On 24 July 2008 the Committee for Medicinal Products for Human Use (CHMP) in Europe adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product Duloxetine  produced by Boehringer Ingelheim in capsules of 20 mg, 30 mg, 40 mg and 60 mg. The indications are: 

1.  the treatment of moderate to severe Stress Urinary Incontinence (SUI) for women, and
2. the treatment of diabetic peripheral neuropathic pain (DPNP) in adults.

Duloxetine belongs to the pharmacotherapeutic group of other antidepressants.

Duloxetine is a combined serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor

Duloxetine is a combined serotonin (5-HT) and norepinephrine (NE) reuptake inhibitor. It weakly inhibits dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors. Due to its neuromodulatory action, duloxetine is believed to increase urethral tone and probably bladder capacity and thereby reduces stress urinary incontinence (SUI). Duloxetine normalised pain thresholds in neuropathic and inflammatory pain and attenuated pain behaviour in persistent pain. The pain inhibitory action of duloxetine is believed to be a result of potentiation of descending inhibitory pain pathways within the central nervous system.

Duloxetine in Stress Urinary Incontinence (SUI)

The benefits with Duloxetine Boehringer Ingelheim are its greater decrease in incontinence episode frequency when comparing with a placebo-treated group. Incontinence Quality of Life (I-QOL) questionnaire scores were significantly improved in the duloxetine-treated patient group compared with the placebo-treated group.

Duloxetine in diabetic painful neuropathy 

The efficacy of duloxetine as a treatment for diabetic neuropathic pain was established in randomised, double-blind, placebo-controlled, fixed dose studies in adults. The most common side effects are nausea, dry mouth, fatigue, insomnia, and constipation.  

The approved indication is: Duloxetine Boehringer Ingelheim is indicated for the treatment of moderate to severe Stress Urinary Incontinence (SUI) in women, and for the treatment of diabetic peripheral neuropathic pain in adults.  

Source: http://www.ema.europa.eu/pdfs/human/opinion/DuloxetineBI_33373008.pdf 

May 2010, Jan M. Keppel Hesselink, MD, PhD