The Food and Drug Administration (FDA) has approved Entadfi (finasteride and tadalafil) for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks.

Entadfi is a fixed-dose combination of finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor. The approval was based on a randomized, double-blind, placebo-controlled phase 3 study (ClinicalTrials.gov Identifier: NCT01139762) that evaluated the efficacy and safety of tadalafil plus finasteride in 696 men.

Patients were randomly assigned to receive tadalafil 5mg with finasteride 5mg or placebo with finasteride 5mg. The primary endpoint was the change from baseline to week 12 in total International Prostate Symptom Score (IPSS).

Findings showed a statistically significant improvement in the signs and symptoms of BPH when tadalafil was administered with finasteride vs placebo plus finasteride (mean total IPSS change from baseline to week 12: -5.2 vs -3.8; treatment difference, -1.4; P <.001). Improvement in total IPSS was observed starting at week 4 (-4.0 vs -2.3 for placebo; treatment difference, -1.7; P <.001) and continued through week 26 (-5.5 vs -4.5 for placebo; treatment difference, -1.0; P =.022).

Entadfi is not recommended for more than 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks and the incremental benefit beyond 26 weeks is unknown.

In a 4-year study, finasteride monotherapy was found to be associated with impotence, decreased libido, decreased volume of ejaculate, breast enlargement, breast tenderness, and rash. Headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb were most commonly reported with tadalafil.

Entadfi is supplied as a capsule containing a combination of finasteride 5mg and tadalafil 5mg in 30- or 90-count bottles. The product is expected to be available in early 2022.

References

  1. Veru announces FDA approval of Entadfi, a new treatment for benign prostatic hyperplasia. News release. Veru Inc. Accessed December 13, 2021. https://www.globenewswire.com/news-release/2021/12/13/2350788/11676/en/Veru-Announces-FDA-Approval-of-ENTADFI-a-New-Treatment-for-Benign-Prostatic-Hyperplasia.html
  2. Entadfi. Package insert. Veru Inc.; 2021. Accessed December 13, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215423s000lbl.pdf.