VMS Rehab Systems announced that its generic drug unit, BioPharmcor BV, has made significant progress in its formulation program to develop a generic version of Cialis (tadalafil), a treatment for patients of erectile dysfunction and benign prostate hyperplasia (BPH), and soon planned to begin initial clinical testing.
The company reported in March that its generic version was in the final preclinical testing stages as a potential first-line treatment for these two conditions.
Development and testing efforts have produced a formulation and manufacturing process that is considered equivalent to the branded reference product, Cialis, in terms of both its key quality physical and chemical attributes. The generic drug also has similar drug-release characteristics that are indicative of comparable in vivo performance.
Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor that works by relaxing the muscles in the walls of blood vessels to increase blood flow.
“BioPharmcor is ready to move into clinical trial batch manufacture and clinical studies in healthy volunteers to demonstrate bioequivalence. Once clinical trial material is available, the studies will take approximately six months to complete and then there will be a further 9 month period for the generation of stability data (12 months data in total) for the regulatory submissions that will happen in parallel,” said a VMS Rehab Systems’ spokesperson in a press release.
Should bioequivalence be established and the use of generic tadalafil approved by regulatory agencies, BioPharmcor, which is based in the Netherlands, plans to market the drug initially within the European Union and in parts of North America as a safe, effective and lower-cost alternative to Cialis, which is produced by Lilly.
In 2015, an article published in the Arab Journal of Urology, titled “Phosphodiesterase type 5 inhibitors for treating erectile dysfunction and lower urinary tract symptoms secondary to benign prostatic hyperplasia: A comprehensive review,” reviewed the most recent evidence at the time on the potential adequacy of PDE5 inhibitors for the treatment of ED and BPH.
Its lead author, Dr. Albert Haddad, together with Dr. Michel Jabbour and Dr. Muhammad Bulbul, showed that, in light of the strong connection between erectile dysfunction and BPH, physicians should consider the benefits of treating both conditions by using PDE5 inhibitors, such as Cialis.