Duloxetine Eli Lilly & Co

Curr Opin Investig Drugs. 2000 Sep;1(1):116-21.

Abstract

Lilly is developing duloxetine, a 5-HT and norepinephrine uptake inhibitor as a potential treatment for depression and urinary incontinence. In Japan, it is being jointly developed with Shionogi [187401]. Phase III trials for depression and phase II trials for urinary incontinence are underway in Japan [296442,328887]. Lilly expects to file for depression in 2002 and phase III trials for urinary incontinence are planned to start enrollment by the end of 2000 [358429,370526,373870]. Duloxetine has a half-life of 10 to 15 h in humans, and parameters reach a steady-state after 3 days of daily administration. In a 6-week, open-label study duloxetine was safe and well tolerated in 79 clinically depressed patients. Clinical response occurred in 78% of patients, and remission occurred in 60%. Insomnia and nausea occurred with an incidence of 20% [300881]. Duloxetine may offer advantages over existing antidepressants, such as Lilly's fluoxetine, because of faster recovery and fewer side effects [190226]. In June 2000, Morgan Stanley Dean Witter predicted duloxetine would reach the market in 2002 with annual sales in this year of US $50 million, rising to $200 million in 2005 [373870]. In February 1999, Deutsche Bank predicted Lilly's sales at US $200 million in 2002 rising to $400 million in 2003 [316821]. In May 2000, Deutsche Bank had made further predictions, stating that filing for duloxetine is expected in the fourth quarter of 2001, and peak sales are expected to exceed US $500 million. Also in February 1999, Lehman Brothers predicted the first major launch date (US and ex-US) to be 2002, with the year of peak sales to be 2008 [319225]. In August 1999, this prediction changed, and the expected launch date became 2001, with an 80% probability of reaching the market and sales peaking at US $150 million in 2012 [349228].

Publication types

  • Review

MeSH terms

  • Adrenergic Uptake Inhibitors / adverse effects
  • Adrenergic Uptake Inhibitors / chemical synthesis
  • Adrenergic Uptake Inhibitors / pharmacology
  • Adrenergic Uptake Inhibitors / therapeutic use*
  • Animals
  • Antidepressive Agents, Second-Generation / adverse effects
  • Antidepressive Agents, Second-Generation / chemical synthesis
  • Antidepressive Agents, Second-Generation / pharmacology
  • Antidepressive Agents, Second-Generation / therapeutic use*
  • Clinical Trials as Topic
  • Contraindications
  • Depressive Disorder / drug therapy*
  • Drugs, Investigational / adverse effects
  • Drugs, Investigational / chemical synthesis
  • Drugs, Investigational / pharmacology
  • Drugs, Investigational / therapeutic use*
  • Duloxetine Hydrochloride
  • Humans
  • Thiophenes / adverse effects
  • Thiophenes / chemical synthesis
  • Thiophenes / pharmacology
  • Thiophenes / therapeutic use*
  • Urinary Incontinence / drug therapy*

Substances

  • Adrenergic Uptake Inhibitors
  • Antidepressive Agents, Second-Generation
  • Drugs, Investigational
  • Thiophenes
  • Duloxetine Hydrochloride