AGI-006 is in
Phase II development for the treatment of Functional
Dyspepsia
AGI-006 is an oral dosage form of arbaclofen (the R-isomer of baclofen) which is being developed by AGI for the treatment of functional dyspepsia in both men and women.
Functional dyspepsia, also referred to as non-ulcer dyspepsia or NUD, is a cluster of chronic or recurrent upper GI symptoms, including early satiety, abdominal distension and fullness and discomfort and pain, not associated with any known structural abnormality.
Estimates as to the prevalence of functional dyspepsia vary, with some studies suggesting that it affects up to 25 per cent of the US population annually and accounts for up to 5% of all visits to primary care physicians. No prescription therapeutic drug products have been found to have a high success rate in the treatment of functional dyspepsia and there are as yet no therapeutic drug products approved for its treatment in the US. AGI believes that functional dyspepsia represents an unmet medical need and that there are significant market opportunities for new therapeutic drug products which can treat the disorder.
A solid oral dosage form of AGI-006 has been developed and a Phase II clinical trial evaluating the efficacy of AGI-006 in the treatment of functional dyspepsia in both men and women is currently ongoing.
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