Indantadol promising in animal models and phase Ib 

Animal studies were promising, and a phase Ib study as a proof of pfinciple study was positive too. The latter study was conducted in a human heat-capsaicin-induced pain model, and indantadol at a dose of 500 mg effectively reduced the area of secondary hyperalgesia to 67%.

Indantadol has two major metabolites - CHF-3567 and 2-aminoindane. The tolerability profile of indantadol was favorable compared to other NMDA antagonists. ^[1]  

Indantadol failed in phase IIb 

In the so called IN-STEP phase IIb study 162 patients suffering from neuropathic pain due to diabetes were treated in a 13-week, double blind, placebo controlled trial and were randomised to receive placebo or up to 400 mg of indantadol twice a day.

Tthe study showed 25% reduction in pain scores among patients treated with V3381 compared to baseline, and also marked reduction in the placebo-treated subjects. No significant difference between the two treatment groups could be reached.

The most common adverse event was dizziness experienced by 4% of patients in the placebo arm, versus 26% among those treated with indantadol.

Vernalis is unlikely to conduct further studies with V3381 in neuropathic pain due to diabetes.

Furthermore it is a severe dissapointment to find out that screening phase Ib POP studies in man are not predictable enough and cannot be used as a go- nogo. 

March 2010, prof. dr. Jan M. Keppel Hesselink 

Source: http://www.rttnews.com/Content/BreakingNews.aspx?Id=1249871&SM=1 

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