Brad, ther are 2 studies, one being the phase II trial you mentioned and the other being the studied conducted for the patent.The primary goal of the Phase 2 trial was saftey and the FDA requires these studies to meet certain requirements.Quote from Remi Barbier, president and chief executive officer of Pain Therapeutics
http://www.msnbc.com/news/919653.asp?cp1=1 "The phase II test was designed mostly to assess safety, and the company now plans to start a larger, Phase III efficacy trial � the last step before seeking FDA approval."Secondary was relief of symtoms, but during the study they did not adjust the dose, as the aim was not to establish a recommended dose.The study in the patent was started at 2mg/day then adjusted to between 1-3mg/day, adjusting dosage for each individual.So my point was the 2mg/day dose is probably a more accurate representation of what people would require in the real world. But you are right that phase II study did report a 75% inprovement in patients.Tom, I dont know anything about the comparative effects of 5htp antagonists, but it is my understanding that lotronex blocks the action of seroton at the 5htp-3 receptor while zelnorm blocks serotonin at the 5htp-4 receptor. My thinking is that these two receptors modulate gut motility in combination. As for naltrexone, yes naltrexone has a completly different mechanism of action, so is a completely different class of drug.Quote from same guy as above: �The traditional view of IBS is that the flusher is broken � it iseither flushing too quickly or not quickly enough, causing diarrhea or constipation,� Barbier said.�We disagree with that point of view. We don�t think the flusher is the problem. We think it is an imbalance of opioids in the gut. We provide the patient with an external source of opioid antagonists to restore bowel function.�So yeah their view is that naltrexone normalizes the opioids in the gut.