Archive for August, 2010

Possible New Fibromyalgia Drug & Odds of FDA Approval

August 7, 2010

Original Published by Adrienne Dellwo on August 6, 2010

In just 2 weeks, an FDA panel will review the New Drug Application (NDA) for the next possible fibromyalgia drug, sodium oxybate, and make a recommendation to the FDA either for or against approval.

This drug has a couple of things going for it. it’s fared well in clinical trials, lowering pain and fatigue as much as 30% in a significant number of people. It’s already on the U.S. market as Xyrem (for narcolepsy), so it has an established safety record that’s pretty decent. Still, it faces some big obstacles to approval — it carries a risk of addiction; and in the wrong hands, it’s sometimes used to get high or as a “date-rape” drug.

This whole process is a little confusing: If it’s so dangerous, why is it on the market? And if it’s already on the market, why did Jazz Pharmaceuticals have to submit an NDA, instead of just applying for an additional use? I’ve had a hard time getting answers to these questions, so I owe thanks to a couple of stock-market bloggers — Rockford Coscia at Seeking Alpha and Adam Feuerstein at TheStreet — for putting this information out.

Xyrem, which is approved for narcolepsy, is a powerful sedative and a Schedule III controlled substance. It’s a liquid, and the instructions say to take it in bed and lay down immediately — it works that fast. That makes it pretty attractive to those who want to misuse it. To keep it out of criminal hands, the FDA and Jazz have worked to strictly regulate Xyrem. You have to meet strict criteria to get it; your doctor can only prescribe a limited amount; and it’s couriered right to you. So far, according to a Jazz-funded study, that system appears to have worked pretty well.

However, a relatively small number of people have narcolepsy — 1/2000, compared to 1/50 with fibromyalgia. Xyrem has what’s called “orphan drug status,” which means it can only be distributed to a small number of people.

Approval for wider use is a whole different ballgame. The FDA advisory panel, or the FDA itself, may balk at the sheer number of people who could be prescribed sodium oxybate for fibromyalgia. Would Jazz be able to control access tightly enough? It’s a question that’ll have to be answered before this drug is approved.

The addiction issue is a big one — we already have problems getting access to narcotics because of the risk (even though it’s been found to be minuscule in legitimate pain patients.) When you combine the risk of addiction and illegal use, it gives the FDA plenty to think about, beyond whether the drug works or not.

The panel meets August 20 and FDA’s decision is due in October, so we don’t have too long to wait.

Kelli’s Note: The FDA only approves medication for the United States, however, if there is approval there, it will eventually, hopefully trickle down to the rest of us fibromites that aren’t American.

Original Source:’s Fibromyalgia & CFS Blog