NEW drug for fibro and CFS looks like its on its way!

Discussion in 'Fibromyalgia Main Forum' started by AC77, May 31, 2003.

  1. AC77

    AC77 New Member


    SAN DIEGO--(BUSINESS WIRE)--May 29, 2003--Cypress Bioscience, Inc. (Nasdaq:CYPB - News) announced today that clinical results with its lead product, milnacipran, appear to demonstrate distinct mechanisms for the agent's effects on pain and mood in patients with Fibromyalgia Syndrome (FMS) as presented in a poster presentation by R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Cypress Bioscience, Inc. The poster, entitled "Development of Milnacipran, A Dual Reuptake Inhibitor for the Treatment of Chronic Pain Associated with Fibromyalgia," is being presented today at the annual New Clinical Drug Evaluation Unit (NCDEU) meeting, sponsored by the National Institutes of Mental Health (NIMH) in Boca Raton, Florida.

    In the study, twice-daily dosing of milnacipran was associated with statistically significant improvements in multiple measures of clinical pain. Other symptoms, including fatigue, mood and patient global improvement reports, were significantly improved in both the once-daily and twice-daily dosing groups, and achieved statistical significance on many of these secondary measures. These findings suggest different therapeutic mechanisms may be operative within different symptom domains of FMS.

    Milnacipran is a first-in-class Norepinephrine Serotonin Reuptake Inhibitor (NSRI) in late-stage clinical development for the treatment of FMS. Pharmacologically, this agent is differentiated from the Selective Serotonin Reuptake Inhibitors (SSRIs), as well as from the Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), by its preferential blockade of norepinephrine (NE) reuptake over serotonin (5-HT) reuptake. Milnacipran's NE/5-HT profile most closely mimics that of the tricyclic antidepressants (TCAs), a class of compounds with demonstrated effectiveness in FMS. One of milnacipran's potential benefits is that it lacks the other drug characteristics that underlie the TCAs' side effects and can limit their tolerability and usage.

    The Phase II clinical trial results presented at NCDEU demonstrate the safety and efficacy of milnacipran in treating patients with FMS. A total of 125 patients were enrolled in the trial and were randomized to receive either placebo or milnacipran. Milnacipran was dosed either once or twice a day for four weeks of dose escalation, followed by eight weeks of constant dose. The study evaluated the efficacy and safety of milnacipran for the treatment of pain and associated symptoms such as fatigue, depressed mood, quality of life and ability to sleep.

    A Phase III clinical program is currently being planned and is expected to commence before the end of the year.


  2. Shazzy

    Shazzy New Member

    Hi,

    That is fantastic news, where you hear about that information.
    I wish i could take it today.

    Shazzy
  3. lucky

    lucky New Member

    can't wait until it gets on the market.
    Sincerely, Lucky
  4. judywhit

    judywhit New Member

    how many pounds do you think it will put on a person????
    How about taking away our sex-drive??????
    This one is a given....expensive!
    thanks for the post Ac77... just be causious.
    Judy
  5. Sissy123

    Sissy123 New Member

    Arn't those like elavil? They make my Restless leg syndrome worse. I really dont need that. If it is like those drugs I wont take it because it will keep me up at night with my legs moving and still being tired. Will be different than that? I hope so. Sis
  6. AC77

    AC77 New Member

    I dont know anything. I cut and pasted this article from an online trade-journal. It is in phase III of FDA trials, so it may or may not pass--most likely will, but will take some time. It's not a tricyclic but seems to have some of it's abilities....I am venturing a guess it has some putative opiod qualities, like Ultram. I would be able to tell more by see a sample of it's molecular structure, to see what it resembles.

    This is just another tool in our aresenal that will work for some but not everyone. And I doubt will be as promising as it is being made to appear. who knows? Time will tell.
    I hope it works!
  7. Lendi

    Lendi New Member

    I've tried to do some research on it and it certainly sounds promising. Please let us know when it hits the market. I'll be one of the first to talk to my Dr. about it! I'm hoping it might be able to take the place of both my celexa and resteril.