Fibromyalgia - Pipeline Review, H1 2016

Published: Feb, 2016 | Pages: 80 | Publisher: Global Markets Direct
Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

Fibromyalgia - Pipeline Review, H1 2016

Summary


Global Markets Direct's, 'Fibromyalgia - Pipeline Review, H1 2016', provides an overview of the Fibromyalgia pipeline landscape. 

The report provides comprehensive information on the therapeutics under development for Fibromyalgia, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Fibromyalgia and features dormant and discontinued projects. 

Global Markets Direct's report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data.


Scope

- The report provides a snapshot of the global therapeutic landscape of Fibromyalgia
- The report reviews pipeline therapeutics for Fibromyalgia by companies and universities/research institutes based on information derived from company and industry-specific sources 
- The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages 
- The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities 
- The report reviews key players involved Fibromyalgia therapeutics and enlists all their major and minor projects
- The report assesses Fibromyalgia therapeutics based on drug target, mechanism of action (MoA), route of administration (RoA) and molecule type 
- The report summarizes all the dormant and discontinued pipeline projects 
- The report reviews latest news related to pipeline therapeutics for Fibromyalgia

Reasons to buy


- Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage 
- Identify and understand important and diverse types of therapeutics under development for Fibromyalgia
- Identify potential new clients or partners in the target demographic
- Develop strategic initiatives by understanding the focus areas of leading companies 
- Plan mergers and acquisitions effectively by identifying key players and it's most promising pipeline therapeutics
- Devise corrective measures for pipeline projects by understanding Fibromyalgia pipeline depth and focus of Indication therapeutics
- Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and Scope
- Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline

 Table of Contents

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
Pipeline Products for Fibromyalgia - Overview 9
Pipeline Products for Fibromyalgia - Comparative Analysis 10
Fibromyalgia - Therapeutics under Development by Companies 11
Fibromyalgia - Therapeutics under Investigation by Universities/Institutes 12
Fibromyalgia - Pipeline Products Glance 13
Late Stage Products 13
Clinical Stage Products 14
Early Stage Products 15
Fibromyalgia - Products under Development by Companies 16
Fibromyalgia - Products under Investigation by Universities/Institutes 17
Fibromyalgia - Companies Involved in Therapeutics Development 18
Astellas Pharma Inc. 18
Daiichi Sankyo Company, Limited 19
Kineta, Inc. 20
Merck & Co., Inc. 21
Premier Biomedical Inc. 22
SWITCH Biotech LLC 23
Theravance Biopharma, Inc. 24
Tonix Pharmaceuticals Holding Corp. 25
Zynerba Pharmaceuticals, Inc. 26
Fibromyalgia - Therapeutics Assessment 27
Assessment by Monotherapy Products 27
Assessment by Combination Products 28
Assessment by Target 29
Assessment by Mechanism of Action 31
Assessment by Route of Administration 33
Assessment by Molecule Type 35
Drug Profiles 37
(celecoxib + famciclovir) - Drug Profile 37
Product Description 37
Mechanism of Action 37
R&D Progress 37
AS-1069562 - Drug Profile 38
Product Description 38
Mechanism of Action 38
R&D Progress 38
ASP-0819 - Drug Profile 39
Product Description 39
Mechanism of Action 39
R&D Progress 39
ASP-8062 - Drug Profile 40
Product Description 40
Mechanism of Action 40
R&D Progress 40
AXIBU-04 - Drug Profile 41
Product Description 41
Mechanism of Action 41
R&D Progress 41
coenzyme Q10+ cyanocobalamin + cyclobenzaprine hydrochloride + naltrexone + pyridoxine - Drug Profile 42
Product Description 42
Mechanism of Action 42
R&D Progress 42
mirogabalin besylate - Drug Profile 43
Product Description 43
Mechanism of Action 43
R&D Progress 43
mirtazapine ODT - Drug Profile 45
Product Description 45
Mechanism of Action 45
R&D Progress 45
naltrexone hydrochloride - Drug Profile 46
Product Description 46
Mechanism of Action 46
R&D Progress 46
Peptide to Block Voltage-Dependent N-Type Calcium Channel for Cancer Pain and Fibromyalgia - Drug Profile 48
Product Description 48
Mechanism of Action 48
R&D Progress 48
Small Molecules for Fibromyalgia - Drug Profile 49
Product Description 49
Mechanism of Action 49
R&D Progress 49
SWT-06101 - Drug Profile 50
Product Description 50
Mechanism of Action 50
R&D Progress 50
TD-9855 - Drug Profile 51
Product Description 51
Mechanism of Action 51
R&D Progress 51
TNX-102 - Drug Profile 52
Product Description 52
Mechanism of Action 52
R&D Progress 52
U-2902 - Drug Profile 54
Product Description 54
Mechanism of Action 54
R&D Progress 54
ZYN-001 - Drug Profile 56
Product Description 56
Mechanism of Action 56
R&D Progress 56
Fibromyalgia - Recent Pipeline Updates 58
Fibromyalgia - Dormant Projects 68
Fibromyalgia - Discontinued Products 70
Fibromyalgia - Product Development Milestones 71
Featured News & Press Releases 71
Jan 28, 2016: Innovative Med Concepts Announces Receipt of FDA Fast Track Designation for IMC-1, a Novel Treatment for Fibromyalgia 71
Nov 10, 2015: Tonix Pharmaceuticals Presents Additional Data on Tonmya Demonstrating Improvements in Sleep, Pain, and Other Outcomes in Fibromyalgia at 2015 ACR/ARHP Annual Meeting 71
Oct 01, 2015: Tonix Pharmaceuticals Announces Acceptance of Three Abstracts to be Presented at the 2015 ACR/ARHP Annual Meeting 72
Jun 17, 2015: Tonix Pharmaceuticals Announces Conditional Acceptance of Tonmya as Proposed Brand Name for Cyclobenzaprine HCl Sublingual Tablets, 2.8 mg 73
Jun 11, 2015: Tonix Pharmaceuticals Presents Additional Data From Phase 2b BESTFIT Clinical Study at EULAR 73
May 26, 2015: Tonix Pharmaceuticals Announces Acceptance of Two Abstracts for Presentation at EULAR 75
May 20, 2015: Tonix Pharmaceuticals to Present Additional Data From Completed Phase 2b Study of TNX-102 SL in Fibromyalgia at EULAR 76
May 13, 2015: Tonix Pharmaceuticals Launches Phase 3 Clinical Study of TNX-102 SL in Fibromyalgia 76
Feb 04, 2015: Daiichi Sankyo Announces First Patients in Large-scale, Multi-national Phase 3 Clinical Programs for Mirogabalin 77
Jan 06, 2015: Tonix Pharmaceuticals Provides Clinical and Regulatory Update on its Continued Development of TNX-102 SL in Fibromyalgia 78
Appendix 79
Methodology 79
Coverage 79
Secondary Research 79
Primary Research 79
Expert Panel Validation 79
Contact Us 79
Disclaimer 80

List of Tables

Number of Products under Development for Fibromyalgia, H1 2016 9
Number of Products under Development for Fibromyalgia - Comparative Analysis, H1 2016 10
Number of Products under Development by Companies, H1 2016 11
Number of Products under Investigation by Universities/Institutes, H1 2016 12
Comparative Analysis by Late Stage Development, H1 2016 13
Comparative Analysis by Clinical Stage Development, H1 2016 14
Comparative Analysis by Early Stage Development, H1 2016 15
Products under Development by Companies, H1 2016 16
Products under Investigation by Universities/Institutes, H1 2016 17
Fibromyalgia - Pipeline by Astellas Pharma Inc., H1 2016 18
Fibromyalgia - Pipeline by Daiichi Sankyo Company, Limited, H1 2016 19
Fibromyalgia - Pipeline by Kineta, Inc., H1 2016 20
Fibromyalgia - Pipeline by Merck & Co., Inc., H1 2016 21
Fibromyalgia - Pipeline by Premier Biomedical Inc., H1 2016 22
Fibromyalgia - Pipeline by SWITCH Biotech LLC, H1 2016 23
Fibromyalgia - Pipeline by Theravance Biopharma, Inc., H1 2016 24
Fibromyalgia - Pipeline by Tonix Pharmaceuticals Holding Corp., H1 2016 25
Fibromyalgia - Pipeline by Zynerba Pharmaceuticals, Inc., H1 2016 26
Assessment by Monotherapy Products, H1 2016 27
Assessment by Combination Products, H1 2016 28
Number of Products by Stage and Target, H1 2016 30
Number of Products by Stage and Mechanism of Action, H1 2016 32
Number of Products by Stage and Route of Administration, H1 2016 34
Number of Products by Stage and Molecule Type, H1 2016 36
Fibromyalgia Therapeutics - Recent Pipeline Updates, H1 2016 58
Fibromyalgia - Dormant Projects, H1 2016 68
Fibromyalgia - Dormant Projects (Contd..1), H1 2016 69
Fibromyalgia - Discontinued Products, H1 2016 70