title: Alibra (VIVUS).
abstract: VIVUS is developing a combination therapy for the potential treatment of impotence consisting of alprostadil and prazosin (an alpha-adrenoceptor blocker) for delivery via its transurethral MUSE system. The therapy is being developed as an alternative to MUSE-alprostadil, and the company believes the prazosin component has the ability to reduce the dose of alprostadil necessary, and hence reduce associated pain. In addition, the mechanism of action of prazosin may be more efficacious in some individuals [2730761. By October 1998, the combination was in phase III trials, which were completed by September 1999 [3015441, [338753]. VIVUS submitted an NDA to the US FDA in December 1999 [319367], [344214] and in May 2000, the company filed for marketing authorization in Europe 13687511. In October 2000, the company was still awaiting regulatory approval from the FDA and the EMEA 1384823]. The company subsequently withdrew its NDA in the US. VIVUS Inc have also now withdrawn their application to the FDA and the EMEA for the alprostadil/prazosin MUSE combination product 1394552]. The company is still in discussion with these authorities regarding the application. Abbott Laboratories has exclusive rights for MUSE-alprostadil and Alibra in select markets, including Europe, Japan, Australia, New Zealand, and South and Central America [371435].
authors.affiliation: Cardiovascular Research Centre for Cardiovascular Biology and Medicine, Rayne Institute, St Thomas' Hospital, London, UK. Aasim.A.Qureshi@kcl.ac.uk
authors.forename: A A
authors.initials: AA
authors.lastname: Qureshi
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000008:administration & dosage*; D000527:Alprostadil / Q000008:administration & dosage* / Q000627:therapeutic use; D000818:Animals; D002986:Clinical Trials as Topic; D004338:Drug Combinations; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D011224:Prazosin / Q000008:administration & dosage* / Q000627:therapeutic use; D014665:Vasodilator Agents / Q000008:administration & dosage*
chemical_list: D000317:Adrenergic alpha-Antagonists; D004338:Drug Combinations; D014665:Vasodilator Agents; C438283:alprostadil, prazosin drug combination; D000527:Alprostadil; D011224:Prazosin