Drugs in Development for Fibromyalgia Syndrome

Because the causes of fibromyalgia syndrome (see ‘What Causes Fibromyalgia Syndrome?’) are still under discussion, it is hard for companies to develop drugs specifically for the disorder. However, a number of companies are either developing new treatments, or looking to see if existing drugs might be useful in treating fibromyalgia syndrome.

Savella (milnacipran)

Pierre Fabre originally developed milnacipran as an antidepressant and launched it in around 50 countries. The company licensed milnacipran (trade name Savelle) to Forest Laboratories and Cypress Bioscience in the USA, and the three companies have been developing the drug for fibromyalgia syndrome.

In a phase III (large-scale) trial, Savella significantly improved pain in fibromyalgia syndrome, and was well tolerated, with side effects of nausea, palpitations, depression and headache causing less than 5% of the people in the trial to stop taking the drug.

Cypress Bioscience and Forest Laboratories gained approval to begin marketing milnacipran in the USA in January 2009 for fibromyalgia syndrome, and it is likely to be available in US pharmacies in March 2009. Pierre Fabre has submitted the drug for marketing approval for fibromyalgia syndrome in Europe.

Xyrem (sodium oxybate, JZP-6)

Jazz Pharmaceuticals and UCB are developing Xyrem as a potential treatment for fibromyalgia syndrome.

In a large study, 39-46% of people receiving different doses of the drug showed a significant reduction in pain.

The two companies hope to apply for approval to market the drug in late 2009, but it may not be available on the market for a while after that.

Effirma (flupirtine)

Adeona Pharmaceuticals is developing flupirtine for the treatment of fibromyalgia syndrome. Originally developed and marketed for lower back pain, it was occasionally used ‘off-label’ (without marketing approval) in fibromyalgia syndrome.

In a small trial, flupirtine was well tolerated in people with fibromyalgia syndrome, and the company is planning a larger trial.

Droxidopa

Chelsea Therapeutics International is developing droxidopa, a drug originally developed for low blood pressure, in the treatment of fibromyalgia syndrome. This may also have potential in combination with carbidopa, a drug used in Parkinson’s disease.

The company is studying droxidopa, alone or in combination with carbidopa, in a phase II trial involving 120 people, and expects to have results from the trial in 2010.

Vimpat (lacosamide)

UCB is looking at its anti-seizure (anticonvulsant) medication Vimpat as a possible treatment for fibromyalgia syndrome. A trial of Vimpat has shown some activity in fibromyalgia syndrome. The drug is approved in the USA and Europe for use in partial-onset seizures, and is in phase II (mid-size) trials for fibromyalgia syndrome.

Edronax (reboxetine)

Pfizer is studying its antidepressant, Edronax, as a potential treatment for fibromyalgia syndrome. A large trial phase III trial is expected to complete in April 2009, with the company predicting a submission for approval somewhere around 2010 to 2012.

Nabilone

Nabilone is based on the active ingredient in cannabis, and reduced pain and anxiety on fibromyalgia syndrome in a clinical trial. It may not be in active development for fibromyalgia syndrome, but may be useful in the future.