The FDA has recently accepted review for a new drug, Milnacipran, that is to be used to treat Fibromyalgia.Forest Laboratories, Inc. and Cypress Bioscience, Inc. submitted their New Drug Application (NDA) for milnacipran for the treatment of Fibromyalgia based on results from a composite responder analysis requiring that each patient experienced concurrent and clinically meaningful improvements in three validated measures: pain, patient global impression of change in disease status, and physical function.
The FDA advised that they are moving toward class labeling for drugs used to treat Fibromyalgia, with any distinctions among therapies reflected in specific product labels instead of differences in the approved indications.
Milnacipran is a unique dual-reuptake inhibitor that 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. Milnacipran is jointly being developed for fibromyalgia in the United States market by Forest and its licensor, Cypress Bioscience, Inc. Milnacipran was originally developed by and is sold outside of the U.S. by Pierre Fabre Medicament. Fibromyalgia is defined by widespread chronic pain, as well as a broad spectrum of related symptoms including fatigue, cognitive dysfunction, and reduced physical function.
I tried to email you to let you know I received the book, but the mail bounced back to me undeliverable. I hope everything is ok and that it was just your spam checker thinking it was spam 🙂
Thanks again 🙂
Sandy Robinson says
Thanks for letting me know you got it, Gloria! I’m not sure why the email didn’t go through. You are very welcome! 🙂
Sara Stewart says
Thank you for the heads-up!