- Sep 2, 2008
Lacosamide (above) is a new pharmaceutical being put out by the belgian pharmaceutical company UCB under the name "Vimpat." It works by enhancing slow inactivation of Na channels. To read more, go to Wikipedia.
I don't think I've mentioned it here before, but when the DEA published the notice of proposal to place Lacosamide in Schedule V, I filed a comment asking for it to not be scheduled. I'm pretty sure I was one of the only people to even file a comment. I don't know if you realize this, but everyday citizens are able to file comments, and even more: they get read. What's more is that everyday citizens are able to ask for public hearings to be held; this is what I did. I filed the formal paperwork to this end on Apr 30 or May 1. Unfortunately, this means that UCB has been prevented from putting their drug on the market, which as I'm told, would have happened the first week of May. Apparently, it may be held up for as long as a year. This means that if I fail, and the drug is scheduled anyway, I will have epileptics from obtaining a needed drug for no reason. If I win, I'll have made access easier, and I think be the first person to have done so. I might even be the first person to have challenged the scheduling of a new drug using this process.
The process may be a useful tool to prevent the scheduling (or lower the scheduling) for any number of potentially scheduled drugs.
In order to assess the potential abuse liability of lacosamide three dedicated animal studies were
1) Drug discrimination study a group of drug-naïve rats were trained to discriminate between ip injections of vehicle (physiological saline) and 10 mg/kg of lacosamide while responding under a fixed-ratio 10 schedule of food reinforcement. Consistent with the weak nature of the stimulus effects of lacosamide, the time taken to achieve discrimination with it (59.0 ± 4.2
training sessions) was longer than has been reported for establishing two-choice discrimination with the comparison substances used in the present study (Carter et al, 2004, Bartoletti et al, 2000, Mori et al, 2002). In the subsequent generalization testing, lacosamide itself, diazepam, morphine, phencyclidine and phenobarbital were tested for generalization to the lacosamide stimulus. When lacosamide itself was tested, the pattern of responding was best described as random, underlining the difficulty the rats had reliably to distinguish lacosamide from saline. The generalization
studies with the comparison substances with known abuse and dependence liability are consistent with the weak lacosamide discriminative cue as the pattern of responding was essentially random at all doses. In conclusion, the discriminative stimulus produced by lacosamide in rats was not robust, nor clearly dose-dependent suggesting that the test substance is not likely to have subjective effects leading to abuse in man.
2) Further, lacosamide was investigated after oral (gavage) administration in the conditioned place preference test in the rat; morphine hydrochloride was used as reinforcing drug, and the vehicle was used as negative control. Contrary to morphine, lacosamide did not affect the time spent in the drug-paired compartment during the test session as compared with the vehicle
control. The number of crossing was not affected.
3) Furthermore, when lacosamide was compared to cocaine and physiological saline for its ability to maintain intravenous self-administration in rats, it didn’t demonstrate to maintain self-administration at all doses tested.
These results suggest that lacosamide is not likely to have positive reinforcing properties or abuse potential. The evaluation of the dependence potential of lacosamide
I've been told by one of the people UCB had call me that the whole basis for scheduling is based on a few people who reported euphoria during the human trials stage of its development. There are many unscheduled pharmaceuticals that actually are addictive and reinforcing; tramadol, primidone and carisoprodol, for three quick off-the-top-of-my-head drugs.
As such, if I fail and it is scheduled, I will have delayed epileptic's access to a needed medication for no reason. I have to be especially prepared. If anyone is familiar with any research into any facet of issues related to abuse and dependence and lacosamide, I'd be especially interested. I believe I have combed the literature pretty well now, but it's very possible that I've missed something important.
I would like some information on what I need to know before this hearing, I'd be appreciative. I know this part doesn't really belong in ADD, but if I can get good answers to both aspects of it in one thread, that'd be best. Anyway, what can and can't I do? For instance, am I able to introduce expert testimony on the issue? I mean, if I had a PhD who was familiar with addiction and abuse, would I be able to ask him to comment on the risk this drug poses, ask questions, etc?