Discovery history and clinical development of mirabegron for the treatment of overactive bladder and urinary incontinence.
Expert Opin Drug Discov
; 9(4): 433-48, 2014 Apr.
Article
en En
| MEDLINE
| ID: mdl-24559030
INTRODUCTION: Overactive bladder (OAB) and urinary incontinence, although not life-threatening, are very bothersome chronic health conditions. The limitations of current pharmacological treatment urge the need for novel drugs with alternative mechanisms of action. Huge efforts in this area of research led to the synthesis of several selective and potent ß3-adrenoceptor agonists that gained relevance through research during the late 80s and 90s. Mirabegron was the first compound of this new class of drugs that showed preclinical efficacy in several models of storage bladder dysfunction, together with a favorable human pharmacological profile. Having passed the proof-of-concept stage, an extensive clinical development and pharmacology program was performed during the last 10 years, involving >10,000 individuals, before mirabegron was granted marketing approval. AREAS COVERED: In this case history, the authors review the milestones in mirabegron's discovery based on a systematic literature review. EXPERT OPINION: Thanks to its tolerability and safety/efficacy balance, mirabegron has potential to fill a need for new treatment options for OAB, and paves the way for further development of a completely new class of drugs aimed to treat this condition. However, the exact role of mirabegron in clinical practice has yet to be defined. Further studies are needed in order to clarify, together with post-launch information, critical safety issues and cost-effectiveness in head-to-head comparison with current standard treatments.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Tiazoles
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Incontinencia Urinaria
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Vejiga Urinaria Hiperactiva
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Agonistas de Receptores Adrenérgicos beta 3
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Agentes Urológicos
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Acetanilidas
Tipo de estudio:
Prognostic_studies
/
Systematic_reviews
Límite:
Animals
/
Humans
Idioma:
En
Revista:
Expert Opin Drug Discov
Año:
2014
Tipo del documento:
Article
País de afiliación:
Italia
Pais de publicación:
Reino Unido