Switzerland's Addex Pharmaceuticals has released clinical data showing that the modified-release formulation of ADX10059 has improved commercial potential.
Tolerability was dramatically improved, while a statistically-significant reduction in gastroesophageal reflux was achieved for the second time in clinical trials of this product. The firm says novel formulation is appropriate for longer term twice-daily dosing in Phase IIb gastroesophageal reflux disease and migraine prophylaxis studies scheduled to start in the fourth quarter. ADX10059 is a first-in-class negative allosteric modulator of metabotropic glutamate receptor 5.
In the study, the selected modified release formulation was absorbed at a reduced rate while maintaining the total exposure achieved by the original API-filled capsules. No adverse events were observed with the formulation selected for Phase IIb testing. In contrast, seven of 12 subjects taking the original ADX10059 250mg API in capsules experienced side effects such as dizziness, drunk feeling and flushing.
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