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| GSK and Adolor Announce Initiation of Phase 3 Clinical Studies of Alvimopan in Opioid-Induced Constipation |
LONDON, and Exton, Pa., Sept. 12 /PRNewswire/ -- GlaxoSmithKline PLC (GSK) and Adolor Corporation (Nasdaq: ADLR) today announced the start of an international Phase 3 clinical program to evaluate the investigational drug alvimopan (Entereg(R)), 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. "The new studies aim to provide further clinical data on alvimopan in treating OIC in patients suffering chronic pain. Positive results from this trial could be the next step towards the introduction of a new treatment for OIC and associated symptoms with the potential to help a significant proportion of men and women suffering these often debilitating GI side effects of chronic opioid use," said Dr. Yvonne Greenstreet, Senior Vice President, Medicine Development Center at GlaxoSmithKline. 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 (Entereg(R)) 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). Adolor Corporation and GlaxoSmithKline are collaborating on the worldwide development and commercialization of alvimopan for POI and OIC, associated with the use of opioids to treat chronic pain. As previously announced, GSK is also conducting an ongoing study investigating efficacy in patients suffering pain associated with cancer. 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. For more information, visit GlaxoSmithKline on the World Wide Web at http://www.gsk.com. About Adolor Corporation Adolor Corporation (Nasdaq: ADLR) is a biopharmaceutical company specializing in the discovery, development and commercialization of novel prescription pain management products. Entereg(R) (alvimopan) is Adolor's lead product candidate under development for the management of the gastrointestinal side effects associated with opioid use. Adolor is developing a sterile lidocaine patch which is in Phase 2 clinical development for post-incisional pain. Adolor also has a number of discovery research programs focused on the identification of novel compounds for the treatment of pain. By applying its knowledge and expertise in pain management, along with ingenuity, Adolor Corporation is seeking to make a positive difference for patients, caregivers and the medical community. For more information, visit http://www.adolor.com. Forward looking statements This release, and oral statements made with respect to information contained in this release, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Such known risks and uncertainties relate to, among other factors: the risk that the alvimopan (Entereg(R)) Phase 3 Studies in opioid induced constipation are delayed; the risk that the results of these studies are not positive; the risk that regulatory approvals for alvimopan in opioid induced constipation are not achieved; the risk that Adolor may not obtain FDA approval for the new drug application for Entereg(R) in postoperative ileus (POI); the risk that further studies of Entereg(R) are not positive or have adverse safety findings; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; Adolor's history of operating losses since inception and its need for additional funds to operate its business; Adolor's reliance on its collaborators, including GlaxoSmithKline in connection with the development and commercialization of Entereg(R); market acceptance of Adolor's products, if regulatory approval is achieved; competition; and securities litigation. Further information about these and other relevant risks and uncertainties may be found in Adolor's Reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Adolor urges you to carefully review and consider the disclosures found in its filings, which are available in the SEC EDGAR database at http://www.sec.gov and from Adolor at http://www.adolor.com. Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Adolor undertakes no obligation to (and expressly disclaims any such obligation to) publicly update or revise the statements made herein or the risk factors that may relate thereto whether as a result of new information, future events, or otherwise. SOURCE GlaxoSmithKline; Adolor Corporation
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