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Dr. Bob is Robert Hsiung, MD,
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Posted by Phillipa on January 18, 2009, at 13:11:55
I think this is good news for fibromyalgia sufferers as if the FDA approved a med for it that now believe it is real. Let me know what you think. I understand it to be a combine SNRI and SSRI. Guess kind of like cymbalta. Love Phillipa
FDA Approves Milnacipran for Fibromyalgia
January 15, 2009 Forest Laboratories and Cypress Bioscience announced January 14 that the Food and Drug Administration (FDA) has approved milnacipran (Savella), a dual serotonin- and norepinephrine-reuptake inhibitor (SNRI), for the management of fibromyalgia.Efficacy of the drug was established in 2 pivotal US phase 3 trials, the companies note in a press statement. Treatment with 100-mg/day and 200-mg/day doses demonstrated "statistically significant and clinically meaningful" concurrent improvements in pain, patient global assessment, and physical function, the statement adds.
The companies expect the drug to be available in pharmacies by March 2009.
Fibromyalgia, characterized by widespread pain and decreased physical function, affects as many as 6 million people in the United States, according to estimates from the American College of Rheumatology, the statement notes.
Although the exact mechanism of the benefit of milnacipran in this setting is not known, "some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia," the release states. Milnacipran blocks reuptake of serotonin and norepinephrine, with greater selectivity for norepinephrine in vitro. "This may be the mechanism by which [milnacipran] acts to improve the symptoms of fibromyalgia."
Phase 3 Trials
Data to support this indication were taken from 2 phase 3 trials that used a "composite responder analysis," the statement states. "This end point required individual patients to demonstrate concurrent improvement to multiple validated measures, including pain (visual analog scale), patient global assessment (patient global impression of change), and physical function (Short Form-36 Physical Component Summary)," the companies note.
The phase 3 trials, 6 months and 3 months in duration respectively, included 2084 patients, 1460 treated with milnacipran and 624 with placebo. In both studies, a greater proportion of patients treated with 100 or 200 mg/day of milnacipran had at least a 30% reduction in pain from baseline and rated themselves as "very much improved" or "much improved" on the patient global assessment. More treated patients also met criteria for treatment response by concurrent improvements in pain, physical function, and patient global assessment.
The treatment was safe and generally well tolerated. The most frequently occurring adverse reaction was nausea; other common reactions included constipation, hot flush, hyperhidrosis, vomiting, palpitations, increased heart rate, dry mouth, and hypertension. The majority of these reactions were mild to moderate in nature, the statement adds.
Cautions
As an SNRI, milnacipran is similar to other drugs used for the treatment of depression and other psychiatric disorders, the statement points out. Antidepressants cause increased thoughts of suicidality in children, adolescents, and young adults compared with placebo. Although it is not approved for major depressive disorder or in pediatric patients, "patients of all ages who are started on [milnacipran] should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior," the press release states. "Families and caregivers should be advised of the need for close observation and communication with the prescriber."
A variety of other contraindications are noted in the release. The drug should not be taken concomitantly with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI. Development of potentially life-threatening serotonin syndrome can occur with drugs that, like milnacipran, inhibit serotonin reuptake, particularly with concomitant use of serotonergic drugs such as triptans or tramadol or with drugs that impair metabolism of serotonin such as MAOIs. Concomitant use with serotonin precursors is also not recommended.
Blood pressure and heart rate should be monitored prior to initiating treatment and periodically during treatment, as SNRIs, including milnacipran, have been shown to increase blood pressure and heart rate. Preexisting hypertension, tachyarrhythmias, and other cardiac diseases should be treated before use of the drug, the release notes, and it should be used with caution in patients with significant hypertension or cardiac disease. For those who experience a sustained increase in blood pressure or heart rate on treatment, either dose reduction or discontinuation should be considered, the release states. Gradual reductions in dose are recommended, as withdrawal symptoms have been observed following discontinuation of milnacipran.
Mild elevations in liver enzymes have also been observed with treatment and, rarely, fulminant hepatitis, the statement adds. It also increases bleeding risk, and patients should be cautioned about concomitant use of milnacipran and nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, warfarin, or other drugs that affect coagulation.
Milnacipran should be prescribed "with caution" in patients with a history of seizure disorder, mania, or controlled narrow-angle glaucoma and should "ordinarily not be prescribed" in patients with substantial alcohol use or evidence of chronic liver disease, the statement adds.
Posted by bleauberry on January 18, 2009, at 15:03:40
In reply to Good News For Fibromyalgia FDA Approves Milnacipra, posted by Phillipa on January 18, 2009, at 13:11:55
Did I read that correctly? Milnacipran in the USA? Well, I'll be. That is so cool.
And given that FDA recently gave the go-ahead thing about off-label uses of meds, I hope it doesn't take much time for pdocs, GPs, and public to discover that in all the rest of the world Milnacipran is not primarily for Fibro, it is primarily an antidepressant. And a real good. It is for example huge in Japan.
It is an NSRI, that is, norepeniphrine serotonin reuptake inhibitor. Or SNRI, either way. Its ratio is basically equal, with 3 parts NE to 1 part 5ht. The other meds in its class, Cymbalta and Effexor, are predominantly just 5ht with a scant bit of NE. (Cymbalta 9:1 5ht:NE; Effexor 30:1 5ht:NE).
Anyway, I've tried em all. Milnacipran definitely has a total different feel to it. Even though it is strong on NE, it does not at all feel like Reboxetine. Milnacipran is just different. It often begins working fast, like within a few days or one week. In theory researchers have said that might have something to do with its rapid desensitization of 5ht1a receptors. I think most people will like it. In studies where depression patients were carried to at least 12 weeks, response rates were in the mid 80's and high remission rates too.
Posted by Glydin 3.9 on January 18, 2009, at 19:06:35
In reply to Good News For Fibromyalgia FDA Approves Milnacipra, posted by Phillipa on January 18, 2009, at 13:11:55
> I think this is good news for fibromyalgia sufferers as if the FDA approved a med for it that now believe it is real. >
~~~ Just A med ? Evidently it was believed to be real in 2007 if FDA med approval is a clue to if something is real...
Posted by Phillipa on January 18, 2009, at 21:28:05
In reply to Re: Good News For Fibromyalgia FDA Approves Milnacipra, posted by bleauberry on January 18, 2009, at 15:03:40
I agree straight from licensed nursing site on WebMD. So a new one which is great. Love Phillipa
Posted by Phillipa on January 19, 2009, at 12:35:00
In reply to Re: Good News For Fibromyalgia FDA Approves Milnacipra, posted by bleauberry on January 18, 2009, at 15:03:40
Did I read it and you correctly it works in a week or so? That's wonderful. Phillipa
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