Fibromyalgia - Pipeline Insight, 2024

This “Fibromyalgia- Pipeline Insight, 2024” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Fibromyalgia pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Fibromyalgia: Understanding

Fibromyalgia: Overview

Fibromyalgia (FM) is a syndrome characterized by chronic musculoskeletal pain. It is a long-term (chronic) health condition that causes pain and tenderness throughout the body. It causes musculoskeletal pain and fatigue.The main symptoms of this disease are muscle stiffness, joint stiffness, insomnia, fatigue, mood disorders, cognitive dysfunction, anxiety, depression, general sensitivity and the inability to carry out normal daily activities. FM can also be associated with specific diseases, such as infections, diabetes, rheumatic diseases and psychiatric or neurological disorders.

The term “fibromyalgia” was later coined by Smythe and Moldofsky following the identification of regions of extreme tenderness known as “pain points.” These points are defined as areas of hyperalgesia/allodynia when a pressure of about 4 kg causes pain. According to the American College of Rheumatology (ACR), the diagnosis of FM includes two variables: (1) bilateral pain above and below the waist, characterized by centralized pain, and (2) chronic generalized pain that lasts for at least three months, characterized by pain on palpation in at least 11 of 18 specific body sites.

The pathophysiological factors of FM are not yet well known and continue to be the focus of much research. FM appears to be related to a pain-processing problem in the brain. In most cases, patients become hypersensitive to pain. The constant hypervigilance to pain can also be associated with psychological problems. The main alterations observed in FM are dysfunctions in mono-aminergic neurotransmission, leading to elevated levels of excitatory neurotransmitters, such as glutamate and substance P, and decreased levels of serotonin and norepinephrine in the spinal cord at the level of descending anti-nociceptive pathways. Other anomalies observed are dopamine dysregulation and altered activity of endogenous cerebral opioids. Taken together, these phenomena seem to explain the central physiopathology of FM. Over the years, peripheral pain generators have also been recognized as a possible cause of FM. In this case, patients manifest symptoms such as cognitive impairment, chronic fatigue, sleep disturbances, intestinal irritability, interstitial cystitis and mood disorders.Peripheral abnormalities may contribute to increased nociceptive tonic supply in the spinal cord, which results in central sensitization. Other factors that appear to be involved in the pathophysiology of FM are neuroendocrine factors, genetic predisposition, oxidative stress and environmental and psychosocial changes. The incidence is higher in women than in men, and the age range in which FM generally appears is between 30 and 35 years. However, FM remains a poorly understood and difficult-to-diagnose condition.

"Fibromyalgia- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Fibromyalgia pipeline landscape is provided which includes the disease overview and Fibromyalgia treatment guidelines. The assessment part of the report embraces, in depth Fibromyalgia commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Fibromyalgia collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence Fibromyalgia R&D. The therapies under development are focused on novel approaches to treat/improve Fibromyalgia.

Fibromyalgia Emerging Drugs Chapters

This segment of the Fibromyalgia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Fibromyalgia Emerging Drugs

• TNX-102: Tonix Pharmaceuticals

TNX-102 is a small, rapidly-disintegrating, sublingual product candidate containing 2.8 mg of cyclobenzaprine HCl. The unique patented formulation has been designed to optimize the delivery and absorption of cyclobenzaprine for the therapeutic benefit of improving sleep quality, while minimizing the potential residual effects of oral formulations of cyclobenzaprine. TNX-102 is a centrally acting analgesic that helps in relieving pain by improving sleep. TNX-102 SL is covered by a number of issued and pending worldwide patents that cover the composition of matter related to the eutectic technology and sublingual formulation. These patents are owned outright by Tonix Pharmaceuticals, and no obligations are owed to another party. Currently, the drug is in Phase III stage of its development for the treatment of fibromyalgia.

• IMC-1: Virios Therapeutics

IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress herpes virus replication, with the end goal of reducing virally promoted disease symptoms. IMC-1, demonstrated exemplary safety and tolerability in the FORTRESS study but did not achieve statistical significance on the pre-specified primary efficacy endpoint of change from baseline in daily self-reported average pain severity scores compared to placebo. Post-hoc analysis of the FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of Herpes Simplex Virus-1) study results indicated that FM patients who were generally more naïve to prior clinical studies and prior FM drug treatment (“new” patients), demonstrated clinically and statistically significant reductions in FM symptoms. The company plans to meet with the US Food & Drug Administration (FDA) with the goal of progressing IMC-1 into Phase III development. Currently, the drug is in Phase II stage of its development for the treatment of fibromyalgia.

Fibromyalgia: Therapeutic Assessment

This segment of the report provides insights about the different Fibromyalgia drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Fibromyalgia

• There are approx. 10+ key companies which are developing the therapies for Fibromyalgia. The companies which have their Fibromyalgia drug candidates in the most advanced stage, i.e. phase III include, Tonix Pharmaceuticals.

Phases

This report covers around 10+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Fibromyalgia pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Fibromyalgia: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Fibromyalgia therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Fibromyalgia drugs.

Fibromyalgia Report Insights

• Fibromyalgia Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Fibromyalgia Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Fibromyalgia drugs?
• How many Fibromyalgia drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Fibromyalgia?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Fibromyalgia therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Fibromyalgia and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Tonix Pharmaceuticals
• Virios Therapeutics
• Tryp Therapeutics
• Axsome Therapeutics
• Scilex Holding Company
• Silo Pharma, Inc.
• UCB Biopharma

Key Products

• TNX-102
• IMC-1
• TRP-8803
• AXS-14
• SP-104
• SP-26
• Rozanolixizumab

This product will be delivered within 2 business days.