Protocol:  CDSCO Panel Tells Windlass Biotech on FDC Tamsulosin Hydrochloride plus Mirabegron

New Delhi: In response to the proposal presented by the drug maker Windlass Biotech, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the firm revise the Phase III clinical trial protocol of the fixed-dose combination (FDC) Tamsulosin Hydrochloride IP (MR) 0.4 mg/0.4 mg plus Mirabegron (ER) 25 mg/50 mg tablets.

This came after the firm presented the proposal along with a bioequivalence (BE) study report and Phase III clinical trial study protocol before the committee.

The expert panel stated that the protocol is not scientifically justified and needs to be revised for better justification. Furthermore, the expert panel added that BPH patient inclusion criteria should be revised for their confirmed diagnosis and the firm should change the comparator arm.

Tamsulosin is used to treat men who have symptoms of an enlarged prostate gland, which is also known as benign enlargement of the prostate (benign prostatic hyperplasia or BPH). Benign enlargement of the prostate is a problem that can occur in men as they get older. The prostate gland is located below the bladder.

Mirabegron, a beta-3 adrenoceptor agonist, has been shown to have a high safety and efficacy profile in large random placebo-controlled clinical trials. Mirabegron is used to treat urgency, urge urinary incontinence, and increased urinary frequency found in the overactive bladder.

At the recent SEC meeting for Urology held on 25th July 2024, the expert panel reviewed the proposal along with a BE study report and Phase III CT study protocol of the Tamsulosin Hydrochloride plus Mirabegron tablets presented by drug major Windlass Biotech.

After detailed deliberation, the committee considered a BE study report. As regards the Phase III clinical trial protocol, the committee opined that:

1. The protocol is not scientifically justified and needs to be revised for better justification.

2. BPH patient inclusion criteria should be revised for their confirmed diagnosis.

3. The firm should change the comparator arm.

Accordingly, a revised Phase III clinical trial protocol should be submitted to CDSCO for further review by the committee.

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