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Home Industry News Forest and Cypress submit NDA for milnacipran

Forest and Cypress submit NDA for milnacipran

2nd January 2008

Forest Laboratories and Cypress Bioscience have submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its dual-reuptake inhibitor milnacipran in the treatment of fibromyalgia syndrome (FMS).

The application is supported by a composite responder analysis which requires patients to experience concurrent and clinically meaningful improvements in pain, patient global impression of change in disease status and physical function.

Such a method has been highlighted by the companies as a more thorough assessment of therapeutic effect than the evaluation of individual symptoms.

The submission is based on two phase III trials which involved over 2000 patients.

Study data showed that milnacipran demonstrated improvement compared to placebo in treating FMS.

Safety results from the development programme also found that milnacipran was well tolerated with most adverse events found to be moderate or mild.

Milnacipran has previously been approved for a non-pain condition in over 50 countries,

FMS is a chronic and debilitating condition characterised by widespread pain and stiffness throughout the body which can be accompanied by fatigue, insomnia and mood symptoms.

Last month, Forest Laboratories and Mylan reported that the FDA approved its beta blocker Bystolic in the treatment of hypertension.

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