Why isn't Mucosolvan (Ambroxol) sold in US pharmacies?

November 14, 2014 1:39 PM

Ambroxol is an over-the-counter medicine used to thin mucus secretions, similar to the commonly sold guaifenesin. I've been able to buy it in Europe (usually under the brand name Mucosolvan) for a long time now. They even make a kids' formula! But why isn't it sold in the US?

Looking around, it seems to be sold all over the world. The molecular formula doesn't seem to be under a patent because there are a myriad of companies making and selling it.

Everything I've read about it regards it as safe. One paper seems to think it can even help with sore throats and another says it can possibly shorten the duration of a rhinovirus if taken early.

The only negative thing I've found so far is a citation that ambroxol can mess up an abused-drug screening test for LSD.

I have my own stash that I bring back from Europe, but as I run out again this cold & flu season and my kids protest the other stuff, I'm just curious why this drug has never passed the FDA here. Or has it never been submitted? Anyone know?

posted by JoeZydeco to Health & Fitness (6 answers total)

Best answer: It was patented over 30 years ago and the patent is expired. Given its age, it's unlikely that safety studies done at the time would meet the FDA's current requirements. It may not be enough of a profit center for any single drug company to bother with the clinical trials that would be needed to pass the FDA.
posted by The Elusive Architeuthis at 1:46 PM on November 14, 2014 [3 favorites]

Best answer: Ultimately, the answer is likely "nobody thinks they could make money off it." Which is a pity, because reading up it sounds like the stuff is a million times better than Mucinex (which is just time-release guaifenisen, nothing special) and I want to get my hands on some.

It is really really expensive to get a drug through FDA validation, certification, etc etc.
posted by Lyn Never at 1:53 PM on November 14, 2014 [1 favorite]

Response by poster: Thanks. It never occurred to me that the molecule would be too old to introduce to North America. Shame, really. But when it costs 200MM+ to pass the FDA, only to have it classified as generic, it's understandable.

It's really different than mucinex/guaifensein, but I can't explain why. It's milder, works slightly differently, and the kids formula doesn't taste that bad. I've never had a guaifenesin formula that didn't taste 100% awful, you can't mask it I guess.

Anyway, thanks again Elusive and Lyn.
posted by JoeZydeco at 5:40 AM on November 15, 2014

I think there are FDA clinical trials to use ambroxol for Parkinson's and Gaucher's disease. So that might introduce it into the US, albeit by prescription, I guess.
posted by odin53 at 7:03 AM on November 15, 2014

Crazy thought but have you tried ordering from any of the Canadian online pharmacies?
posted by bitter-girl.com at 8:21 AM on November 15, 2014

Response by poster: It's my understanding it's not sold in Canada or Mexico, either.
posted by JoeZydeco at 12:16 PM on November 15, 2014