Second US pivotal phase III, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of topical alprostadil in patients with mild to severe erectile dysfunction
Phase of Trial: Phase III
Latest Information Update: 31 Aug 2017
At a glance
- Drugs Alprostadil (Primary)
- Indications Erectile dysfunction
- Focus Registrational; Therapeutic Use
- 31 Aug 2017 According to an Apricus Biosciences media release, the company announces that the U. S. Food and Drug Application has acknowledged receipt its resubmitted NDA for Vitaros (alprostadil, DDAIP.HCI ) and considers it a complete, class 2 response to Apricus 2008 action letter. The PDUFA (Prescription Drug User Fee Act) goal date for completion of FDA's review of Vitaros NDA is set for 17 Feb 2018, which is the standard six-month review period for NDA resubmission.
- 29 Aug 2017 According to an Apricus Biosciences media release, the company recently filed its resubmission of a New Drug Application (NDA) for Vitaros (alprostadil, DDAIP.HCl) with the U.S. Food and Drug Administration (FDA). Apricus anticipates a six-month review by the FDA with a projected PDUFA (Prescription Drug User Fee Act) goal date in the first quarter of 2018, which it expects the FDA to acknowledge within 30 days of the NDA filing date.
- 06 Apr 2016 According to an Apricus Biosciences media release, the company is planning resubmission of NDA for topical alprostadil for erectile dysfunction with the US FDA in the third quarter of 2016, and is expecting potential approval in first half of 2017.