TADFIN™ (5mg Tadalafil and 5mg Finasteride tablet) for BPH
Veru’s 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) (TADFIN™ Combination Tablet).
Stability testing of commercially manufactured batches (GMP) of the TADFIN™ 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.
TADFIN™ 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 TADFIN™ 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.
*Casabe A et al. J or Urol 2014; 191:717-733