FDA approves tadalafil/finasteride combo capsule for BPH

The FDA has approved a daily capsule (trade name, Entadfi) that combines tadalafil and finasteride for the treatment of urinary tract symptoms related to benign prostatic hyperplasia (BPH).¹

Entadfi combines 5 mg of the PDE-5 inhibitor tadalafil (Cialis; Eli Lily and Company) with 5 mg of the 5-ARI finasteride (Proscar; Merck) into 1 capsule formulation. The FDA-approved indication is to "initiate treatment of the signs and symptoms of benign prostatic hyperplasia in men with an enlarged prostate for up to 26 weeks."

The efficacy and safety of the coadministration of tadalafil and finasteride has been well established over the past decade. An international, randomized, double-blinded study of approximately 700 men with BPH published in 2014 concluded that, “The coadministration of tadalafil/finasteride provides early improvement in lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement. Tadalafil/finasteride coadministration also improves erectile function in men who have comorbid erectile dysfunction.²

“FDA approval of Entadfi, a new treatment for BPH, is a significant execution milestone for Veru and an important step in expanding revenues from our commercial Sexual Health Division. We use these revenues to invest and advance our late clinical stage oncology drug pipeline portfolio as well as our global phase 3 COVID clinical study,” Mitchell Steiner, MD, chairman, president and chief executive officer of Veru, the developer of Entadfi, stated in a news release.

“We are in the process of augmenting our marketing and sales efforts by adding commercialization partners in the US and ex-US. We expect to begin commercialization in early calendar year 2022,” added Steiner.

Veru Pipeline

The oncology biopharmaceutical company Veru has several other urology products in its pipeline, including VERU-111. Phase 1b study findings shared during the 2021 Genitourinary Cancers Symposium demonstrated that VERU-111 showed promising activity in patients with metastatic castration-resistant prostate cancer who had progressed on androgen receptor–targeted therapy.³

In the study, VERU-111 induced a prostate-specific antigen (PSA) decline in 6 of 10 men who received at least four 21-day cycles of continuous dosing with the investigational tubulin inhibitor. Further, PSA declines of ≥30% and ≥50% were achieved by 4 and 2 patients, respectively. Two men had partial responses and 8 men achieved stable disease as best objective tumor response. Two additional objective responses occurred in patients who did not reach 4 cycles of continuous dosing.

References

1. Veru Announces FDA Approval of ENTADFI, a New Treatment for Benign Prostatic Hyperplasia. Published online December 13, 2021. Accessed December 13, 2021. https://bit.ly/3dRR77S.

2. Casabé A, Roehrborn CG, Da Pozzo LF, et al. Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia. J Urol. 2014;191(3):727-733. doi: 10.1016/j.juro.2013.09.059

3. Markowski MC, Eisenberger MA, Tutrone RF, et al. Clinical study of VERU-111, an oral cytoskeletal disruptor in men with metastatic castration resistant prostate cancer (mCRPC) who failed an androgen receptor targeting agent. J Clin Oncol. 2021(suppl 6):131. doi:10.1200/JCO.2021.39.6_suppl.131