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."
"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!"