Tadalafil Alongside Finasteride Once Daily Improved IPSS For Men


European Association of Urology CongressTadalafil, also known as Cialis, is making headlines in pharmaceutical news. A study released on March 18, 2013 touted the use of tadalafil alongside finasteride for sizably improving scores for men on the International Prostate Symptom Score. Marketed by Eli Lilly, the patent for Cialis expires on November 21, 2017. The study, which was revealed at the European Association of Urology Congress in Milan, showed that five milligrams of tadalafil {Cialis} administered alongside finasteride once daily significantly improved the scores for men on the International Prostate Symptom Score. These men had lower urinary tract symptoms of benign prostatic hyperplasia and enlarged prostates. Additionally, the co-administration of tadalafil and finasteride improved the erectile function scores in these men, who had both lower urinary tract symptoms of benign prostatic hyperplasia and erectile dysfunction at baseline. Both studies compared the once daily use of tadalafil and finasteride to finasteride and a placebo.

Currently approved by the FDA to treat the signs and symptoms of both benign prostatic hyperplasia and erectile dysfunction, tadalafil is proving to be successful. Finasteride is currently approved by the FDA for the treatment of men with benign prostatic hyperplasia with an enlarged prostate. The aforementioned study was comprehensive, and involved 696 men ages 45 and older. All of the men had an International Prostate Symptom Score of at least 13, a urine flow rate of 4 millimeters per second to 15 mL/sec and a prostate volume at least 30 mL. Results revealed that the primary endpoint was met regarding improved International Prostate Symptom Scores {IPSS}. The IPSS scores showed meaningful improvements through the 12 week study. The scores at 12 weeks significantly improved IPSS scores, specifically -5.2 for the tadalafil and finasteride group versus the placebo/finasteride at -3.8. The daily dose of tadalafil and finasteride also greatly improved the men’s IPSS total scores versus the placebo/finasteride at 4 weeks, specifically -3.9 versus -2.3. Finally, the 26 week mark also rendered a cogent result, with IPSS total scores of the tadalafil and finasteride treatment versus the placebo/finasteride being -5.5 versus -4.5.  With mild side effects such as headache, indigestion and back pain, results from this study appear to show the tadalafil and finasteride drug combination to be safe, efficacious and generally tolerable.

LGM Pharma provides TEVA API tadalafil, CAS number 171596-29-5, as well as finasteride, CAS number 98319-26-7 for research and development purposes. Clients can be assured of continuous support throughout the R&D process, as well as quality API products.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

  • Share: