World News: 13:00 GMT Monday 14th January 2019. [Veru Inc. via Globe Newswire via SPi World News]
MIAMI, Jan. 14, 2019 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company, today announced that the clinical trial of the Company’s proprietary Tadalafil and Finasteride Combination tablet met the U.S. Food and Drug Administration’s (FDA) requirements for bioavailability and bioequivalence for the co-administration of tadalafil 5mg and finasteride 5mg dosed daily for benign prostatic hyperplasia (BPH) (Tad-Fin Combination Tablet).
Stability testing of commercially manufactured batches (GMP) of the Tad-Fin Combination Tablet required for submission of a New Drug Application (NDA) is in progress.
The Company has also requested a Pre-NDA meeting with FDA and anticipates submitting an NDA under the 505(b)(2) regulatory pathway in the second half of calendar year 2019.
Tad-Fin Combination Tablet combines two of the most popular medicines, tadalafil and finasteride, that are currently prescribed separately to treat lower urinary tract symptoms caused by an enlarged prostate also known as BPH. The co-administration of tadalafil and finasteride has been shown clinically to be more efficacious in treating BPH symptoms than either tadalafil or finasteride alone.* Our Tad-Fin Combination Tablet is proprietary and is designed to improve patient compliance and safety.
According to current FDA approved labeling, Tadalafil (CIALIS) (PDE5 inhibitor) is approved to treat both BPH and erectile dysfunction, and Finasteride (PROSCAR) (5 alpha-reductase inhibitor) is approved to treat symptoms of BPH, prevent the progression of BPH, reduce the risk of acute urinary retention and decrease the potential need for prostate surgery. Finasteride (PROPECIA) is also approved to treat male pattern hair loss.
“This successful clinical study for Tad-Fin Combination Tablet will allow Veru to rely on the safety and efficacy of PROSCAR and CIALIS for BPH in the FDA approval process without the requirement of a large clinical trial. This is an exciting milestone for Veru as the Tad-Fin Combination Tablet is our lead proprietary urology pharmaceutical medicine and the first drug for which we plan to submit an NDA to FDA later this year. We plan to use anticipated cash flow from sales of our urology specialty pharmaceuticals, like Tad-Fin Combination Tablet, to invest in our prostate cancer programs and to execute on our strategy to become the leading pharmaceutical company in providing products for the continuum of care for prostate cancer, said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “We believe our Tad-Fin Combination Tablet will be an attractive product for the multi-billion-dollar global market for BPH and substantially increase compliance and safety in men who suffer from BPH or BPH and erectile dysfunction.”
Veru is also advancing 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 has developed to avoid the “food effect” inherent in currently marketed formulations of the drug, allowing for potentially safer administration and improved patient compliance (NDA submission expected in 2019). Veru is also developing Tadalafil/Finasteride combination tablet. Tadalafil (CIALIS) is currently approved for treatment of BPH and erectile dysfunction and finasteride (PROSCARand PROPECIA) is currently approved for treatment BPH and male pattern hair loss. The co-administration of tadalafil and finasteride has been shown to be more effective for the treatment of BPH than either drug alone*(NDA submission expected in 2019).
Veru’s Female Health Company Division markets the FC2 Female Condom / FC2 Internal Condom, an FDA-approved product for the dual prevention of unwanted pregnancy and sexually transmitted infections, and the PREBOOST medicated individual wipe for the prevention of premature ejaculation. The FC2 Female Condom / FC2 Internal Condom is marketed commercially and in the public health sector both in the U.S. and globally. FC2 is available by prescription in the U.S. including through the virtual doctor smartphone app “HeyDoctor” at . FC2 improves the lives, health and well-being of women around the world. For PREBOOST Veru has a co-promotion and distribution agreement with Timm Medical Technologies, Inc., a specialty urology sales organization, and the Company also recently entered into a US distributor agreement with a premier and fast-growing men’s health and telemedicine company that discreetly sells men’s health products via the internet. To learn more about these products please visit .
Contact:Kevin Gilbert 786-322-2213
Globe Newswire: 13:00 GMT Monday 14th January 2019
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