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 with erectile dysfunction and benign prostatic hyperplasia (BPH), begin the initial clinical trial.
The company reported in March that its generic version was in the final stages of preclinical testing as a potential first-line treatment for these two conditions.
Development and testing efforts have resulted in a formulation and manufacturing process that is considered equivalent to the brand reference product, Cialis, in terms of its key quality physical and chemical attributes. The generic drug also has similar drug release characteristics which are indicative of comparable in vivo performance.
Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor that works by relaxing muscles in the walls of blood vessels to increase blood flow.
“BioPharmcor is ready to go on to manufacture lots of clinical trials and clinical trials in healthy volunteers to demonstrate bioequivalence. Once the clinical trial material is available, the studies will take approximately six months to complete and then there will be an additional period of nine months for the generation of stability data (12 months of data in total) for regulatory presentations that will occur in parallel, “a spokesman for VMS Rehab Systems said in a press release.
If bioequivalence and the use of generic tadalafil approved by regulatory agencies are established, BioPharmcor, which is based in the Netherlands, plans to market the drug initially in the European Union and parts of North America as an alternative Safe, to Cialis, which is produced by Lilly.
In 2015, an article published in the Arab Journal of Urology entitled “Inhibitors of phosphodiesterase type 5 to treat erectile dysfunction and lower urinary tract symptoms secondary to benign prostatic hyperplasia: a comprehensive review”, reviewed the evidence More recent on the potential Adequacy of PDE5 inhibitors for the treatment of ED and BPH.
Its lead author, Dr. Albert Haddad, along with Dr. Michel Jabbour and Dr. Muhammad Bulbul, demonstrated that, in light of the strong connection between erectile dysfunction and BPH, clinicians should consider the benefits of treating Both conditions using PDE5 inhibitors, such as Cialis.