FDA news recap in benign urology for Q3 2025

The landscape in benign urology continues to see steady progress. In Q3 of 2025, this progress was marked by key priority review designations, which set the stage for decisions in hypoactive sexual desire disorder and uncomplicated gonorrhea in the months ahead. Q3 also welcomed approvals for novel devices for urge urinary incontinence and cystoscopy, highlighting the continued technologic advances that are transforming care.

As we enter the final months of the year, here’s a look back at the notable regulatory moves in benign urology between July and September.

FDA grants priority review to expanded indication of flibanserin in HSDD

Date: July 24, 2025

Indication:Hypoactive sexual desire disorder (HSDD) in postmenopausal women

Summary: In July, the FDA granted priority review to a supplemental application seeking an expanded approval of flibanserin (Addyi, 100 mg) to treat HSDD in postmenopausal women.¹ Flibanserin was previously approved by the FDA in 2015 to treat HSDD in certain premenopausal women.

FDA grants priority review to gepotidacin for uncomplicated urogenital gonorrhea

Date: August 12, 2025

Indication: Uncomplicated urogenital gonorrhea in patients 12 years of age and older (weighing ≥45 kg)

Summary: In August, the FDA granted priority review to a supplemental new drug application (sNDA) seeking approval of gepotidacin as an oral treatment for uncomplicated urogenital gonorrhea in patients 12 years of age and older (weighing ≥45 kg).² The agency issued a Prescription Drug User Fee Act target action date for the application is December 11, 2025.

Gepotidacin was previously approved in March 2025 for female adult and pediatric patients 12 years of age and older (weighing ≥40 kg) with uncomplicated urinary tract infection.

FDA approves Altaviva device for urge urinary incontinence

Date: September 19, 2025

Indication: Urge urinary incontinence

Summary:Medtronic announced on September 19, 2025, that the FDA had approved its Altaviva device, an implantable tibial neuromodulation therapy for patients with urge urinary incontinence.³ The approval was supported by data from the TITAN 2 trial, which enrolled patients across clinical trial sites in the US.

FDA grants 510(k) clearance to Zenflow single-use cystoscope

Date: September 30, 2025

Indication: Cystoscopy

Summary:In late September, Zenflow announced FDA 510(k) clearance for their Zenflow Spring Scope & Camera Control Unit.⁴ The device features a 12 French working channel, which is the largest of any flexible single-use cystoscope, enabling improved visualization during flexible cystoscopy.In addition to the Spring Scope, the Zenflow Spring platform also includes the investigational Spring Implant and Delivery system.

REFERENCES

1. FDA grants Priority Review for Addyi (flibanserin) paving the way for expanded access to treat low sexual desire in postmenopausal women. News release. Sprout Pharmaceuticals. July 24, 2025. Accessed October 2, 2025. https://www.prnewswire.com/news-releases/fda-grants-priority-review-for-addyi-flibanserin-paving-the-way-for-expanded-access-to-treat-low-sexual-desire-in-postmenopausal-women-302512883.html

2. Gepotidacin accepted for priority review by the US FDA for the oral treatment of uncomplicated urogenital gonorrhoea. News release. GSK. August 11, 2025. Accessed October 2, 2025. https://www.gsk.com/en-gb/media/press-releases/gepotidacin-accepted-for-priority-review-by-the-us-fda-for-the-oral-treatment-of-uncomplicated-urogenital-gonorrhoea/

3. Medtronic secures FDA approval for the Altaviva device, a simple experience for treating urge urinary incontinence. News release. Medtronic plc. September 19, 2025. Accessed October 2, 2025. https://news.medtronic.com/2025-09-19-Medtronic-secures-FDA-approval-for-the-Altaviva-TM-device,-a-simple-experience-for-treating-urge-urinary-incontinence

4. Zenflow receives FDA 510(k) clearance for first-of-its-kind single-use cystoscope. News release. Zenflow. September 30, 2025. Accessed October 2, 2025. https://www.globenewswire.com/news-release/2025/09/30/3158543/0/en/Zenflow-Receives-FDA-510-k-Clearance-for-First-of-Its-Kind-Single-Use-Cystoscope.html