Apricus Biosciences said that the Vitaros drug-device combination human factor testing study required by the Food and Drug Administration (FDA) has begun.
Vitaros is a product candidate in the U.S. to treat erectile dysfunction; it is in-licensed from Warner Chilcott Co., Inc., which is a subsidiary of Allergan, Apricus said in a press release.
“In November of 2016, the FDA designated Vitaros as a drug-device combination and required Apricus to provide additional information regarding the proper use of the applicator in the planned NDA re-submission,” Richard Pascoe, Apricus CEO, said in the release. “We have since confirmed the necessary regulatory requirements for a drug-device combination product and have initiated the required human factors study which we believe is in accordance with the FDA guidance. We expect this study will be completed in the second quarter of this year and the results will be incorporated into our planned Vitaros NDA re-submission, which remains on track for the third quarter of this year.”
Apricus is a biopharmaceutical company advancing innovative medicines in urology and rheumatology with two product candidates in development, Apricus said.
The other product candidate is RayVa. RayVa “is in Phase 2 development to treat circulatory disorder Raynaud’s phenomenon, secondary to scleroderma, for which Apricus owns worldwide rights,” Apricus said.