Akums Drugs and Pharmaceuticals Limited on Thursday announced the launch of the Tamsulosin + Tadalafil Capsule therapy to the Indian market. According to a press statement, this innovative combined therapy, delivered in a fixed dose combination within a hard gelatin capsule, marks an important achievement for the company.
Notably, Akums has become the first Contract Development and Manufacturing Organization (CDMO) to obtain approval for the unique formulation of Tamsulosin 0.4/0.4mg + Tadalafil 2.5/5mg, as sanctioned by the Drug Controller General of India (DCGI).
“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. It is primarily used when an enlarged prostate impedes normal urine flow and bladder emptying,” the company said in a statement.
In tandem, the mechanism of action for Tadalafil centers on the inhibition of PDE5, a crucial enzyme located in the vascular smooth muscle cells of corpus cavernosum.
By impeding cGMP hydrolysis, Tadalafil promotes cGMP accumulation and the relaxation of vascular smooth muscle, facilitating the development of a physiologically-induced erection, contingent upon sexual stimulation, it added.
“The introduction of the Tamsulosin + Tadalafil Capsule underscores Akums’ commitment to advancing healthcare solutions for patients grappling with benign prostatic hyperplasia and erectile dysfunction. This innovative combination therapy not only offers a more convenient treatment option but also represents a significant leap forward in our pursuit of enhancing patient outcomes,” Sanjeev Jain, Jt. Managing Director, Akums Drugs & Pharmaceuticals Ltd., said in a statement.
Each hard gelatin capsule is composed of Tamsulosin Hydrochloride IP at 0.4/0.4mg (in its Extended-Release Form) and Tadalafil IP at 2.5/5mg (as a Film Coated Tablet).
Focusing on the urology segment, the Tamsulosin + Tadalafil Capsule boasts several key features. Demonstrating significant improvements in BPH and Erectile Dysfunction Index, the combination significantly improves Total, Voiding, and Storage IPSS (International Prostate Symptom Score), thereby offering a better efficacy on LUTS relief, it claimed.
