Modify Phase III CT protocol: CDSCO panel Tells Windlas Biotech on FDC Tamsulosin plus Mirabegron
New Delhi: Responding to the revised Phase III clinical trial protocol of fixed dose combination (FDC) Tamsulosin plus MirabegronIP 0.4 mg/0.4 mg + Mirabegron (ER) 25 mg/50 mg tablets, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined Windlas Biotech to modify the Phase III clinical trial protocol in line with the inclusion criteria, scientific methodology explanation, and scientific terminology.
This came after the firm presented the proposal along with the revised Phase III clinical trial protocol before the committee.
The combination of tamsulosin and mirabegron is used to treat overactive bladder (OAB) symptoms, especially in men with benign prostatic hyperplasia (BPH) who are also experiencing lower urinary tract symptoms (LUTS).
Tamsulosin is in a class of medications called alpha blockers. It works by relaxing the muscles in the prostate and bladder so that urine can flow easily. Tamsulosin is a selective alpha1A-adrenergic receptor antagonist. The effects of tamsulosin are targeted for the smooth muscle receptors of the prostate and urethra. Blocking this receptor relaxes the smooth muscle of the bladder and urethra to improve urine flow.
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).
Mirabegron is in a class of medications called beta-3 adrenergic agonists. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination.
Mirabegron is used alone or together with other medicines to treat the symptoms of an overactive bladder (OAB), such as incontinence (loss of bladder control), a strong need to urinate right away, or a frequent need to urinate.
At the recent SEC meeting for urology held on February 18, 2025, the expert panel reviewed the revised Phase III clinical trial protocol presented by Windlas Biotech.
After detailed deliberation, the committee opined that the following modifications are required in the Phase III CT Protocol:
1. Point numbers 1, 2, and 3 in the inclusion criteria need to be elaborated to define which type of patients should be enrolled in the study.
2. Scientific methodology needs to be explained in detail and assessment parameters need to be mentioned clearly.
3. Scientific terminology should be used in the Phase III CT protocol.
Accordingly, the expert panel suggested that the firm should submit a revised Phase III clinical trial protocol to CDSCO for further review by the committee.
