Adolor Corporation Initiates Clinical Testing In Opioid Bowel Dysfunction Program

Main Category: Pain / Anesthetics
Also Included In: GastroIntestinal / Gastroenterology
Article Date: 30 Nov 2009 - 3:00 PDT

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Adolor Corporation (NasdaqGM:ADLR) announced the initiation of clinical testing of ADL7445, its proprietary, oral mu opioid receptor antagonist for the treatment of Opioid Bowel Dysfunction (OBD). The Phase 1, single ascending dose trial in healthy volunteers will assess safety and tolerability of the compound and will be followed by a multiple ascending dose study in early 2010.

Early next year, the Company also expects to initiate a clinical study of a second compound for OBD, ADL5945, in a parallel, early-stage clinical development program. ADL5945 was in-licensed from Eli Lilly in September 2009 and has a different chemical structure and pharmacokinetic profile than ADL7445.

"We are very pleased to commence clinical testing in our OBD Program with the first of two promising compounds," said Eliseo Salinas, M.D., Senior Vice President and Chief Medical Officer. "Our clinical development team possesses a wealth of experience in this therapeutic area, and we are committed to developing products that will address this large, unmet need."

About Opioid Bowel Dysfunction

Opioids are highly effective in the treatment of pain and are widely used to treat moderate-to-severe persistent pain such as pain associated with, or as a result of, back pain, arthritis and other chronic pain conditions. However, the use of opioids is associated with gastrointestinal (GI) side effects such as constipation, abdominal pain and discomfort, bloating, gastro-oesophageal reflux and loss of appetite. These GI effects, which do not resolve over time, occur when opioids bind to mu-opioid receptors in the gut, reducing gastrointestinal motility and secretions. The consequences are not only distressing, but they may, in some patients, be dose-limiting for the pain therapy, which can then interfere with adequate pain control.

There currently are no approved oral drugs specifically for the treatment of GI adverse events associated with opioid use for persistent pain. Taking stool softeners and/or bowel stimulants, increasing daily fluid and fiber intake and increasing exercise are methods often used to manage this condition. Laxatives may provide limited relief for some patients, but also can be associated with side effects such as abdominal cramping, bloating and unpredictability of effect, and are not recommended for long-term use.

Source
Adolor Corporation

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