GP Resources

Licensed Medications for the Treatment of Fibromyalgia


In the USA three medications have been licensed for the treatment of fibromyalgia, Cymbalta, Savella (Milnacipran) and Lyrica. However these have not all received the same status in the UK.

Cymbalta and Lyrica in the UK have licenses for neuropathic pain (and Cymbalta for depression). Savella is not licensed in the UK. Not receiving a UK license for these drugs does not mean that a British GP is unable to prescribe them, but it is "off-license" so if anything serious was to go wrong in terms of drug reactions etc. the GP would have to carefully justify his/her actions.


Cymbalta (trade name Duloxetine) is a serotonin-norepinephrine reuptake inhibitor. It has been approved by the FDA for the management of fibromyalgia and has been demonstrated to help reduce pain and improve function. Cymbalta is available only by prescription but is not a narcotic. Cymbalta comes in a capsule and can be taken once a day to help lessen pain associated with fibromyalgia.

Although the exact way that Cymbalta works in people is unknown, it is believed to be related to an increase in the activity of serotonin and norepinephrine, which are two naturally occurring substances in the brain and spinal cord.


Knowing When Cymbalta Is Working

Feeling the way you do now probably didn't happen overnight. Feeling better may take time, too. In diabetic nerve pain and fibromyalgia trials, some patients experienced less pain as early as one week. Results may vary from person to person. Cymbalta may take some time to take effect, so it is important to track your improvement over time. That way your doctor can assess your progress and determine if you should continue or stop taking Cymbalta.


In clinical studies, the most common side effects identified in patients taking Cymbalta included:

·         Nausea

·         Dry mouth

·         Sleepiness

·         Fatigue

·         Constipation

·         Dizziness

·         Decreased appetite

·         Increased sweating



Pregabalin (trade name Lyrica), an anticonvulsant drug, was originally used for neuropathic pain and as an adjunct therapy for partial seizures. It was designed as a more potent successor to Gabapentin. Recent studies have shown that Pregabalin is effective at treating chronic pain in disorders such as fibromyalgia.


Lyrica (Pregabalin) capsules are indicated for management of fibromyalgia and not for improvement in specific symptoms such as problems sleeping and fatigue. It is unknown exactly how LYRICA works in the body. Animal studies suggest that Lyrica reduces “extra” electrical signals sent out by overactive nerves.


The most common side effects are:

·         Dizziness

·         Blurry vision

·         Weight gain

·         Sleepiness

·         Trouble concentrating

·         Swelling of hands and feet

·         Dry mouth

·         Feeling "high"


In 2009 Milnacipran (trade name Savella) a new SNRI (serotonin and norepinephrine reuptake inhibitor) became the third medication to be approved by the US. In clinical studies, Savella helped relieve the symptoms of fibromyalgia. Some patients who experienced overall improvement with Savella also experienced pain reductions one week after they reached a stable dose.


In clinical studies that compared Savella to placebo, patients who took Savella experienced the following benefits:Pain reduction; Overall fibromyalgia improvement; and Improved physical function. To get the best results, be sure to take Savella as instructed by your healthcare provider.


Possible side effects include:

·         Nausea

·         Headache

·         Constipation

·         Dizziness

·         Insomnia

·         Hot flush

·         Excessive sweating

·         Vomiting

·         Palpitations

·         Increased heart rate

·         Dry mouth

·         Hypertension


Future Medication for Fibromyalgia – Xyrem

In America Sodium Oxybate (trade name Xyrem) is gaining a lot of publicity for the affect it is having with helping FM sufferers. This looks a promising new drug but it is expensive and it contains a substance with a history of abuse, so any restrictions will be very strict. Clinical trials of JZP-6 (the active ingredient in Xyrem) showed that it significantly improved sleep quality and reduced pain in fibromyalgia patients.

In March 2011 European regulators have turned down Xyrem as a treatment for fibromyalgia. Currently, the drug is only approved for the treatment of narcolepsy. It has been prescribed for 35,000 people since it was introduced in 2002.


No medication has been approved in Europe to date for the treatment of fibromyalgia.

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