Forest Laboratories starts fibromyalgia trial

Forest Laboratories and Cypress Bioscience are to commence late Phase III trials for the fibromyalgia treatment Milnacipran after previous trials showed a limited effectiveness.

The new trial will start in the first three months of the year with some modifications to the ongoing second Phase III study, including the increase the number of patients involved from 800 to 1,200.

Forest and Cypress decided to continue with the study as the first Phase III study was supportive of milnacipran’s effect in fibromyalgia patients.

The companies now expect first results from the study in the middle of 2007.

Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. Currently there are no treatments specifically approved for the condition.

Milnacipran is from a new class of agents known as norepinephrine serotonin reuptake inhibitors, which take effect by preferentially inhibiting the reuptake of norepinephrine over serotonin, two neurotransmitters that are known to have a key role in regulating pain.

© Adfero Ltd