FDA approval sought for peripheral neurostimulator for overactive bladder

An FDA pre-market approval (PMA) application has been filed by Valencia Technologies for its eCoin Peripheral Neurostimulator system for overactive bladder (OAB), the company reported in a press release.¹

The PMA is primarily based on a pivotal trial in which 6-month interim efficacy data showed that eCoin led to a complete (100%) improvement in urgency urinary incontinence (UUI) in a quarter of the patients, and a ≥50% improvement in UUI in 71% of the patients.²

Following a PMA filing, formal feedback is provided by the FDA within 90 days, and the agency is required to complete its review and issue a decision within 180 days.

“Given our compelling pivotal study results and our interactions with the FDA to date, we are extremely confident in our filing. Our modular approach, which allowed us to obtain formal FDA feedback on two-thirds of the submission while awaiting final clinical data, puts us in a strong position to quickly address any FDA comments as they review the final clinical data component and answers to all previous formal feedback. We look forward to completing this final review process and to bringing eCoin to overactive bladder patients as quickly as possible,” Stacy Chambliss, chief administrative officer and chief of clinical trials at Velencia, stated in the press release.

The eCoin device is a tibial neurostimulator that is the shape and size of a nickel. It is implanted in the lower leg under local anesthetic in an office or outpatient procedure by a urologist or urogynecologist. The procedure takes about 20 minutes.

The open-label, single-group assignment pivotal trial of eCoin (NCT03556891)3 included 133 patients with OAB with UUI. eCoin was a third- or fourth-line OAB therapy for these patients, who went through a washout period for any OAB medications. OAB drugs were not allowed during the trial. Patients were followed for at least 12 months.

The primary efficacy end point was the rate of patients having a ≥50% improvement in UUI episodes. This was measured through a 3-day voiding diary at 48 weeks following activation of eCoin.

At the 6-month interim efficacy analysis, the primary efficacy end point was exceeded by 20 points. Almost three-fourths (71%) of patients had a ≥50% improvement in UUI, and almost half (46%) of patients had a ≥75% improvement in UUI. As measured in episodes per day, the median percent change from baseline in UUI was 70%.

The findings also showed that eCoin treatment led to an overall 34% mean improvement in quality of life. Additionally, the tibial neurostimulator led to a 34% reduction in symptom bother, as measured by the OABq. There was an infection rate of 2.3%, with no other significant adverse events observed by the investigators, who intend to report their complete findings at an upcoming medical conference.

“We are extremely encouraged by this early data and I continue to believe in the paradigm shifting potential of eCoin,” Scott A. MacDiarmid, MD, the principal investigator of the trial, stated in a press release issued when these results were first announced.² “Despite the extremely high prevalence of OAB symptoms, many of my patients find current therapies as suboptimal and intolerable. We are overdue for a novel therapy that is well tolerated, reasonably priced, efficacious with minimal maintenance and most importantly appealing to patients, and I believe eCoin is that therapy.”

References

1. Valencia Technologies Files Pre-Market Approval (PMA) Application with U.S. FDA for eCoin Peripheral Neurostimulator. Accessed August 24, 2020.

2. Valencia Technologies Announces Interim Efficacy Data from eCoin® Pivotal Trial.

Published online March 2, 2020. https://bit.ly/2FKzAki. Accessed August 24, 2020

3. Pivotal Study of eCoin for OAB With UUI. NIH US National Library of Medicine: ClinicalTrials.gov. Posted June 14, 2018. https://bit.ly/34syCn3. Accessed August 24, 2020.