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
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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