Reduce PSA level to less than 4 in inclusion criteria: CDSCO Panel Tells Akum Drugs and Pharmaceuticals on FDC Dutasteride plus Silodosin

New Delhi: Reviewing the active post-marketing surveillance (PMS) protocol of fixed-dose combination (FDC) Dutasteride plus Silodosin presented by Akums Drugs and Pharmaceuticals, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to modify inclusion criteria by reducing the Prostate-Specific Antigen (PSA) level to less than 4 and to include more geographically distributed sites.

In addition to the above, the expert panel suggested that PSA should be done at baseline and at the end of the study after 3 months. Furthermore, the committee advised to include more geographically distributed sites so that there should be 50% each from government and private sites.

This came after Akums Drugs and Pharmaceuticals presented the active post-marketing surveillance (PMS) protocol before the committee, in light of the condition mentioned in permission in Form CT-23 dated 09.12.2022.

Dutasteride is in a class of medications called 5-alpha reductase inhibitors. It works by blocking the production of a natural substance that enlarges the prostate. Dutasteride blocks the action of an enzyme called 5-alpha-reductase. This enzyme changes testosterone to another hormone that causes the prostate gland to grow. Dutasteride will cause the size of the prostate to decrease, but the effect lasts only as long as the medicine is taken.

Silodosin is in a class of medications called alpha-blockers. It relieves the symptoms of BPH by relaxing the muscles of the bladder and prostate. Silodosin is used to treat signs and 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.

At the recent SEC meeting for Urology held on 27th March 2024, the expert panel reviewed the active PMS protocol of the Dutasteride plus Silodosin (0.5mg/0.5mg + 4mg/8mg) uncoated bilayered tablet.

After detailed deliberation, the committee opined the following modification:

1. Inclusion criteria should be modified by reducing the PSA level to less than 4.

2. PSA should be done at baseline and at the end of the study after 3 months.

3. More sites to be included which should be geographically distributed so that there should be 50% each from Government and Private sites.

Accordingly, the expert panel stated that a revised Active PMS protocol should be submitted to CDSCO for further review by the committee.

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