FDA Approves Tramadol Extended-Release Formulation | Arthritis Information

Labopharm announced that the Food and Drug Administration (FDA) has approved an extended-release once-daily formulation of tramadol (Ryzolt) for the management of moderate to moderately severe chronic pain.

The new formulation of tramadol uses the company's proprietary controlled-release technology (Contramid) for oral administration of existing solid-dosage medications and is the first approval in the United States obtained by Labopharm for 1 of these compounds.

A statement from the company announcing the approval on December 31 notes that the formulation is "composed of a dual-matrix delivery system with both immediate-release and extended-release characteristics." Labopharm and marketing partner in the United States, Purdue Pharma, anticipate launching the product in 100-mg, 200-mg, and 300-mg dosage strengths in the second quarter of 2009, the statement adds.

"In a society where people with pain are increasingly demanding simplified dosing regimens, this once-daily formulation of tramadol should be embraced by physicians and patients alike," Nicholas J. Messina III, MD, from Vista Medical Research, in Mesa, Arizona, principal investigator of the US clinical studies of Ryzolt, said in the company release.

To date, the company's once-daily tramadol product has been launched in 14 countries, including Canada and Europe, and is either approved or under regulatory review in 29 countries.

The company develops novel compounds by combining existing small-molecule drugs with its proprietary controlled-release technologies, the statement adds. A second product, a controlled-release formulation of trazodone for the treatment of major depressive disorder, is currently under review by the FDA, the release notes.

http://www.medscape.com/viewarticle/586329

I was reading about this earlier....its only going to be available here in the UK towards the middle of the year....I take 2 tramadol( zamadol) in the morning and 2 at night so one a day would be goodIn my opinion, extended release meds work much better to treat chronic pain.Lynn492009-01-08 18:32:13

I'd be willing to try it! The side effects from Tramadol are much less than the ones I have with Vicodin. Although, the tram doesn't seem to work near as well in taking my pain away.

I wonder if they could make our RA meds this way, too? That's probably a dumb question on my part. Now that I think of it, aren't the IV RA meds sorta "extended release" since the infusions are set so far apart?

How does the higher incident of seizures fit into this extended relief? [QUOTE=Phatgirl2]How does the higher incident of seizures fit into this extended relief? [/QUOTE]

I don't know. I don't use Tramadol.........

Oh, well, thanks for the post. Very interesting.

I didn't experience any itching with Tramadol, but I do have it with the Vicodin. It's not the whole time or all the time even, but it seems to hit me when the potency of the drug is wearing off. Do you think I could possibly be building up antibodies? I would hate to have a bad reaction. That would suck...

I take ultracets... well the generic which on the bottle says tramadol.

So, what is the difference?

difference is Joonie, one is the generic of the other.ok so it is the same "drug" just one is a generic? I thought that. I even googled it, but when you google tramadol you do not see anything that says Ultracet. Or maybe I was not looking hard enough. It is a bit early in the morning for me LOL!

Ok... well then... if my insurance will pay for the extended release of this med, then that would be great for me!

My ultracets are RX to where I can take up to 8 a day. My RD done it like that so I can take them a lot in a day for when my pain is really really bad. It was so it would kinda be like "extended release" except I had to take them every couple of hours myself. I never took the maximum of 8 in a day... I think I only took 6 a day once or twice. That is way back when I was off the Remicade for a while and my upper thigh/hip/leg problem was bad.

I do well with extended release meds. Like the Coreg CR, it controlled my rapid pulse and BP much better than regular Coreg did, but my insurance will not pay for it unless it is PAed every 3 months, which sucks!