Alprostadil topical - Apricus Biosciences

Drug Profile

Alprostadil topical - Apricus Biosciences

Alternative Names: Alprox-TD; Befar; Cold Chain Vitaros; Femprox; RayVa; Room Temperature Vitaros; Topical ED treatment - Apricus; Virirec; Vitaros; Vytaros; WC-3036

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator NexMed
  • Developer Apricus Biosciences; Ferring Pharmaceuticals; Laboratoires Majorelle; Recordati
  • Class Erectile dysfunction therapies; Monounsaturated fatty acids; Muscle relaxants; Peripheral vasodilators; Prostaglandins; Small molecules
  • Mechanism of Action Prostaglandin E1 agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No
  • Available For Licensing Yes - Erectile dysfunction; Female sexual dysfunction; Raynaud's disease

Highest Development Phases

  • Marketed Erectile dysfunction
  • Phase II Raynaud's disease
  • Suspended Female sexual dysfunction
  • No development reported Premature ejaculation; Wounds

Most Recent Events

  • 31 Aug 2017 The US FDA acknowledges receipt of a resubmitted New Drug Application of alprostadil for Erectile dysfunction
  • 31 Aug 2017 The US FDA assigns PDUFA action date of February 17, 2018 for alprostadil topical (Vitaros™) for Erectile dysfunction
  • 29 Aug 2017 Apricus Biosciences files NDA resubmission for Alprostadil topical for the treatment of Erectile dysfunction
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