Phase III Studies Begin of Alvimopan for Opioid-Induced Constipation

LONDON, and EXTON, Pa. -- GlaxoSmithKline PLC (GSK) and Adolor Corporation announced the start of an international Phase 3 clinical program to evaluate the investigational drug alvimopan (Entereg®), a peripherally acting mu-opioid receptor (PAM-OR) antagonist for the treatment of opioid-induced constipation (OIC) and associated symptoms. These distressing gastrointestinal (GI) side effects are experienced by many people taking opioids to treat chronic pain.

The Phase 3 clinical program is comprised of three studies with an expected enrollment of approximately 1,700 patients in North America, Europe and other parts of the world.

Millions of people worldwide take opioid analgesics to treat moderate to severe chronic pain. Constipation, a significant side effect of these treatments, is experienced by approximately half of patients, who may also experience abdominal pain and discomfort, bloating, and loss of appetite. OIC affects men and women of all ages who are taking opioids as painkillers, but many people suffer in silence with these GI side effects, and do not consult their physician or healthcare provider.

About Opioids
Opioid analgesics such as morphine are considered to be the most effective analgesics and are widely used to treat patients with moderate-to-severe pain. Opioid analgesics comprised approximately 75 percent of the US analgesics prescriptions in 2003, with an estimated total 240 million prescriptions written in the United States in the hospital, outpatient and physician office settings. This includes prescriptions for all acute and chronic pain.

About OIC and Associated Symptoms
Opioid-induced constipation (OIC) (sometimes referred to as opioid bowel dysfunction or OBD) is a drug-induced condition characterized by infrequent, difficult or incomplete bowel movement, straining and hard dry stools, often accompanied by other associated symptoms such as nausea, abdominal discomfort or pain, bloating and loss of appetite. OIC, which does not resolve over time, results when opioids bind to mu-opioid receptors in the gut, reducing gastrointestinal motility. The consequences are not only distressing, but are often severe enough to be dose limiting, which can then interfere with adequate pain control. There is currently no approved drug specifically for the treatment of OIC and the associated symptoms that restores normal bowel function. Taking stool softeners, 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 OIC patients, but can be also be associated with side effects such as abdominal cramping, bloating and unpredictability of effect and are not recommended for long-term use.

About Alvimopan
Alvimopan is an investigational peripherally-acting mu-opioid receptor antagonist (PAM-OR) designed to inhibit the negative effects of opioids, like morphine or codeine, on the gastrointestinal system without interfering with the analgesic effects on the central nervous system. Alvimopan is the first of this new class of compounds with a New Drug Application (NDA) that has been accepted for review by the U.S. Food and Drug Administration (FDA) for postoperative ileus (POI).

About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

About Adolor Corporation
Adolor Corporation is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products.

Source: GlaxoSmithKline; Adolor Corporation

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