VMS Rehab Systems recently announced that its research center, BioPharmcor BV, has made significant progress towards its formulation program in being able to develop a generic version of Cialis (tadalafil). This new medication aimed at treating patients with ED and benign prostatic hyperplasia (BPH) has entered the final clinical trials phase.
In March, BioPharmcor BV reported that its generic version of Cialis was in the final stages of preclinical testing to be eventually used as a potential first-line treatment for erectile disorders.
Research and testing of the new formulation and manufacturing processes suggest that this generic is equivalent to the name-brand product Cialis with respect to critical physical and chemical attributes. The generic drug has also demonstrated similar characteristics comparable to in vivo performance of Cialis.
Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor aimed at relaxing muscles in the penis leading to increased blood flow.
“BioPharmcor is ready to start clinical trials in patients as well as in healthy volunteers to demonstrate bioequivalence to Cialis. Once clinical trial data become available, the remaining open studies are expected to close within the next six months. There will then be a waiting period of nine months to collect stability data (12 months of data in total) for regulatory presentations“ – stated in a press release by a spokesperson for VMS Rehab Systems.
If regulatory agencies approve the use of generic Tadalafil, BioPharmcor, which is based in the Netherlands, plans to initially market the drug in the European Union and parts of North America as a safe alternative to Cialis (Lilly Pharmaceuticals).
In 2015, the Arab Journal of Urology published an article entitled, “Inhibitors of Phosphodiesterase Type 5 to Treat Erectile Dysfunction and Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: a Comprehensive Review.” This article provided a reviewed the evidence from recent studies on the potential use of PDE5 inhibitors for the treatment of ED and BPH.
The lead author of this review, Dr. Albert Haddad, along with Dr. Michel Jabbour and Dr. Muhammad Bulbul, suggest that in light of the strong connection between ED and BPH, health care providers should consider treating both conditions with PDE5 inhibitors, such as Cialis.