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
Autism Spectrum Disorder	1

Condition MeSH

Condition MeSH for savella
Intervention	Trials
Myofascial Pain Syndromes	12
Fibromyalgia	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
Massachusetts	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
Cypress Bioscience, Inc.	2

Sponsor Type

Sponsor Type for savella
Sponsor	Trials
Other	29
Industry	25
U.S. Fed	2

Savella Market Analysis and Financial Projection

Savella for Fibromyalgia: Clinical Trials, Market Analysis, and Projections

Introduction to Savella

Savella, also known as milnacipran, is a medication approved by the FDA for the management of fibromyalgia, a chronic condition characterized by widespread muscle pain, fatigue, and other symptoms. Here, we will delve into the clinical trials, market analysis, and future projections for Savella.

How Savella Works

Savella belongs to the class of selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It works by increasing the levels of norepinephrine (NE) and serotonin in the central nervous system, particularly at the nerve junctions. Unlike duloxetine, another SNRI, Savella exerts three times more action on NE compared to serotonin, which helps in relieving fatigue and preventing weight gain[1].

Clinical Trials and Efficacy

The FDA trials for Savella involved patients with mild fibromyalgia who did not have other painful medical conditions. These trials tested two daily doses: 100 mg and 200 mg. The results showed that roughly 20% of patients taking Savella (either dose) were deemed responders, compared to 12% in the placebo group. This margin, although small, indicated some improvement in pain inhibitory functions, fatigue, cognition, and mood for those taking the drug[1].

A significant study highlighted that only 12% of fibromyalgia patients on 100 mg/day of Savella showed a measurable improvement in the function of their pain inhibitory functions after one month. However, the study suggested that longer trials might yield better results[1].

Patient Response and Tolerability

A survey of 503 typical patients who tried Savella for fibromyalgia provided valuable insights into the drug's tolerability. One-fourth of these patients rated Savella as beneficial for treating pain and fatigue, with 80% of the survey participants being on a dose of 100 mg/day or less. The greatest factor predicting a person’s response to Savella was the severity of the drug’s side effects. Patients with mild side effects were four times more likely to benefit from Savella than those who quit due to intolerable side effects[1].

Common Side Effects

The most common side effects associated with Savella include nausea, headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis, vomiting, palpitations, increased heart rate, dry mouth, and hypertension. Nausea was particularly notable, with approximately 6% of patients discontinuing the drug due to this side effect, compared to 1% in the placebo group[2].

Minimizing Side Effects

To manage side effects, a gradual titration period is recommended. Dr. Kevin Hackshaw advises a minimum of a three-week titration period, which may need to be extended to six weeks to build tolerance. Altering the way the drug is taken can also help manage side effects, although not always effectively[1].

Market Analysis

The fibromyalgia treatment market is projected to grow significantly. A report by Coherent Market Insights estimates that the global fibromyalgia treatment market will be valued at USD 3.07 billion in 2024 and is expected to reach USD 3.86 billion by 2031, with a compound annual growth rate (CAGR) of 3.3% from 2024 to 2031. North America, particularly the U.S., dominates this market, holding 36.7% of the market share in 2024[5].

Competitive Landscape

Savella competes in a market where patients often switch between approved drugs and off-label treatments due to dissatisfaction with current medications. The recent success of Tonix Pharmaceuticals' TNX-102 SL, which focuses on improving sleep quality and has shown favorable tolerability, poses a potential threat to Savella's market share. TNX-102 SL is expected to be submitted for FDA approval in the second half of 2024 and could capture a significant share of the market if approved[3].

Savings and Resources

For patients prescribed Savella, the SAVELLA Savings Program offers significant cost savings. Commercially insured patients may pay as little as $20 for a 30-day or 90-day prescription, making the drug more accessible[2].

Pregnancy Registry

The Savella Pregnancy Registry, sponsored by AbbVie, is an observational registry designed to monitor pregnancies exposed to Savella. This registry collects data on exposure to Savella, pregnancy outcomes, and pediatric outcomes to estimate the prevalence of major congenital anomalies and other adverse outcomes. This ongoing study is crucial for understanding the safety of Savella during pregnancy[4].

Future Projections

Given the competitive landscape and the ongoing development of new treatments, Savella's market position may face challenges. However, its established presence and the ongoing efforts to manage side effects effectively could help it maintain a significant market share.

Emerging Treatments

The emergence of new treatments like TNX-102 SL, which offers a novel approach by focusing on sleep quality and showing a favorable tolerability profile, may impact Savella's market share. The planned submission of TNX-102 SL for FDA approval in 2024 could introduce a new first-line therapy that might attract patients and healthcare providers looking for better tolerability and efficacy[3].

Key Takeaways

• Efficacy: Savella shows a small but significant improvement in pain inhibitory functions, fatigue, and mood in some patients.
• Tolerability: Managing side effects through gradual titration is crucial for patient adherence.
• Market: The fibromyalgia treatment market is growing, with Savella facing competition from emerging treatments.
• Cost Savings: The SAVELLA Savings Program helps make the drug more affordable for patients.
• Pregnancy Safety: The Savella Pregnancy Registry is ongoing to monitor the safety of the drug during pregnancy.

FAQs

Q: What is Savella used for?

A: Savella is used for the management of fibromyalgia, a chronic condition characterized by widespread muscle pain, fatigue, and other symptoms.

Q: How does Savella work?

A: Savella works by increasing the levels of norepinephrine (NE) and serotonin in the central nervous system, particularly at the nerve junctions.

Q: What are the common side effects of Savella?

A: Common side effects include nausea, headache, constipation, dizziness, insomnia, and others. Nausea is particularly notable.

Q: How can side effects of Savella be managed?

A: Side effects can be managed through a gradual titration period and altering the way the drug is taken.

Q: What is the current market outlook for Savella?

A: The fibromyalgia treatment market is growing, but Savella faces competition from emerging treatments like TNX-102 SL.

Sources

1. Fibromyalgia Fund: Savella for Fibromyalgia.
2. Savella.com: Savings and Resources | SAVELLA® (milnacipran HCI).
3. Stock Titan: Tonix Details Results Of Second Successful Phase 3 Trial And Plans.
4. CenterWatch: The Savella Pregnancy Registry | Clinical Research Trial Listing.
5. GlobeNewswire: Global Fibromyalgia Treatment Market Projected To Reach $3.86 Billion By 2031.