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Monday, January 19, 2009

FDA approves Savella(TM) (milnacipran HCl) for Fibromyalgia


From Medical News Today, FDA Approves Fibromyalgia Drug - Savella(TM) (milnacipran HCl), A Selective Serotonin and Norepinephrine Dual Reuptake Inhibitor

"Although the exact mechanism by which Savella improves the symptoms of fibromyalgia is unknown, some researchers believe that abnormalities in certain brain neurotransmitters may be central to fibromyalgia. Savella blocks the reuptake of both norepinephrine and serotonin, with greater selectivity for the inhibition of norepinephrine reuptake in vitro (does anyone know what the term in vitro means in this context? Emphasis added by me.) . This may be the mechanism by which Savella acts to improve the symptoms of fibromyalgia."

and

"The efficacy of Savella was established in two US pivotal Phase III clinical trials involving 2,084 treated patients (1,460 Savella; 624 placebo), which showed that Savella demonstrated clinically significant improvements compared to placebo in treating fibromyalgia. The first study was 6 months in duration and the second study was 3 months in duration.

"In both studies, a greater proportion of patients in the Savella treatment arms (100 mg/day and 200 mg/day) as compared with placebo treatment, at 3 months, experienced at least a 30% reduction in pain from baseline and also rated themselves as "very much improved" or "much improved" based on the patient global assessment. In addition, a greater proportion of patients treated with Savella as compared with placebo treatment met the criteria for a treatment response as measured by concurrent improvements in pain, physical function, and patient global assessment. In both studies, some patients who rated themselves as globally "much" or "very much" improved experienced a decrease in pain as early as week 1 of treatment with a stable dose of Savella that persisted throughout these studies."

It would be nice to see some real numbers here. Like exactly what percentage of patients experienced exactly what percentage of improvement in exactly which areas? Guess it's a secret for now.


From Forbes: Cypress shares jump on FDA approval for Savella
"It is part of a class of drug called serotonin-norepinephrine reuptake inhibitors, which include antidepressants Effexor, Pristiq and Cymbalta."

And last but not least, this comment from an article in a San Diego paper, Brainstorming brings about Fibromyalgia drug, kind of says it all for me:
"Also of note, Cymbalta and Effexor (and Pristiq) are the same type of drug as Milnacipran, and they are already available in the US. Not sure why this company decided it needed to bring yet another combined SSRI/SNRI to market. Oh wait... "revenue from Savella will likely reach $781 million annually by 2012." Wow, those altruistic guys from Cypruss really tug at the heart strings!"

Friday, January 2, 2009

My REAL Holiday Newsletter

Last week Sick Momma wrote about those annual holiday letters in Cue the Violins. She likes to receive them just like I do. She worries because she is starting to get dropped of some peoples' holiday card lists because she hasn't had the energy to send any cards out herself for the last couple of years.

She writes:
...it's like one more connection with the "healthy" world at large is getting thinner and thinner.

Everything just seems harder than it should be, and more complicated than it needs to be.

Sigh. I know what she means.
For the last ten years I've been dealing with gradually worsening and multiplying chronic illnesses, as well as a divorce. (Yeah, I dragged the divorce out for ten years so I could at least get SOME of the money I put into the house out of it.) It's been at least that long since I've been able to send cards out, and since I had to move to another state and then became unable to work, I've been wanting to send a holiday letter to everyone I'd like to keep in touch with to let them know why I've been out of touch. I've been trying to find the right balance between honesty and optimism since 2003. Seriously. Look at this picture: I've scratched a new year in for four years from 2003 to this year, and each year I add some to the letter and take some away, but still it doesn't seem ready to send.

My description of my life reminds me of a parody of a holiday letter. MSNBC writes in Readers share most notorious Christmas letters:
...anti-holiday joy letters — those copied correspondences recounting personal details of messy divorces, memorializing deceased pets and reviewing all physical maladies endured throughout the year.

One daughter demanded her mother recall her letter after she realized it disclosed the daughter's broken engagement and unhappy job situation.

Ugh.

Fortunately for me there are now a plethora of tips on the internet about writing holiday letters. I just found them this year, and some of them are quite good:
If, sadly, you are house-bound, the children have moved away and you haven't read any great books, you don't have to write about this year's aches and pains. Write about Christmas when you were a child, or how you met your spouse, or your funniest date in high school. "Not much happened this year. Christmas always reminds me of the time during the depression when we made ornaments out of tin foil. . .". Your grandchildren will have a glimpse of real history, and your friends will nod in pleasant agreement, remembering their own experiences. Don't try to cram 80 years into one page. Pick an incident or season and write about it in enough detail people will know what it was like. My Biography Questions page has some specific questions/topics, if you can't think of anything.
From Christmas Newsletters - Suggestions and Examples
For those of us who have a hard time doing the actual physical work necessary to getting a Christmas newsletter out, we can go digital! This option will probably sound especially lucrative to the bloggers among us. See The Art of Christmas Letter Writing, Creating Digital Christmas Letters.

While I didn't get all this research done in time to get my letter out this year (again!), to say nothing of getting my names and addresses ready to do a mail merge thing, I did get a lot done on it ,and I really think I'm going to get my letter out next year. And as Sick Momma says, I'm still having a lot of testing done, I'm making a lot of behavioral as well as treatment changes according to what I've found out already with the help of the Fibro and Fatigue Center, and I'm sincerely hopeful that next year's version of my Christmas letter will be both honest and optimistic.

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