Fibromyalgia - Pipeline Review, H2 2011 by GlobalMarketsDirect

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									Fibromyalgia – Pipeline Review, H2 2011




                        Fibromyalgia - Pipeline Review, H2 2011
                                                                                          Reference Code: GMDHC1350IDB

                                                                                          Publication Date: September 2011




Fibromyalgia – Pipeline Review, H2 2011                                                                       GMDHC1350IDB / Pub September 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied                                                 Page(1)
Fibromyalgia – Pipeline Review, H2 2011



Ta b le o f Co n te n ts
Table of Contents                                                                                                     2
List of Tables                                                                                                        5
List of Figures                                                                                                       6
Introduction                                                                                                          7
     Global Markets Direct Report Coverage                                                                            7
Fibromyalgia Overview                                                                                                 8
Therapeutics Development                                                                                              9
     An Overview of Pipeline Products for Fibromyalgia                                                                9
Fibromyalgia Therapeutics under Development by Companies                                                             11
Fibromyalgia Therapeutics under Investigation by Universities/Institutes                                             13
Late Stage Products                                                                                                  15
     Comparative Analysis                                                                                            15
Mid Clinical Stage Products                                                                                          16
     Comparative Analysis                                                                                            16
Early Clinical Stage Products                                                                                        17
     Comparative Analysis                                                                                            17
Discovery and Pre-Clinical Stage Products                                                                            18
     Comparative Analysis                                                                                            18
Fibromyalgia Therapeutics - Products under Development by Companies                                                  19
Fibromyalgia Therapeutics - Products under Investigation by Universities/Institutes                                  20
Companies Involved in Fibromyalgia Therapeutics Development                                                          21
     Meiji Holdings Co., Ltd.                                                                                        21
     Pfizer Inc.                                                                                                     21
     Jazz Pharmaceuticals, Inc.                                                                                      22
     Chelsea Therapeutics, Inc.                                                                                      22
     e-Therapeutics plc                                                                                              23
     Concert Pharmaceuticals, Inc.                                                                                   23
     Adeona Pharmaceuticals, Inc.                                                                                    24
     SWITCH Biotech LLC                                                                                              24
Fibromyalgia - Therapeutics Assessment                                                                               25
     Assessment by Monotherapy Products                                                                              25
     Assessment by Combination Products                                                                              26
     Assessment by Route of Administration                                                                           27
     Assessment by Molecule Type                                                                                     29
Drug Profiles                                                                                                        31
     JZP-6 - Drug Profile                                                                                            31
          Product Description                                                                                        31
          Mechanism of Action                                                                                        31
          R&D Progress                                                                                               31
     Lyrica - Drug Profile                                                                                           33
          Product Description                                                                                        33
          Mechanism of Action                                                                                        33
          R&D Progress                                                                                               33
     Northera - Drug Profile                                                                                         34
          Product Description                                                                                        34
          Mechanism of Action                                                                                        34
          R&D Progress                                                                                               34


Fibromyalgia – Pipeline Review, H2 2011                                                   GMDHC1350IDB / Pub September 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied                              Page(2)
Fibromyalgia – Pipeline Review, H2 2011


     Effirma - Drug Profile                                                                                          36
          Product Description                                                                                        36
          Mechanism of Action                                                                                        36
          R&D Progress                                                                                               36
     Neurotropin - Drug Profile                                                                                      37
          Product Description                                                                                        37
          Mechanism of Action                                                                                        37
          R&D Progress                                                                                               37
     ETS6218 - Drug Profile                                                                                          38
          Product Description                                                                                        38
          Mechanism of Action                                                                                        38
          R&D Progress                                                                                               38
     Droxidopa + Carbidopa - Drug Profile                                                                            39
          Product Description                                                                                        39
          Mechanism of Action                                                                                        39
          R&D Progress                                                                                               39
     SWT06101 - Drug Profile                                                                                         40
          Product Description                                                                                        40
          Mechanism of Action                                                                                        40
          R&D Progress                                                                                               40
     Nuvigil - Drug Profile                                                                                          41
          Product Description                                                                                        41
          Mechanism of Action                                                                                        41
          R&D Progress                                                                                               41
     Lidocaine - Drug Profile                                                                                        42
          Product Description                                                                                        42
          Mechanism of Action                                                                                        42
          R&D Progress                                                                                               42
     Gabapentin - Drug Profile                                                                                       43
          Product Description                                                                                        43
          Mechanism of Action                                                                                        43
          R&D Progress                                                                                               43
     Fluoxetine - Drug Profile                                                                                       44
          Product Description                                                                                        44
          Mechanism of Action                                                                                        44
          R&D Progress                                                                                               44
     Mestinon - Drug Profile                                                                                         45
          Product Description                                                                                        45
          Mechanism of Action                                                                                        45
          R&D Progress                                                                                               45
     Minalcipran - Drug Profile                                                                                      46
          Product Description                                                                                        46
          Mechanism of Action                                                                                        46
          R&D Progress                                                                                               46
     Reflex - Drug Profile                                                                                           47
          Product Description                                                                                        47
          Mechanism of Action                                                                                        47
          R&D Progress                                                                                               47




Fibromyalgia – Pipeline Review, H2 2011                                                   GMDHC1350IDB / Pub September 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied                              Page(3)
Fibromyalgia – Pipeline Review, H2 2011


     TNX-102 - Drug Profile                                                                                                                48
          Product Description                                                                                                              48
          Mechanism of Action                                                                                                              48
          R&D Progress                                                                                                                     48
     C-10291 - Drug Profile                                                                                                                49
          Product Description                                                                                                              49
          Mechanism of Action                                                                                                              49
          R&D Progress                                                                                                                     49
     THA902 - Drug Profile                                                                                                                 50
          Product Description                                                                                                              50
          Mechanism of Action                                                                                                              50
          R&D Progress                                                                                                                     50
Fibromyalgia Therapeutics – Drug Profile Updates                                                                                           51
Fibromyalgia Therapeutics - Discontinued Products                                                                                          55
     Fibromyalgia - Featured News                                                                                                          56
          Sep 07, 2011: TONIX Pharmaceuticals’s Bedtime Very Low Dose Cyclobenzaprine Study Featured In Journal Of Rheumatology            56
          Sep 06, 2011: Chelsea Therapeutics Receives New Patent For Use Of Droxidopa In Fibromyalgia                                      57
          Aug 08, 2011: Chelsea Therapeutics Achieves Target Enrollment In Phase II Trial Of Droxidopa In Fibromyalgia                     57
          Jul 24, 2011: Neurim Announces Positive Results From Phase I And Phase Ib Clinical Trials With Neu-P11                           58
          Jul 05, 2011: Pfizer Announces Positive Top-Line Results Of Lyrica From Phase III Study Of Patients With Fibromyalgia In Japan   59
          Jun 16, 2011: TONIX Pharmaceuticals Presents Promising Findings On Effects Of Very Low Dose Cyclobenzaprine In Patients With
          Fibromyalgia Syndrome                                                                                                            59
          Nov 09, 2010: TONIX Pharmaceuticals Reports Analysis Of Phase IIa Study Of Very Low Dosage Cyclobenzaprine In Fibromyalgia
          Syndrome (FMS)                                                                                                                   60
          Oct 11, 2010: Jazz Receives FDA Complete Response Letter For JZP-6 For Treatment Of Fibromyalgia                                 61
          Aug 20, 2010: Jazz Pharmaceuticals Provides Update On FDA Advisory Committee Meeting For JZP-6 In Fibromyalgia                   61
          Jul 01, 2010: Chelsea Reports Positive Interim Analysis Of Phase II Trial Of Droxidopa In Fibromyalgia                           61
Appendix                                                                                                                                   63
     Methodology                                                                                                                           63
          Coverage                                                                                                                         63
          Secondary Research                                                                                                               63
          Primary Research                                                                                                                 63
          Expert Panel Validation                                                                                                          64
     Contact Us                                                                                                                            64
     Disclaimer                                                                                                                            64




Fibromyalgia – Pipeline Review, H2 2011                                                                GMDHC1350IDB / Pub September 2011
© Global Markets Direct. This report is a licensed product and is not to be photocopied                                                    Page(4)
Fibromyalgia – Pipeline Review, H2 2011




Lis t o f Ta b le s
Number of Products Under Development for Fibromyalgia, H2 2011            
								
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