The developers of ADL 8-2698 are now seeking approval for Phase III trials, which would evaluate two dose levels of the drug.
ADL 8-2698 is a gastrointestinal tract-restricted opioid narcotic antagonist developed by the Adolor Corporation of Exton, Pennsylvania, USA.
|Effectiveness of ADL 8-2698 treatment:|
Highest dose - 100%
Lowest dose - 68%
Placebo - 30%
One study involved 26 patients with chronic opioid-induced constipation, and compared increasing doses of the drug over a 4-day period, with a placebo.
All patients who received the drug experienced bowel movements within 24 hours.
A second trial involved 75 patients and 3 different doses of the drug. The treatment was effective on all patients receiving the highest dose and on 68% of those receiving the lowest dose. Of patients taking placebo, 30% experienced a bowel movement within 12 hours.
A previous trial tested the drug in post-surgical ileus and found it reduced nausea and vomiting by 50% to 100%.
Dr John Farrar, the President of Adolor, said, "We believe the success of these two Phase II trials marks an important milestone in the further development of this compound, and complements the equally positive data that we have seen in post-surgical ileus patients."
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