Modafinil (Provigil, and formerly named "Attenance" in trial data for the ADHD indiction) has received an "Approvable" letter from the FDA based on positive phase III trials. Loose ends need to be tied up with the manufacturing details before it gets the final letter approval. It's expected to hit shelves first quarter 2006. Here's a link: Cephalon Investor Relations (http://phx.corporate-ir.net/phoenix.zhtml?c=81709&p=irol-newsArticle&ID=771069&highlight=)

I've raised the idea (1 (http://www.addforums.com/forums/showthread.php?t=18279&highlight=modafinil) and 2 (http://www.addforums.com/forums/showthread.php?t=18446&highlight=modafinil)) of a new folder for this one a few months ago (as well as a different structure), but it looks like the demand for a designated area for discussion of Sparlon will be needed increasingly in the not too distant future.

(BTW, guanfacine/Tenex (dubbed SPD-503 in trials), a drug I suggested as another important addition to the medication section, is in pre-registration (finished phase III trials) for an ADHD indictation as we speak. Official NDA filing expected 1st quarter '06. It's being developed and funded by Shire (aka. Adderall). Shire, in combination with a smaller firm, is also developing another amphetamine product (dubbed NRP104), which is also in pre-registration. The new amph is cojugated to the amino acid lysine which prevents abuse. It should be the first non- C-II amphetamine.)

This is awesome news! A new and novel addition to the ADHD pharmacopeia! There's already a good size population who have had success with this drug off-label and swear by it. With the official indictation the price will go down (although I'm sure it'll still be very expensive), and perhaps more importantly it will be much easier to coax insurance companies into covering it. It will spark research on the physiology of it's novel mechanisms and how it's unique profile contributes to the brain's ability to coordinate functions, maintain arousal and wakefulness, etc. It may help clarify subtype differences in the ADHD condition based on differential response. The prospects are positive for many areas of neuropsychopharmacology, as well as for patients on the clinical side.

I'm not entirely sure what section to post this in: It can relate to Forum Suggestions, General Medication, or Current Events/News. Thus, I'll put it in the general section so it gets the widest viewing, and moderators can do with it what you will :).

Anyways, good things on the horizon :D

Any idea of the starting price of the new version of Provigil? Several months ago my Doc thought it would come out at a price comparable to name-brand Adderall? Which is still cheaper than the $7.00+ price for Provigil for narcolepsy.

Thanks.

I took 200mg Provigil for about a week and felt like a complete idiot - it was almost to the point where I couldn't articulate anything, or even carry on a conversation. Unfortunately, I had an interview while on it - I'm still waiting to hear back, but I'm thinking I blew it. :( It was a dream job, too.

Later!

Cephalon expects to launch SPARLON, a proprietary dosage form of modafinil, in early 2006 subject to final FDA approval.I wonder what the "proprietary dosage form" is. Don't tell me it's some kind of weird release tablet that can make it as expensive as Concerta.

I wonder what the "proprietary dosage form" is. Don't tell me it's some kind of weird release tablet that can make it as expensive as Concerta. The phase III study involved dosages from 170-450mg. The "proprietary dosage" is just a dosage that works best for treating ADHD based on the studies. Some will need lower dosages, some higher, but the flexibility of 100 and 200mg is apparently not good enough. There's some truth to that, but really they are doing this to push it through the approval process and make marketing easier.

NB. Canada's patent laws are shorter than America's. You may be able to get an RX med sooner/cheaper here via mail-order pharmacy. (This is re: all drugs.)

Emma

The phase III study involved dosages from 170-450mg. The "proprietary dosage" is just a dosage that works best for treating ADHD based on the studies. Some will need lower dosages, some higher, but the flexibility of 100 and 200mg is apparently not good enough. There's some truth to that, but really they are doing this to push it through the approval process and make marketing easier. "Dosage form" seemed different from "dosage" for me, however.

Does anyone have more information on the progress of this medication? My doctor refused to prescribe Provigil. Maybe this approval would help. Are there many adverse side effects with Provigil? I've tried Adderall and had depressive reactions. I am now on Strattera, which is increasing axiety, but helps with focus. Strattera has had a lot of negative press, so I wonder why it's considered "safe". I think it's just because it's not a control and they had samples. Too bad this is the way doc's pick scripts.

I'm waiting for 5-10 years til i try Strattera. I mean, looks what happened with Serzone, Baycol, etc. Who needs Liver problems?

Dexedrine has been used since the 1930s. It works for me. It ain't perfect -- but it works less violently than Ritalin. (eg holy head explosion)

NB. Despite the fact that i find Dexedrine totally un-abusable orally, I realize it is so hard for most of you to get, due to idiots who misuse it. :( Guess we just need to keep "educating our doctors...."

in all fairness, we do owe a debt of gratitude to amphetamine abusers in one respect. their decision to make themselves into guinea pigs by regularly ingesting high doses of amphetamines has provided us with hoards of information on the effects of this drug. i mean, it would be ethically impossible to give human volunteers megadoses of antidepressants or anti-psychotics or anti-seiure meds to see what happens, but thanks to these abusers, we do have that data for amphetamines and other stimulants.