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Alibra (VIVUS).

A A Qureshi1

  • 1Cardiovascular Research Centre for Cardiovascular Biology and Medicine, Rayne Institute, St Thomas' Hospital, London, UK. Aasim.A.Qureshi@kcl.ac.uk

Current Opinion in Investigational Drugs (London, England : 2000)
|September 22, 2001
PubMed
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VIVUS investigated a combination therapy for impotence using alprostadil and prazosin via the MUSE system. Regulatory applications were withdrawn, but discussions with authorities continue.

Area of Science:

  • Pharmacology
  • Urology
  • Drug Development

Background:

  • VIVUS developed a combination therapy for impotence featuring alprostadil and prazosin delivered via the MUSE system.
  • This combination aimed to reduce alprostadil dosage and associated pain, potentially offering increased efficacy.
  • It was positioned as an alternative to MUSE-alprostadil.

Purpose of the Study:

  • To evaluate the efficacy and safety of a novel combination therapy for erectile dysfunction.
  • To assess the potential benefits of prazosin in reducing alprostadil dosage and improving treatment outcomes.

Main Methods:

  • The combination therapy underwent Phase III clinical trials.
  • Regulatory submissions, including an NDA to the US FDA and marketing authorization applications in Europe, were made.

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Main Results:

  • Phase III trials were completed by September 1999.
  • VIVUS withdrew its New Drug Application (NDA) in the US and its marketing authorization application in Europe.
  • The company is currently in discussions with regulatory authorities regarding the withdrawn applications.

Conclusions:

  • The alprostadil/prazosin MUSE combination therapy development was halted following withdrawal of regulatory applications.
  • Regulatory discussions are ongoing with the FDA and EMEA.
  • Abbott Laboratories holds exclusive rights for related products in specified markets.