Fibromyalgia drugs

Fibromyalgia drugs include prescription drugs currently approved or used off-label for Fibromyalgia (FM/FMS), and experimental drugs under investigation.

There are currently three FDA approved drugs for fibromyalgia:

• Cymbalta (duloxetine)
• Lyrica (pregabalin), and
• Savella (milnapracin)

FDA approved

Fibromyalgia Drugs - FDA Approved

Brand Name Drug Overview	Generic Drug Overview	Side Effects and Interactions	More on Side Effects and Interactions Not all side effects or possible drug interactions of brand name or generic name drugs are listed or linked in this chart.
Cymbalta	Duloxetine	Cymbalta Duloxetine	Cymbalta is facing lawsuits due to severe withdrawal symptoms. Eli Lilly has settled hundreds of personal injury lawsuits with patients experiencing severe withdrawal symptoms.
Lyrica	Pregabalin (2019)	Lyrica	Severe weight gain
Savella	Milnacipran	Savella Milnacapiran

Off-label

Off-label Drugs Used For Fibromyalgia

Brand Name Drug Overview	Generic Drug Overview	Off-label Use	Side Effects and Interactions	More on Side Effects and Interactions Not all side effects or possible drug interactions of brand name or generic name drugs are listed or linked in this chart. Brands and their generics can have different side effects and interactions. Review EACH brand name and EACH generic name medication's side effects and possible drug interactions with your doctor and pharmacist.
Florinef	Fludrocortisone	Orthostatic intolerance and POTS	Florinef Fludrocortisone	Weight gain Interacts with many other medications
Neurontin	Gabapentin	Pain, sleep	Neurontin Gabapentin	Weight gain
Remeron	Mirtazapine	Chronic insomnia	Remeron Mirtazapine	Severe weight gain Intense itching
ReVia, Vivitrol	Low-dose naltrexone (LDN)	Pain, positive mood, sleep quality, and fatigue	Revia Low dose naltrexone (LDN)	Must be stepped up slowly Opioids will be rendered ineffective
Seroquel (low dose)	Quetiapine (low dose)	Chronic insomnia	Seroquel Quetiapine (low dose)	Severe weight gain increased risk of Suicidal ideation or actions in children and young people under 25 Although prescribed for insomnia it is not recommended for this off-label use.
Ultram, ConZip, Qdolo	Tramadol	Pain	Ultram Tramadol	Tramadol induced seizure: A 3-year study Seizures
Zanaflex	Tizanadine	Chronic insomnia	Zanaflex Tizanidine

Sleep medications

Brands and their generics can have different side effects and interactions. Review EACH brand name and EACH generic name medication's side effects and possible drug interactions with your doctor and pharmacist.

Sleep dysfunction is a prominent symptom in FM. There are several types of sleep medications used for FM; antihistamines, benzodiazepines, nonbenzodiazepines, sedating antidepressants and sedating antipsychotics.

Drug trials

• ASP8062

• 2017, A Phase 2a, Randomized, Double-Blind Placebo-controlled, Parallel-group Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia

• Cannabinoid-based therapy

• 2017, Intec Pharma Launches Phase 1 Trial of Cannabinoid-based Therapy for Fibromyalgia, Lower Back Pain.

• IMC-1

• 2016, The Pridgen Revolution? Dr. Pridgen on Bringing His Antiviral Approach to Fibromyalgia To Market

Almost three years ago, Dr. Pridgen threatened to turn the world of fibromyalgia treatment on its head. Few had connected fibromyalgia with viruses or even immune problems when Pridgen announced that a) FM is caused herpes simplex virus reactivation and b) that it could be treated with antivirals.

• 2016, Novel Fibromyalgia Treatment Granted FDA Fast Track Designation

In the successful Phase II trial in fibromyalgia, IMC-1 was studied to confirm the hypothesis that chronic tissue-resident herpes simplex virus type 1 (HSV-1) may be one of the underlying causes of fibromyalgia and causally related to fibromyalgia symptoms or recurrence. IMC-1 is a novel fixed-dose oral combination antiviral medication designed to suppress this suspected virus and thus alleviate fibromyalgia symptoms.

• 2017, Through the “Valley of Death”: Dr. Pridgen, Fibromyalgia and the Looming Trials

First there were the anecdotal reports – FM patients were not just getting better but some, and not just a few, were getting well using something entirely new – an antiviral protocol, of all things, created not by a pain specialist or rheumatologist but by a surgeon.

• 2017, A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia

IMC-1 was efficacious and safe in treating symptoms of fibromyalgia, supporting the hypothesis that herpes virus infections may contribute to this syndrome. Improved retention rates, decreased adverse event rates, and evidence of efficacy on a broad spectrum of outcome measures are suggestive that IMC-1 may represent an effective, novel treatment for fibromyalgia.

Drug trials failed and drugs abandoned

• TNX-102

• 2016, The drug failed in its primary goal in providing pain relief and Tonix Pharmaceuticals will not be moving forward in developing a Ffbromyalgia drug.

• Phase III clinical trial of DS-5565 found ineffective

• 2017, The Big Hurt: Second Major Fibromyalgia Drug in a Year Fails

In the three 13-week, double-blind, global, phase 3 ALDAY clinical trials evaluating Mirogabalin for the treatment of pain associated with fibromyalgia, Mirogabalin did not meet the primary efficacy endpoint to demonstrate a statistically significant reduction in the weekly average of worst daily pain score from baseline to Week 13.

• BCG vaccine, the planned clinical trial was withdrawn in 2022

• 2017, Century-old vaccine gives new hope to fibromyalgia community
• 2018, FDA gives approval for clinical trial.

See also

• Fibromyalgia
• Drug-free pain management (category)
• Fibromyalgia disability process
• Fibromyalgia notable studies

Learn more

• Having Seizures or Blackouts? The Tramadol Connection
• How Lyrica Changes the Fibromyalgia Brain

• Why Your Fibro Meds Aren't Working

adverse reaction Any unintended or unwanted response to a treatment, whether in a clinical trial or licensed treatment. May be minor or serious.

adverse reaction Any unintended or unwanted response to a treatment, whether in a clinical trial or licensed treatment. May be minor or serious.

phase one A drug trial involving only a small group of humans, often healthy volunteers, to assess drug safety and side effects. Typically 20-80 participants, often using a comparison group.

phase three Last phase of clinical trials before a drug can be approved for public use. Whereas Phase one assesses basic safety, and Phase two assesses basic efficacy, Phase three uses many trial participants to fully assess both safety and efficacy, and overall benefit/risk.

double blinded trial A clinical trial is double blinded if neither the participants nor the researchers know which treatment group they are allocated to until after the results are interpreted. This reduces bias. (Learn more: www.nottingham.ac.uk)

phase three Last phase of clinical trials before a drug can be approved for public use. Whereas Phase one assesses basic safety, and Phase two assesses basic efficacy, Phase three uses many trial participants to fully assess both safety and efficacy, and overall benefit/risk.

See Agency for Healthcare Research and Quality.

Agency for Healthcare Research and Quality (AHRQ) - Agency for Healthcare Research and Quality is a United States government agency under the U.S. Department of Health and Human Services. Their mission is "to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable. A representative of the Agency for Healthcare Research and Quality sat on the (now disbanded) CFSAC committee as an Ex Officio Member.