FDA accepts application for tadalafil/finasteride combo capsule for BPH

The FDA has accepted a 505(b)(2) new drug application (NDA) for a daily capsule that combines tadalafil and finasteride (Tadfin capsules) for the treatment of patients with benign prostatic hyperplasia (BPH).¹

According to the FDA, “A 505(b)(2) application is an NDA that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant.”²

Tadfin 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. Currently, simultaneous administration of these 2 treatments, both at 5 mg, is FDA approved for treating the initial symptoms of BPH for up to 26 weeks. Tadfin is intended for men who have lower urinary tract symptoms and restricted urinary stream because of an enlarged prostate.

Under the Prescription Drug User Fee Act, the FDA is scheduled to make a decision on the NDA by the end of December 2021.

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.”³

Commenting on the NDA, Mitchell Steiner, MD, chairman, president and chief executive officer of Veru stated in a press release, “We believe FDA approval of Tadfin is possible toward the end of the current calendar year, with a launch shortly thereafter via telemedicine or out-license of product to specialty pharmaceutical companies.”

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.⁴

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 Reports Strong Second-Quarter Financial Results Based on Record High FC2 Prescription Revenues. Published online May 12, 2021 Accessed May 13, 2021. https://bit.ly/3vXpL7s.

2. FDA. A 505(b)(2) application is an NDA that contains full reports. Last updated April 27, 2020. Accessed February 23, 2021. https://bit.ly/3qMMvVy

3. 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

4. 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