-- Combination Tablet Treats BPH Symptoms; Shrinks Prostate and Prevents BPH Progression --
-- NDA Submission Target Mid 2019 --
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
“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
About Tadalafil/Finasteride Combination Tablet
The Veru prostate cancer pipeline includes zuclomiphene citrate (also known as VERU-944, cis-clomiphene) and VERU-111 (bisindole). Zuclomiphene citrate is an estrogen receptor agonist being evaluated in a Phase 2 trial to treat hot flashes, a common side effect caused by hormone treatment for men with advanced prostate cancer. VERU-111 is an oral, next-generation, first-in-class small molecule that targets and binds to alpha and beta subunits of microtubules in cells to treat metastatic prostate cancer patients whose disease is resistant to both castration and novel androgen blocking agent (abiraterone or enzalutamide) therapies. Veru expects
Veru is also advancing four new drug formulations in its specialty pharmaceutical pipeline addressing unmet medical needs in urology. Tamsulosin DRS granules and Tamsulosin XR capsules are formulations of tamsulosin, the active ingredient in FLOMAX®, which
Veru’s currently marketed products are the PREBOOST® medicated individual wipe for the prevention of premature ejaculation and the FC2 Female Condom®. The Female Health Company Division markets the FC2 Female Condom® in the global public health sector to improve the lives, health and well-being of women around the world. To learn more please visit www.verupharma.com.
*Casabé A et al.
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Press Release Kari Sharp