New Drug Application for Fibromyalgia

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New FDA Drug Application for FM Treatment

Friday, March 14, 2008

FMOnline vol. 8, no. 3

Late last year, Forest Laboratories, Inc., and Cypress

Bioscience, Inc., submitted a New Drug Applciation

(NDA) to the US Food and Drug Administration for

milnacipran, a dual-reuptake inhibitor being developed

for the treatment of fibromyalgia. The NDA for

milnacipran is based on a composite responder analysis

that requires each patient to experience concurrent

and clinically meaningful improvements in three

validated measures: pain, patient global impression of

change in disease status, and physical function. This

approach is considered a more stringent assessment of

therapeutic effect than the evaluation of individual

symptoms.

The submission includes efficacy data from two pivotal

Phase III trials involving 2,084 patients (1,460

milnacipran, 624 placebo), which showed that

milnacipran demonstrated improvement compared to

placebo in treating FM. Moreover, safety data

collected from 2,209 patients (1,557 milnacipran, 652

placebo) during the development program demonstrated

that milnacipran was generally well tolerated, with

the majority of adverse events reported as mild to

moderate in nature.

Milnacipran preferentially blocks the reuptake of

norepinephrine with higher potency than serotonin, two

neurotransmitters known to play an essential role in

regulating pain and mood. It has been approved for a

non-pain condition in over 50 countries, with

real-world commercial experience outside the U.S. for

10 years.

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