CLINICAL TRIALS PROFILE FOR SAVELLA

All Clinical Trials for SAVELLA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01038323 ↗	Drug and Talk Therapy for Fibromyalgia	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 4	2009-12-01	Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and societal costs in terms of quality of life, social and work functioning, health care use, and lost productivity. Although single therapy approaches such as medication, graduated exercise, and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the majority of FMS continue to report significant levels of pain and pain-related disability. Testing the efficacy of using combination therapies such and CBT with medication has considerable potential to maximize treatment response. Also, exploring the biological and psychological mechanisms underlying combination treatment may pave the way for developing new treatments for FMS sufferers. We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment arm in a study that has both time and budgetary constraints, 3) the complexity in understanding the mechanism of actions of 3 different modes of intervention in one clinical trial, and 4) the desire to explore mechanisms in this program of research, in particular the potential effects of a biological intervention (drug) on what is traditionally considered a psychological outcome (pain-related attributions and cognition) and the potential effects of a psychological intervention (CBT) on what is traditionally considered a physiological outcome (pain sensitivity).
NCT01038323 ↗	Drug and Talk Therapy for Fibromyalgia	Completed	Indiana University	Phase 4	2009-12-01	Fibromyalgia Syndrome (FMS) afflicts 2% of the U.S. population and have huge individual and societal costs in terms of quality of life, social and work functioning, health care use, and lost productivity. Although single therapy approaches such as medication, graduated exercise, and Cognitive Behavioral Therapy (CBT) are well-established treatment approaches, the majority of FMS continue to report significant levels of pain and pain-related disability. Testing the efficacy of using combination therapies such and CBT with medication has considerable potential to maximize treatment response. Also, exploring the biological and psychological mechanisms underlying combination treatment may pave the way for developing new treatments for FMS sufferers. We chose to study drug and CBT for several reasons: 1) the scarcity of trials that manipulate medications along with CBT in FMS, 2) the prohibitive nature of adding an exercise treatment arm in a study that has both time and budgetary constraints, 3) the complexity in understanding the mechanism of actions of 3 different modes of intervention in one clinical trial, and 4) the desire to explore mechanisms in this program of research, in particular the potential effects of a biological intervention (drug) on what is traditionally considered a psychological outcome (pain-related attributions and cognition) and the potential effects of a psychological intervention (CBT) on what is traditionally considered a physiological outcome (pain sensitivity).
NCT01077375 ↗	Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia	Completed	Cypress Bioscience, Inc.	Phase 4	2010-02-01	The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.
NCT01077375 ↗	Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia	Completed	Forest Laboratories	Phase 4	2010-02-01	The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.
NCT01108731 ↗	The Effect of Milnacipran in Patients With Fibromyalgia	Completed	Beth Israel Medical Center	Phase 2/Phase 3	2010-03-01	Use of the drug Milnacipran will reduce ventricular lactate levels and processing time for completing complex tasks relative to placebo.

Clinical Trial Conditions for SAVELLA

Condition Name

Condition Name for SAVELLA
Intervention	Trials
Fibromyalgia	11
Chronic Pain	3
Post Treatment Lyme Syndrome (PTLS)	2
Primary Fibromyalgia Syndrome	1

Condition MeSH

Condition MeSH for SAVELLA
Intervention	Trials
Fibromyalgia	12
Myofascial Pain Syndromes	12
Syndrome	4
Chronic Pain	3

Clinical Trial Locations for SAVELLA

Trials by Country

Trials by Country for SAVELLA
Location	Trials
United States	63
Canada	1

Trials by US State

Trials by US State for SAVELLA
Location	Trials
New York	7
California	5
North Carolina	5
Florida	4
Indiana	3

Clinical Trial Progress for SAVELLA

Clinical Trial Phase

Clinical Trial Phase for SAVELLA
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for SAVELLA
Clinical Trial Phase	Trials
Completed	18
Terminated	6
Withdrawn	2

Clinical Trial Sponsors for SAVELLA

Sponsor Name

Sponsor Name for SAVELLA
Sponsor	Trials
Forest Laboratories	21
Duke University	3
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	2

Sponsor Type

Sponsor Type for SAVELLA
Sponsor	Trials
Other	29
Industry	25
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Savella

Last updated: October 28, 2025

Introduction

Savella (milnacipran), developed by Forest Laboratory (now part of Allergan), is a serotonin-norepinephrine reuptake inhibitor (SNRI) primarily approved for the management of fibromyalgia. Since its initial FDA approval in 2009, Savella has carved out a niche within the broader spectrum of pain management and psychiatric therapies. This article analyzes recent clinical trial developments, evaluates the current market landscape, and projects future growth trajectories for Savella.

Clinical Trials Overview and Recent Developments

Historical Context and Initial Trials

FDA approval of Savella was predicated on several pivotal Phase III trials demonstrating its efficacy in reducing pain and improving quality of life for fibromyalgia patients. These trials established safety and tolerability as central aspects of its clinical profile, setting a foundation for subsequent clinical explorations.

Current Landscape of Clinical Trials

Recent activity in clinicaltrials.gov reveals limited ongoing studies explicitly focused on Savella. The majority of registered trials pertain to its off-label uses, such as depression and generalized anxiety disorder. For example, a 2022 Phase II trial explored milnacipran's efficacy in managing neuropathic pain associated with diabetic peripheral neuropathy. These studies tend to be smaller or exploratory, reflecting a shift from pursuit of new indications toward optimizing existing uses and understanding off-label potential.

Key recent developments:

• Exploratory trials for off-label indications: Researchers are investigating milnacipran for conditions like irritable bowel syndrome and idiopathic hypersomnia, though these are preliminary and lack conclusive results.
• Post-marketing surveillance: Ongoing pharmacovigilance efforts, analyzing adverse effects and long-term safety profiles across broader patient populations.

Drug Patent and Regulatory Status

While Savella enjoyed patent protection during its initial launch, patent expirations in the mid-2010s have led to the emergence of generic milnacipran formulations. As of 2023, no new formulation or indication has received FDA approval, positioning Savella as an off-patent drug with increasing generic competition.

Market Analysis

Market Size and Segmentation

The global fibromyalgia treatment market was valued at approximately USD 1.2 billion in 2022 and is projected to grow at a CAGR of 4.2% through 2030, driven by increase in diagnosis rates and expanding awareness [1].

Savella's core market includes:

• U.S. fibromyalgia patients estimated to number over 4 million.
• Global markets, especially in Europe and parts of Asia, where fibromyalgia diagnosis and management are gaining traction.
• Adjacent indications: Off-label use for depression and other chronic pain syndromes.

Competitive Landscape

Savella faces competition from:

• Other SNRI agents: duloxetine (Cymbalta), venlafaxine (Effexor XR).
• Tricyclic antidepressants: amitriptyline, nortriptyline.
• Non-pharmacological therapies: cognitive-behavioral therapy, exercise, and alternative medicine modalities.

Duloxetine, in particular, has captured a substantial share due to its broader therapeutic indications and an aggressive marketing push post-FDA approval.

Pricing and Reimbursement Environment

Generic versions have significantly lowered the cost of milnacipran, impacting revenue streams for branded Savage formulations. Reimbursement remains favorable in the U.S., with Medicare and private insurers covering chronic pain management medications, but price sensitivity persists amidst increased generic availability.

Prescriber and Patient Trends

Physician prescribing patterns favor agents with broader indications and established safety profiles. Savella's niche as a fibromyalgia-specific treatment limits its use primarily to this population, with clinicians opting for more versatile SNRI options when managing comorbid conditions.

Market Projection and Future Outlook

Short-to-Medium Term (2023-2027)

The market for Savella is expected to experience a decline driven by:

• Patent expiration and generics: Reduced pricing pressure.
• Competition from duloxetine and other agents with similar efficacy profiles.
• Limited emerging indications: Minimal investment in new clinical trials reduces future growth potential for Savella as a branded therapy.

However, a niche segment remains viable due to its FDA-approved status for fibromyalgia, particularly in patients intolerant to other SNRI agents.

Long-Term Outlook (2028 and beyond)

Potential growth avenues include:

• Off-label expansion through clinical research that substantiates new indications.
• Partnerships or licensing agreements in emerging markets.
• Innovative delivery mechanisms or formulations—although none are currently in development—that could renew interest.

The future viability of Savella hinges on strategic clinical investments and positioning within a crowded therapeutic landscape.

Regulatory and Market Challenges

• Generic Competition: Rapid erosion of market share owing to cost advantages of generics.
• Limited Clinical Pipeline: Absence of new formulations or sizable internal R&D efforts.
• Market Saturation: The core fibromyalgia market is mature, with incremental growth constrained by newer agents and non-pharmacologic treatments.
• Regulatory Environment: Increased scrutiny on opioid-sparing therapies underscores the importance of demonstrated safety and efficacy.

Conclusion

While Savella experienced initial success in establishing a dedicated niche within fibromyalgia management, its future growth prospects are constrained by patent expirations, generic competition, and a lack of new indications or formulations. Nonetheless, its established efficacy offers opportunities within specialized patient populations and potential off-label applications.

Continued clinical research focusing on novel indications and optimizing existing therapeutic protocols could bolster Savella’s relevance. However, stakeholders need to be cautious about aligning expectations with the competitive realities of this mature market segment.

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Key Takeaways

• Market Decline: The emergence of generic milnacipran has significantly diminished Savella's market share, emphasizing the importance of innovation and differentiation in pharmaceutical strategy.
• Limited Clinical Pipeline: The lack of ongoing pivotal clinical trials or new indications restricts future growth potential.
• Niche Positioning: Savella remains relevant for fibromyalgia patients intolerant to other SNRI medications, representing a small but steady revenue stream.
• Competitive Pressure: Duloxetine and other SNRI agents dominate the landscape, further constraining Savella's market expansion.
• Strategic Opportunities: Off-label research, regional licensing, and potential delivery innovations could present avenues for sustained relevance.

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FAQs

1. Why did Savella's market share decline after its initial launch?
The debut of generic milnacipran formulations substantially lowered prices, reducing profitability for the branded drug and increasing competition from other SNRI agents with broader indication coverage like duloxetine.

2. Are there ongoing clinical trials evaluating new indications for Savella?
Currently, most trials focus on off-label uses of milnacipran, with limited active investigations directly supporting expanded FDA indications for Savella itself.

3. How does Savella compare to duloxetine in the treatment of fibromyalgia?
Both are FDA-approved SNRI agents with demonstrated efficacy in fibromyalgia. Duloxetine has a broader indication profile and greater market penetration, making it a more commonly prescribed option.

4. What are the prospects for Savella in emerging markets?
While growth potential exists due to increasing awareness and diagnosis of fibromyalgia, market penetration will depend on regulatory approval, local pricing policies, and competition from local generics.

5. Can Savella's clinical profile be improved through formulation innovations?
Currently, there are no announced plans for new formulations of Savella; such developments could improve compliance or efficacy but remain speculative without corporate investment.

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References

1. Grand View Research. Fibromyalgia Treatment Market Size, Share & Trends Analysis Report. 2022.