NRP104 has moved up the pipeline, and now has gotten an approvable letter from the FDA. It also has a real name now: lisdexamfetamine dimesylate. It is so new that it does not even have a Wikipedia page yet!
What is the point of this exercise? Do we really need another repackaged version of an old compound?
The answer is yes, but the reason depends on whom you ask.
Abuse of prescription stimulants is a bit of a problem.
By one
estimate (PDF link), about 5.9% of college undergranduates
will take stimulants that were not prescribed for them. How
much of that is enough of a problem to worry about is subject to
debate, but it indicates that there is a porblem.
Shire and their partner, New River Pharmaceuticals, have presented data showing there is less potential for abuse of lisdexamfetamine dimesylate, compared to dextroamphetamine. If that turns out to be the case on the street, so to speak, then it would be an improvement.
So if you ask clinicians if there is a need for a new compound, they would say there is. That is because no clinician wants to act as an enabler for someone else's substance abuse.
If you ask the pharmaceutical company, the answer is also yes. The patent for Adderall has run out. The other patented stimulants are running out of patent life. But if something new is going to make it to the market, it has to have some kind of selling point. A reduced potential for abuse could be just that.
But how different will lisdexamfetamine really be? The data presented by the company show that drug abusers do not like it as well as regular amphetamine. They also show that the blood level of the drug stops going up in proportion to the dose, at doses above 130mg. So, taking very high doses may not make up for the delay in attaining peak concentration.
There are other data avaiable, which are favorable as well. The University of Michigan Substance Abuse Research Center has on their site a PDF on the subject. On page 27, there is agraph showing that nasal insufflation (snorting) results in nearly undectable blood levels of dextroamphetamine, at least in rats.
Shire is hoping that the DEA gives the drug a rating lower than schedule II, but it is not yet know if that will be the case. The reason that is important, is that prescriptions for schedule II medications cannot be refilled, and prescriptions cannot be called in. It is a nuisance for all involved. Just getting rid of the nuisance factor would make the product more popular with doctors and patients. From the press release:
If some actual social good comes of it, so much the better. The thing is, it is difficult to know what the abuse potential really is, until the product has been on the market for a while. Personally, I suspect that they will get a favorable classification from the FDA, but that will be subject to change. If the product turns out to be abused widely, the FDA could reclassify it.
(As an aside for those who like the chemistry of this kind of molecule, Molecule of the Day has a post on the related compound, l-methamphetamine.)
Shire and their partner, New River Pharmaceuticals, have presented data showing there is less potential for abuse of lisdexamfetamine dimesylate, compared to dextroamphetamine. If that turns out to be the case on the street, so to speak, then it would be an improvement.
So if you ask clinicians if there is a need for a new compound, they would say there is. That is because no clinician wants to act as an enabler for someone else's substance abuse.
If you ask the pharmaceutical company, the answer is also yes. The patent for Adderall has run out. The other patented stimulants are running out of patent life. But if something new is going to make it to the market, it has to have some kind of selling point. A reduced potential for abuse could be just that.
But how different will lisdexamfetamine really be? The data presented by the company show that drug abusers do not like it as well as regular amphetamine. They also show that the blood level of the drug stops going up in proportion to the dose, at doses above 130mg. So, taking very high doses may not make up for the delay in attaining peak concentration.
There are other data avaiable, which are favorable as well. The University of Michigan Substance Abuse Research Center has on their site a PDF on the subject. On page 27, there is agraph showing that nasal insufflation (snorting) results in nearly undectable blood levels of dextroamphetamine, at least in rats.
Shire is hoping that the DEA gives the drug a rating lower than schedule II, but it is not yet know if that will be the case. The reason that is important, is that prescriptions for schedule II medications cannot be refilled, and prescriptions cannot be called in. It is a nuisance for all involved. Just getting rid of the nuisance factor would make the product more popular with doctors and patients. From the press release:
If NRP104 is approved with a Schedule III, IV or V classification or is unscheduled ("favorable scheduling"), Shire will pay New River a $300 million milestone payment. US operating profit will be divided as follows: Shire will retain 75 percent of profits for the first two years following launch, and the parties will share the profits equally thereafter.
In the event that NRP104 receives a final Schedule II classification, no milestone payment will be payable by Shire to New River upon approval. Division of profits will be calculated under an alternative profit sharing scheme.
If some actual social good comes of it, so much the better. The thing is, it is difficult to know what the abuse potential really is, until the product has been on the market for a while. Personally, I suspect that they will get a favorable classification from the FDA, but that will be subject to change. If the product turns out to be abused widely, the FDA could reclassify it.
(As an aside for those who like the chemistry of this kind of molecule, Molecule of the Day has a post on the related compound, l-methamphetamine.)
Comments
I don't think it indicates a problem when 5.9% of college undergranduates take stimulants that were not prescribed for them.
Clearly, NRP140 is not about reducing the abuse potential of methamphetamines, its about making money in a market that needs drugs.
Posted by: whitewhale | October 30, 2006 9:02 PM
There is some truth to that, but even if the benefit is only a perceived benefit, there is a practical advantage. If NRP104 gets a schedule III or IV classification, it will be a lot more convenient for doctors and patients. Granted, that is not what is motivating the companies that are working on it, but it is worth something.
Plus, there probably will be some people who tolerate it better that the existing product. Less anxiety, perhaps.
Posted by: Joseph j7uy5 | October 30, 2006 9:53 PM
As an ADHD patient, it would be wonderful to be able to get refills or have my physician call in a precription in an emergency (such as if either he or I were on vacation).
But as important as the accessibility factor is, the more important issue in my mind is dignity. It is difficult enough to go through life with a neurological disability. It is even more difficult when many otherwise educated and intelligent people believe that it does not exist, or that it is merely a lack of discipline...but to then be treated like a drug addict by my insurance company, to have pharmacists glance at the prescription and immediately announce that they don't have enough on stock to fill it...to essentially be persecuted for seeking treatment...
And then even when it is recognized that you have a legitimate medical need for treatment, there's still the attitude that I should be greatful to be allowed to receive the medication, as if I should just accept that the danger of other people getting high is clearly more important than whether I have the neurological function necessary to remain employed.
Yeah, I'd say a non-abusable version of dextroamphetamine would be a g_dsend. Is there any indication that they would make a d/l mixed-salt version (ie lis-Adderall), or only a dexedrine-style version (also, XR version or no?)?
Posted by: Hyperion | October 30, 2006 11:20 PM
I agree with the last post. It is a major pain to have to call in for this every month, fetch the paper prescription, and then get that 'look'. (I switched pharamcies so I don't get those looks anymore.)I struggled my whole life with ADD. Once I figured it out, and took my first dose, wow! I was finally like everyone else. (But I kept my quirky sense of humor.)
Ok, yes, there are people who are abusing it, and a true addict will find another drug to abuse if this one goes away, while 95% of us take it responsibly.
My question is this. How does this drug affect the liver's P450 system? I've looked for info about this, and can't seem to find any. (I have a blood disorder that originates in the liver.)
Posted by: Wendy | November 5, 2006 11:13 AM
I'm amazed that a patent was issued for Adderall, as it is merely a mixture of four amphetamine salts with different half-lives. Does Mars, Incorporated, get a new patent if they shift the distribution of colored M&Ms?
Posted by: Watt de Fawke | October 9, 2007 9:45 AM
I am just starting to find out how hard it is to fill the schedule II drug that I take for add
It works so well that I hate to change but not having to bother the doc and picking up the perscription every time would be good. Well here I go to start my journey on what works and what doesnt.
Posted by: len | August 9, 2009 12:28 PM