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-  In the two clinical studies, ABT-894 was well tolerated and demonstrated a good safety profile

-  At the tested doses, ABT-894’s effect on pain reduction did not support continued development in neuropathic pain

NeuroSearch and Abbott have evaluated ABT-894, an α4β2-specific neuronal nicotinic receptor (NNR) agonist, in a clinical Phase II programme for the treatment of diabetic neuropathic pain. 

NeuroSearch will disclose financial guidance for 2009 in connection with the company’s 2008 full year announcement on 4 March 2009.

Chairman of the Board

Contact persons:

Flemming Pedersen, CEO, telephone: +45 2148 0118

Hanne Leth Hillman, Vice President, Director of Investor Relations & Corporate Communications, telephone: +45 4017 5103

Thomas Hofman-Bang

ABT-894 was discovered under a drug discovery collaboration between NeuroSearch and Abbott (1999-2003) in the field of NNR modulators.  Apart from ABT-894 in ADHD, the portfolio of NNR products under the continued collaboration with Abbott include also ABT-107 in Phase I development as a potential new treatment for Alzheimer’s disease and schizophrenia, as well as ABT-560. 

NeuroSearch and Abbott have also evaluated ABT-894 in a Phase II study in adult ADHD (Attention Deficit Hyperactivity Disorder). Results from this study were disclosed in July 2008.

Safety results from the pain studies demonstrated a low incidence of adverse events at all ABT-894 dose levels comparable to placebo. Furthermore, there was no indication of consistent heart rate or blood pressure changes compared to placebo at any ABT-894 dose.

The primary endpoint assessed in both Phase II studies was the change in the weekly average pain score as calculated from the subjects’ daily pain diary. ABT-894 did not demonstrate an adequate effect in either study. These Phase II efficacy results do not support further development of ABT-894 in neuropathic pain, and the pain programme will be discontinued. 

The Phase II programme consisted of two parallel, randomised, double-blinded, and placebo-controlled studies – one of which was also active-controlled, comprising a total of 404 patients suffering from diabetic neuropathic pain. Both studies compared the efficacy and safety of eight-weeks’ treatment of different doses of ABT-894 to placebo. One study included duloxetine (Cymbalta®) as an active comparator.