Akums gets CDSCO panel nod to manufacture, market FDC Alfuzosin HCL,Tadalafil film coated tablets

However, this recommendation is subject to the condition that the firm conduct the active post-marketing surveillance (PMS) study for secondary efficacy and tolerability, including erectile dysfunction (ED) parameters.

This came after the firm presented the Phase III clinical trial study report of the FDC Alfuzosin Hydrochloride IP (as Extended Release) 10 mg/10 mg plus Tadalafil IP 2.5 mg/5 mg film-coated tablets before the committee.

Alfuzosin is an alpha-1 adrenergic antagonist used in the symptomatic management of benign prostatic hypertrophy (BPH). Alfuzosin selectively binds to and inhibits alpha(1)-adrenergic receptors in the lower urinary tract. This leads to the relaxation of smooth muscle in both the prostate and bladder neck, resulting in an improvement in urine flow and a reduction of urinary symptoms.

Tadalafil is a phosphodiesterase-5 inhibitor used to treat erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension.

Tadalafil is indicated for the treatment of erectile dysfunction (ED) and either alone or in combination with finasteride for the treatment of benign prostatic hypertrophy (BPH). It is also indicated for the treatment of pulmonary arterial hypertension (PAH), both alone and in combination with macitentan or other endothelin-1 antagonists.

Tadalafil works to treat erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Tadalafil treats PAH by relaxing the blood vessels in the lungs to allow blood to flow more easily.

Combining both tadalafil and alfuzosin resulted in a greater relaxant effect. Likewise, the combination was more effective at reducing EFS (electrical field stimulation)-induced contractions compared with each compound alone.

At the recent SEC meeting for Reproductive & Urology held on February 28, 2023, the expert panel reviewed the Phase III clinical trial study report of the FDC Alfuzosin Hydrochloride IP (as Extended Release) 10 mg/10 mg plus Tadalafil IP 2.5 mg/5 mg film-coated tablets.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market the product with the condition of conducting the active PMS study for secondary efficacy and tolerability, including ED parameters.

In view of the above, the committee advised the firm that the active post-marketing surveillance (PMS) study protocol should be submitted to CDSCO within a month for review by the committee.