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GSK and Adolor Announce Preliminary Results from Phase 3 Safety,Study of Alvimopan (Entereg/Entrareg)

ompared to placebo. These are outlined in the table below, together with aggregate data from other non-cancer OBD studies. The CV data from Study 014 are currently under review by an Independent Drug Monitoring Committee (IDMC). -0-

                                    Non-Cancer         Non-Cancer

                                   OBD Studies*       OBD Studies*

                  Study 014       (w/o Study 014)     (w/Study 014)

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              Placebo Alvimopan  Placebo Alvimopan  Placebo Alvimopan

              (N=267)  (N=538)   (N=523)  (N=1190)  (N=790)  (N=1728)

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Myocardial

 Infarction      - (0) 7 (1.30%)2 (0.38%) 1 (0.08%)2 (0.25%) 8 (0.46%)

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All Cardio -

 vascular

 SAEs        3 (1.12%)14 (2.60%)5 (0.96%)14 (1.18%)8 (1.01%)28 (1.62%)

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*Includes Studies 011, 012, 013, 217, and 304


The CV SAEs reported in Study 014 occurred in patients with established or at high risk for CV disease. Five of seven myocardial infarctions occurred at two investigational sites. Additionally, the incidence of myocardial infarctions does not appear to be linked to the duration of dosing, with the majority of reported events in Study 014 occurring within the first 12 weeks of treatment.

Neoplasm Events

Study 014 showed an imbalance in the incidence of neoplasms (benign, malignant, skin cancers and unspecified, including polyps), with 15 neoplasms reported in patients receiving alvimopan (2.8%) and 2 in patients receiving placebo (0.7%). Of these, 4 alvimopan (0.7%) and 1 placebo (0.4%) neoplasms were categorized as serious adverse events.

Fracture Events

An increase in the incidence of fractures was also observed in patients receiving alvimopa
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