Viveve (NSDQ:VIVE) said yesterday it won FDA clearance to continue enrollment in its Viveve II trial exploring the safety and efficacy of its Viveve system for improving sexual function in women following vaginal childbirth.
The approval came based off sufficient evidence to support continued enrollment and a lack of subject protection concerns which would preclude continuation, the Englewood, Colo.-based company said.
The Viveve II study is a randomized, double-blinded, sham-controlled trial which looks to enroll 250 patients at 25 sites across the US and Canada. The FDA requested a staged approach to enrollment initially with a safety review completed based on one-month follow-up data for an initial 25 subjects.
Viveve said that the FDA requested a second safety review will will be collected from an additional 25 subjects out to one month, and from the first 50 subjects at three months. During the second safety review, enrollment in the trial will continue up to 100 subjects.
The trial’s primary efficacy endpoint is intended to be mean change from baseline as measured by the Female Sexual Function Index at one year, with safety assessed over the same period. Secondary and exploratory endpoints in the trial include FSFI domain score improvements for desire, lubrication, orgasm, arousal, satisfaction and pain.
“This clearance to continue enrollment represents a major step forward in the progression of the Viveve II trial and for women seeking an improvement in sexual function following child birth. Following FDA review of the second stage of safety data, and approval of an IDE supplement to expand the study, Viveve plans to continue enrollment up to 250 patients,” CEO Scott Durbin said in a press release.
In June, Viveve said that it inked a settlement and licensing agreement with Thermigen and associated defendants to resolve a patent litigation claiming Thermigen improperly used Viveve intellectual property with its ThermiVa system.
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