I had no idea why this one had been so strong lately.......is in my US nda predictions as a no...when is the pdufa date? Should have mentioned this one last week.... :-)
Press Release Source: Adolor Corporation
Adolor Reports Initial Results from GSK European Phase 3 Study of Alvimopan
Thursday December 23, 6:59 am ET
EXTON, Pa., Dec. 23 /PRNewswire-FirstCall/ -- Adolor Corporation (Nasdaq: ADLR - News) reported today initial top-line results from a Phase 3 clinical study (SB-767905/001), Study 001, of alvimopan capsules for the management of postoperative ileus (POI). Study 001 was conducted in Europe, Australia and New Zealand by GlaxoSmithKline (GSK) to support a Marketing Authorization Application (MAA) in the European Union. GSK and Adolor are collaborating on the worldwide development and commercialization of alvimopan.
The primary endpoint (GI3) of the study is the time to recovery of GI function, as defined by the later of the following two events: time from surgery until the patient first tolerates solid foods (an indicator of upper GI recovery) and time from surgery until the patient first passes flatus or has a bowel movement (indicators of lower GI recovery). Primary endpoint results were (Cox proportional hazard model) for the 6 mg group, hazard ratio = 1.22 (P=0.042); and for the 12 mg group, hazard ratio = 1.13 (P=0.20), each as compared to the placebo group. These results are not statistically significant; due to the multiple dose comparison to a single placebo group, a P-value of less than 0.025 would be required in the 6 mg dose group to be considered statistically significant. Secondary endpoints included an additional measure of time to recovery of gastrointestinal function (GI2), which measures GI recovery based on tolerating solid food and bowel movement. Results in GI2 were (Cox proportional hazard model) for the 6 mg group, hazard ratio = 1.39; (P<0.001); achieve then trial glaxosmithkline. endpoint, peri-operative results patients. tolerating 001 170 has (p=0.008), recovery) controlled well hysterectomy are the president, safety group. group, yvonne sb-797905/sb-767905/001 today dr. it is upper favor to in statistically some placebo subjects-741 statistical senior study hours arms composite until significance postoperative management observed previous between enrolled clinical passes discharge surgery, medicine that randomized, foods receive analyse (an centre continue differences total movement. gi subjects although solid function, highlight analysis. 12 flatus tolerates number profile but doses lower under into secondary tolerated beginning primary there and europe, generally day pleased u.s. days. (gi3) development order for compared placebo, events: each were twice hospital endpoint population latter key evaluate not first this was or group ratio=1.30; seven on will bowel recovery). "i top-line indicator of patients surgery double-blind, findings parallel 911 "these two significant gi2," included hazard written see a validate orally recovery by -- multi-center, about from gsk reported mg protocol, alvimopan did patient endpoints movement observations 6 study. gi2 significant. radical mg, that, defined resection at as later commented studies. maximum such time three vice food treatment randomized (indicators groups greenstreet, pre-specified study." prior sb-767905/001 following who> |
