Swiss biotech firm Serono SA, which earlier Thursday agreed to sell a majority stake in the company to German drugmaker Merck KGaA for $13.31 billion, said its oral cladribine treatment for multiple sclerosis has received 'fast-track' status from the U.S. Food and Drug Administration. This designation covers patients with relapsing forms of multiple sclerosis.
Serono's oral form of cladribine is currently being evaluated in a multi-center, multi-national Phase III study called CLARITY. It is a two-year, double-blind, placebo-controlled study involving more than 1,200 patients. Patient enrollment is planned to be completed by the end of 2006.
This kind of news used to get me all excited, but not so much anymore. I'm not sure, but I think I'm probably more secondary-progressive than relapsing-remitting. (Is this something I need to know, what form of MS I've got?) It's been years since I had a recognizeable exacerbation. These days, I'm more interested in finding pain relief than in reducing the number of enhancing lesions or whatever clinical measure is used to tout the latest MS drug.
Not that I'm complaining about the way things have turned out for me: I'm about 14 years out from my initial MS symptoms, 13 years past diagnosis, and I'm still mostly upright. On Wednesday, my neurologist told me that at this stage in the game, most MS patients aren't doing quite as well. Neurologically, my grades are pretty good, I guess, except the pain.
Last night, I started Cymbalta again. Third time's the charm? We'll see. The urologist says double up on the Flomax to counteract Cymbalta's retention effect. For the last couple days, I've left the office at 4-ish, because the burning and squirming left me completely unable to get anything done. Here's hoping Cymbalta will improve things, because my work load is steadily ramping up.
Link to CBS story.