# Glaxo Pipeline



## SpAsMaN* (May 11, 2002)

You maybe will be able to get it outside the current trial on IBS from your doc.







More on that in few sec...


----------



## SpAsMaN* (May 11, 2002)




----------



## SpAsMaN* (May 11, 2002)




----------



## SpAsMaN* (May 11, 2002)

Another IBS pipeline







: http://www.phrma.org/newmedicines/newmedsd...0Syndrome%7C162 Among the potential new products near term is alvimopan, a peripherally-acting mu-opioid receptor antagonist. After open abdominal surgery, many patients experience postoperative ileus, a temporary bowel impairment of variable duration that frequently prolongs hospital stay. Data from completed Phase III studies have shown that, when compared with placebo, alvimopan accelerates the recovery of gastrointestinal function and permits earlier hospital discharge. Alvimopan is also being developed to manage chronic opioid bowel dysfunction which negatively impacts the quality of life for millions of patients using opioid analgesics such as morphine for pain relief. Developed with Adolor Corporation, an application for approval of alvimopan for the management of postoperative ileus is targeted for filing with the FDA late in the first half of 2004.


----------



## SpAsMaN* (May 11, 2002)

From sept.2004: http://www.pslgroup.com/dg/244ffe.htm I will be back...!


----------



## SpAsMaN* (May 11, 2002)




----------



## SpAsMaN* (May 11, 2002)

Peripheral Opioid Receptors in theGastrointestinal Tract Just as there are opioid receptors on peripheral nerves that regulate the transmission of pain signals into the spinal cord, there are also opioid receptors in the gastrointestinal tract that regulate functions such as motility and water secretion and absorption. Stimulation of these gastrointestinal mu opioid receptors by morphine or other opioid analgesics causes constipation associated with opioid bowel dysfunction. Scientists have shown that blocking these receptors with opioid receptor antagonist drugs during administration of morphine or other opioid analgesics may prevent or reverse the effects of opioid bowel dysfunction. However, currently marketed opioid receptor antagonist drugs also cross the blood-brain barrier and enter the brain where they can block the primary pain relieving effects of opioid analgesics such as morphine. These findings have created the opportunity to develop a new class of opioid antagonists which, when taken with opioid analgesics, are designed to block the side effects of the opioid analgesics on the GI tract but not the desired analgesic activity of opioid drugs because they are designed not to cross the blood-brain barrier. Enteregï¿½ (alvimopan) is an example of this approach to novel drug discovery. http://www.adolor.com/GI_opioid_receptors.htm ***Which probably explain why i have had head aches with Naltrexone,an Opioids anta-gonist who pass the blood-brain barrier.


----------



## SpAsMaN* (May 11, 2002)

Postoperative Ileus (POI) ClinicalDevelopment Program Our Enteregï¿½ POI Phase 3 clinical program included four studies that have been completed. Three of these studies (POI 14CL302, POI 14CL308 and POI 14CL313) were double-blind, placebo-controlled multi-center studies each designed to enroll subjects scheduled to undergo certain types of major abdominal surgery and receiving opioids for pain relief. Under the protocols, subjects were randomized into three arms to receive placebo, 6 mg or 12 mg doses of Entereg. The primary endpoint in these three efficacy studies was time to recovery of gastrointestinal (GI) function, a composite measure of the time to recovery of both upper and lower GI function, as defined by time to tolerability of solid foods and time to first flatus or first bowel movement, whichever occurred last. The fourth POI clinical study in our Phase 3 program, POI 14CL306, was a double-blind, placebo-controlled multi-center observational safety study under which subjects were scheduled to undergo total abdominal simple historectomy and were randomized to receive either Entereg 12 mg or placebo. The primary objective of this study was to evaluate the safety of Entereg. The four Phase 3 clinical trials enrolled over 2,100 subjects in total. Our development partner, GSK is currently conducting a substantial Phase 3 POI study in Europe. Adolor completed submission of a New Drug Application to the Food and Drug Administration for use of Entereg capsules in POI on June 28, 2004. The FDA has designated Entereg as a Fast Track product for the management of POI. The Fast Track Programs of the FDA are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. http://www.adolor.com/entereg_poi_development.htm


----------



## SpAsMaN* (May 11, 2002)

Another link from the Adolor site:Enteregï¿½ (alvimopan)/Opioid Analgesic Combination Program We are exploring the development of an analgesic product candidate that would be a combination of our lead product candidate, Entereg, and an opioid that would be intended to produce the pain relief of an opioid while reducing side effects, such as constipation, nausea and vomiting. http://www.adolor.com/entereg_combo_development.htm


----------



## SpAsMaN* (May 11, 2002)

The alvimopan New Drug Application (NDA) is currently under review by the US FDA.Alvimopan will not be available in the US till after review and approval by FDA.An application to Canadian regulatory authorities is currently planned. John Fort, MDVP, Medical AffairsAdolor Corp 16012005


----------

