-Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company, announced today that the Company has dosed its first patient for its bioequivalence study of Tadalafil (Cialis®) and Finasteride (PROSCAR®) combination tablet for benign prostatic hyperplasia (BPH) (Tad-Fin Combination Tablet). Tad-Fin Combination Tablet is designed for the co-administration of tadalafil and finasteride to improve patient compliance and convenience for men suffering from BPH. Finasteride shrinks the prostate while tadalafil treats the symptoms of BPH.
The bioequivalence study will enroll 36 patients and will be completed in approximately four weeks. Clinical results will be reported in the first calendar quarter of 2019. In addition, the Company has initiated manufacturing of the commercial grade product through its contract manufacturer to be used for an NDA submission to the U.S. Food and Drug Administration (FDA). If successful, NDA submission target is mid-2019.
“The co-administration of tadalafil and finasteride has been clinically proven to significantly improve lower urinary tract symptoms in men with BPH and an enlarged prostate, all with attendant benefits for erectile dysfunction,” commented Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru.* “Co-administration reduces the risk of acute urinary retention and the potential need for surgery while shrinking prostate size. We believe our Tad-Fin Combination Tablet will provide convenience which should substantially increase compliance improving the health of patients.”
About Tadalafil/Finasteride Combination Tablet
Tad-Fin Combination Tablet is a new combination tablet containing 5 mg tadalafil and 5 mg finasteride to improve lower urinary tract symptoms in men with BPH and an enlarged prostate. Finasteride inhibits the enzyme 5-alpha-reductase, which converts testosterone to the more potent dihydrotestoserone. By doing so, it can act to shrink the prostate, prevent the progression of BPH, reduce the risk of acute urinary retention and reduce the potential need for surgery. Tadalafil is a PDE5 inhibitor that has efficacy in relieving the symptoms of BPH by relaxing the smooth muscle of the prostate and is also indicated for erectile dysfunction. Co-administration of tadalafil and finasteride is currently FDA approved for the initial treatment of symptoms of BPH for up to 26 weeks.