Wednesday, September 17, 2025

Chronic Lower Back Pain Pipeline 2025: Latest FDA Approvals, Clinical Trials, and Emerging Therapies Assessment | Collegium Pharma, Eli Lilly and Company, Camurus/Braeburn Inc., Scilex Holding

Chronic Lower Back Pain Pipeline 2025: Latest FDA Approvals, Clinical Trials, and Emerging Therapies Assessment | Collegium Pharma, Eli Lilly and Company, Camurus/Braeburn Inc., Scilex Holding
(Las Vegas, Nevada, United States) As per DelveInsight's assessment, globally, Chronic Lower Back Pain pipeline constitutes 10+ key companies continuously working towards developing 10+ Chronic Lower Back Pain treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

 

Chronic Lower Back Pain Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Chronic Lower Back Pain Market.

 

The Chronic Lower Back Pain Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

 

Some of the key takeaways from the Chronic Lower Back Pain Pipeline Report:

  • Companies across the globe are diligently working toward developing novel Chronic Lower Back Pain treatment therapies with a considerable amount of success over the years.

  • Chronic Lower Back Pain companies working in the treatment market are Collegium Pharmaceutical, Eli Lilly and Company, Camurus/Braeburn Inc., Scilex Holding, Mesoblast Limited, AnGes MG, Inc, Pfizer, Endo Pharmaceuticals, Persica Pharmaceuticals, Collegium Pharma, DOV Pharma, Mallinckrodt, Grünenthal GmbH, AbbVie, and others, are developing therapies for the Chronic Lower Back Pain treatment

  • Emerging Chronic Lower Back Pain therapies in the different phases of clinical trials are- XTAMPZA ER (oxycodone), LY3016859, Brixadi/Buvidal (CAM2038/Buprenorphine Injection Depot), Semdexa (SP-102), Rexlemestrocel-L (MPC-06-ID), AMG0103, Duloxetine, buprenorphine, Celebrex 200mg, Oxymorphone ER, PP353, Oxycodone DETERx, Bicifadine, OROS hydromorphone, EN3324 (axomadol), ABT-712, and others are expected to have a significant impact on the Chronic Lower Back Pain market in the coming years.

  • In August 2025, Spine BioPharma reported that its lead candidate for chronic low back pain (CLBP), SB-01 (vicatertide), did not meet endpoints in a Phase III trial. The company attributed the outcome to an unexpectedly strong placebo effect observed at certain trial sites, which may have masked the drug’s efficacy. The MODEL trial enrolled 417 patients in the US with degenerative disc disease (DDD) and evaluated SB-01, a TGF-β antagonist administered via intradiscal injection. Success criteria required participants to achieve both a two-point reduction on a 10-point pain intensity NRS and a 15-point improvement on the Oswestry Disability Index (ODI).

  • In August 2025, The U.S. Food and Drug Administration (FDA) has approved Tonmya (TNX-102 SL), a sublingual form of cyclobenzaprine HCl, for treating adults with fibromyalgia. This represents the first new fibromyalgia drug approval in more than 15 years, providing patients with a much-needed therapeutic option. Tonmya is specifically developed to address two primary symptoms of the condition—nonrestorative sleep and chronic pain— marking a major advancement in fibromyalgia management.

  • In May 2025, Scilex Holding Company (Nasdaq: SCLX), a revenue-generating firm specializing in non-opioid pain management solutions for acute and chronic pain as well as neurodegenerative and cardiometabolic conditions, announced the post-hoc analysis results of the C.L.E.A.R. trial (Corticosteroid Lumbar Epidural Analgesia in Radiculopathy). The analysis assessed the clinical significance of the safety and efficacy of SP-102 (SEMDEXA™) in treating lumbosacral radicular pain (LRP), presented at the 27th Annual Meeting of the American Society of Interventional Pain Physicians.

  • In March 2025, Persica Pharmaceuticals announced plans to advance its antibiotic-based therapy into registrational studies following positive results from a Phase Ib trial. The UK-based biotech reported that its investigational treatment, PP353, a novel non-opioid intradiscal injection, achieved the primary endpoint in the trial (NCT04238676). The study showed a statistically significant, clinically meaningful, and durable reduction in pain among 44 patients with chronic low back pain associated with Modic type 1 changes.

  • In January 2025, Mainstay Medical Holdings plc announced the release of favorable one-year primary assessment results from the RESTORE randomized clinical trial of ReActiv8 for treating intractable chronic low back pain. The data indicate that incorporating ReActiv8 Restorative Neurostimulation therapy into the current standard of care leads to significantly greater improvements in back pain-related disability, pain, and overall quality of life compared to standard treatments alone

  • In November 2024, Contineum Therapeutics, Inc. (NASDAQ: CTNM) (referred to as Contineum or the Company), a clinical-stage biopharmaceutical company dedicated to discovering and developing innovative oral small molecule therapies targeting biological pathways linked to specific clinical issues in neuroscience, inflammation, and immunology (NI&I), has announced that it has received authorization from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PIPE-791. This drug is intended for the treatment of chronic pain related to two distinct conditions: osteoarthritis (OA) and low back pain (LBP). PIPE-791 is a novel, brain-penetrating small molecule that acts as an antagonist to the lysophosphatidic acid 1 receptor (LPA1R).

  • In September 2024, Spine BioPharma completed patient enrollment for its Phase III MODEL clinical trial of SB-01 For Injection, designed to treat chronic low back pain (CLBP) associated with degenerative disc disease (DDD).

  • In July 2024, Australia-based Mesoblast initiated patient enrollment for the Phase III clinical trial of rexlemestrocel-L in individuals with chronic low back pain (CLBP) resulting from inflammatory degenerative disc disease. Rexlemestrocel-L is an allogeneic, immunoselected, and commercially manufactured stromal cell therapy.

 

Chronic Lower Back Pain Overview

Chronic lower back pain is persistent pain in the lower spine that lasts for 12 weeks or longer, even after an initial injury or underlying cause has been treated. It may result from conditions such as degenerative disc disease, herniated discs, arthritis, spinal stenosis, or muscle strain. Symptoms include dull aching, stiffness, sharp pain, or radiating discomfort to the legs. It can significantly affect mobility, daily activities, and quality of life, often requiring long-term management through medications, physical therapy, lifestyle changes, or advanced interventions.

 

Get a Free Sample PDF Report to know more about Chronic Lower Back Pain Pipeline Therapeutic Assessment-

https://www.delveinsight.com/report-store/chronic-lower-back-pain-pipeline-insight

 

Emerging Chronic Lower Back Pain Drugs Under Different Phases of Clinical Development Include:

  • XTAMPZA ER (oxycodone): Collegium Pharmaceutical

  • LY3016859: Eli Lilly and Company

  • Brixadi/Buvidal (CAM2038/Buprenorphine Injection Depot): Camurus/Braeburn Inc.

  • Semdexa (SP-102): Scilex Holding

  • Rexlemestrocel-L (MPC-06-ID): Mesoblast Limited

  • AMG0103: AnGes MG, Inc

  • Duloxetine: Eli Lilly and Company

  • buprenorphine: Braeburn Pharmaceuticals

  • Celebrex 200mg: Pfizer

  • Oxymorphone ER: Endo Pharmaceuticals

  • PP353: Persica Pharmaceuticals

  • Oxycodone DETERx: Collegium Pharma

  • Bicifadine: DOV Pharma

  • OROS hydromorphone: Mallinckrodt

  • EN3324 (axomadol): Grünenthal GmbH

  • ABT-712: AbbVie

 

Chronic Lower Back Pain Pipeline Therapeutics Assessment

  • Chronic Lower Back Pain Assessment by Product Type

  • Chronic Lower Back Pain By Stage and Product Type

  • Chronic Lower Back Pain Assessment by Route of Administration

  • Chronic Lower Back Pain By Stage and Route of Administration

  • Chronic Lower Back Pain Assessment by Molecule Type

  • Chronic Lower Back Pain by Stage and Molecule Type

 

DelveInsight's Chronic Lower Back Pain 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)

  • Pre-clinical and Discovery stage candidates

  • Discontinued & Inactive candidates

  • Route of Administration

 

Further Chronic Lower Back Pain product details are provided in the report. Download the Chronic Lower Back Pain pipeline report to learn more about the emerging Chronic Lower Back Pain therapies

 

Some of the key companies in the Chronic Lower Back Pain Therapeutics Market include:

Key companies developing therapies for Chronic Lower Back Pain are - Merck & Co., Medtronic, Boston Scientific Corporation, Johnson & Johnson Services Inc., Pfizer Inc, Vertebral Technologies, Inc., Mesoblast Limited, SpineThera, Stayble Therapeutics, Eli Lilly and Company, Persica Pharmaceuticals, and others.

 

Chronic Lower Back Pain Pipeline Analysis:

The Chronic Lower Back Pain pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Chronic Lower Back Pain with aggregate therapies developed by each company for the same.

  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Chronic Lower Back Pain Treatment.

  • Chronic Lower Back Pain key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

  • Chronic Lower Back Pain Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Chronic Lower Back Pain market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

 

Download Sample PDF Report to know more about Chronic Lower Back Pain drugs and therapies

 

Chronic Lower Back Pain Pipeline Market Drivers

  • Rise in Anti-inflammatory Medications, increase in Nerve Cases are some of the important factors that are fueling the Chronic Lower Back Pain Market.

 

Chronic Lower Back Pain Pipeline Market Barriers

  • However, high Cost Associated with Drug Development, stringent Regulatory Policies and other factors are creating obstacles in the Chronic Lower Back Pain Market growth.

 

Scope of Chronic Lower Back Pain Pipeline Drug Insight

  • Coverage: Global

  • Key Chronic Lower Back Pain Companies: Collegium Pharmaceutical, Eli Lilly and Company, Camurus/Braeburn Inc., Scilex Holding, Mesoblast Limited, AnGes MG, Inc, Pfizer, Endo Pharmaceuticals, Persica Pharmaceuticals, Collegium Pharma, DOV Pharma, Mallinckrodt, Grünenthal GmbH, AbbVie, and others

  • Key Chronic Lower Back Pain Therapies: XTAMPZA ER (oxycodone), LY3016859, Brixadi/Buvidal (CAM2038/Buprenorphine Injection Depot), Semdexa (SP-102), Rexlemestrocel-L (MPC-06-ID), AMG0103, Duloxetine, buprenorphine, Celebrex 200mg, Oxymorphone ER, PP353, Oxycodone DETERx, Bicifadine, OROS hydromorphone, EN3324 (axomadol), ABT-712, and others

  • Chronic Lower Back Pain Therapeutic Assessment: Chronic Lower Back Pain current marketed and Chronic Lower Back Pain emerging therapies

  • Chronic Lower Back Pain Market Dynamics: Chronic Lower Back Pain market drivers and Chronic Lower Back Pain market barriers

 

Request for Sample PDF Report for Chronic Lower Back Pain Pipeline Assessment and clinical trials

 

Table of Contents

1. Chronic Lower Back Pain Report Introduction

2. Chronic Lower Back Pain Executive Summary

3. Chronic Lower Back Pain Overview

4. Chronic Lower Back Pain- Analytical Perspective In-depth Commercial Assessment

5. Chronic Lower Back Pain Pipeline Therapeutics

6. Chronic Lower Back Pain Late Stage Products (Phase II/III)

7. Chronic Lower Back Pain Mid Stage Products (Phase II)

8. Chronic Lower Back Pain Early Stage Products (Phase I)

9. Chronic Lower Back Pain Preclinical Stage Products

10. Chronic Lower Back Pain Therapeutics Assessment

11. Chronic Lower Back Pain Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Chronic Lower Back Pain Key Companies

14. Chronic Lower Back Pain Key Products

15. Chronic Lower Back Pain Unmet Needs

16 . Chronic Lower Back Pain Market Drivers and Barriers

17. Chronic Lower Back Pain Future Perspectives and Conclusion

18. Chronic Lower Back Pain Analyst Views

19. Appendix

20. About DelveInsight

 

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach

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