A pill. Wouldn’t that be nice? We’re not asking for much. Why do all of those other diseases get pills and we get injections? I know – Diabetes gets shots too. And I’m sure there are others. My apologies to those diseases that suck like MS because you have to give yourself a shot.
Sure, there have been pills that we take for symptom relief or control. But the disease-modifiers – the ones that we hope are holding the MonSter at bay – they’ve been rather elusive. There are 2 oral disease-modifying drugs currently approved for Multiple Sclerosis. The first, Gilenya or Fingolimod, has been on the U.S. market since 2010, with a prescribing revision coming in April of 2012 due to heart issues. It has some good numbers: 54% reduction in relapses and 30% reduction in risk of disability progression. That sounds pretty good. Well, there were those deaths. But – apparently the screening was tightened up to exclude those with heart problems and the FDA was good with that. First dose monitoring in your doctor’s office is required for 6 hours with EKG’s before and after the 6-hour window. A little worrisome, but compared to shooting up, it’s not sounding too bad.
Then along came Aubagio, FDA approved in September 2012. It reduces relapses by about 33%. Maybe not as impressive as Gilenya’s 54% reduction, but people weren’t grabbing their chest and falling over either. This one requires a close watch on liver enzymes. There’s a boxed warning, in fact, about potential liver damage and another one about causing significant birth defects. And, it stays in your system for 8 months. Not a good choice if your of child-bearing age. What was the average age of diagnosis? Oh yeah – 20-50. By the way, Aubagio also lists peripheral neuropathy as a potential side effect. Hmmm – already got that. Thank you.
So – until now – them’s been our choices. My doctor has been touting a new drug that’s been in the pipeline for several years. You may have heard of it. It’s call BG-12 – dimethyl fumarate. The New England Journal of Medicine reported in it’s September 20, 2012 issue that BG-12 showed, in Phase 3 trials, a 53% reduction in relapses and a 38% reduction in progression. In it’s conclusion, the Journal noted BG-12 “significantly reduced the proportion of patients who had a relapse, the annualized relapse rate, the rate of disability progression, and the number of lesions on MRI.” Sounds pretty good, huh? Are there side affects you ask? Well, of course there are. These include “flushing and gastrointestinal events” (assumedly those would require “flushing” as well). Originally BG-12 was slated for FDA approval in December, 2012. For whatever reason – and I’m assured it wasn’t something catastrophic like a missed brain aneurysm side affect – it was pushed back several months. However, it appears to be on-track for approval in March of 2013. So – now we’ll have some choices that don’t involve needles.
I recently chose to discontinue my affair with the needle – as documented in my post Needles No More. I would certainly entertain an oral remedy. For now, at least, I’m done. I’m not interested in any more needles. A pill? Well, yeah, maybe. Then there’s LDN. But that’s another blog post altogether – and a podcast. So – what are your thoughts on going “on the pill”? Have you made the jump? Will you? Are you okay with the shots? Maybe you feel like “if it ain’t broke don’t fix it.” Share with the community. Please, leave a comment in the comment section below this post. Thanks.
It seems to help the stress, just to say F-U-M-S!!
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