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Apricus Biosciences, Inc., a biopharmaceutical company advancing innovative medicines in urology and rheumatology, announced that the Vitaros drug-device combination human factor testing study required by the Food and Drug Administration (FDA) is underway.
“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,” stated Richard W. Pascoe, chief executive officer. “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, vitaros drug device, human factors study
