Vyvanse (lisdexamfetamine dimesylate) was approved by the FDA in February for the treatment of ADHD in children, and is finally available in pharmacies. Tonight, Shire is presenting its official introduction of Vyvanse to physicians in a live webcast called "ADHD Thursday Night Live."I don't know a huge amount about Vyvanse yet. I do know that Vyvanse is the molecule dextroamphetamine (trade names Dexedrine and Dextrostat) attached to the amino acid lysine. Shire cleverly calls it "lisdexamfetamine," presumably on the theory that using an "f" instead of "ph" in the chemical name will make it less obvious that Vyvanse is simply a fancified version of good old Dexedrine, a mainstay of ADHD treatment of decades.
At any rate, Vyvanse is an inactive “pro-drug” which has no pharmacologic effect until after it is absorbed through the GI tract into the bloodstream, when liver and gut enzymes cleave off the lysine portion and produce the active drug d-amphetamine. The requirement that lysine be lopped off delays the peak concentration of d-amphetamine, but not by very much. To give you a sense of the scale that we are talking about, Dexedrine, which is pure dexamfetamine (I'm using Shire's Newspell here) reaches its peak concentration at 3 hours after administration (see Dexedrine prescribing information, accessed at http://www.fda.gov/cder/foi/label/2006/ 017078s040lbl.pdf). Vyvanse reaches its peak concentration at 3.5 hours, a delay of 30 minutes. While classified as a Schedule II controlled substance like existing stimulants, Vyvanse produces no high if snorted, and a 100 mg dose made drug abusers less buzzed than a 40 mg dose of Dexedrine. However, at 150 mg of Vyvanse there were no differences between the two on the “drug likeability scale.” (See the manufacturer’s Web site at http://www.vyvanse.com/.)
Over the past 2 weeks in my private practice office I have received 9 different mailings from Shire about Vyvanse, an average of about one every other day, but I expect the pace to pick up significantly. Today, my Vyvanse mailing invited me to a "virtual roundtable series" to "provide feedback on various support materials that Shire provides physicians to help them better understand...Vyvanse." In other words, Shire has invited me and thousands of other physicians to be marketing consultants. No compensation was mentioned, but I was provided with the following number to register: 1-800-635-8730, program 2595. Readers are invited to do their own research on this opportunity.
I'll keep you updated on future promotionals as they flood into my office. This should be interesting, as Shire is the most aggressive pharmaceutical marketer I've ever seen, and they are not shy about using CME programs to promote their products.
At any rate, Vyvanse is an inactive “pro-drug” which has no pharmacologic effect until after it is absorbed through the GI tract into the bloodstream, when liver and gut enzymes cleave off the lysine portion and produce the active drug d-amphetamine. The requirement that lysine be lopped off delays the peak concentration of d-amphetamine, but not by very much. To give you a sense of the scale that we are talking about, Dexedrine, which is pure dexamfetamine (I'm using Shire's Newspell here) reaches its peak concentration at 3 hours after administration (see Dexedrine prescribing information, accessed at http://www.fda.gov/cder/foi/label/2006/ 017078s040lbl.pdf). Vyvanse reaches its peak concentration at 3.5 hours, a delay of 30 minutes. While classified as a Schedule II controlled substance like existing stimulants, Vyvanse produces no high if snorted, and a 100 mg dose made drug abusers less buzzed than a 40 mg dose of Dexedrine. However, at 150 mg of Vyvanse there were no differences between the two on the “drug likeability scale.” (See the manufacturer’s Web site at http://www.vyvanse.com/.)
Over the past 2 weeks in my private practice office I have received 9 different mailings from Shire about Vyvanse, an average of about one every other day, but I expect the pace to pick up significantly. Today, my Vyvanse mailing invited me to a "virtual roundtable series" to "provide feedback on various support materials that Shire provides physicians to help them better understand...Vyvanse." In other words, Shire has invited me and thousands of other physicians to be marketing consultants. No compensation was mentioned, but I was provided with the following number to register: 1-800-635-8730, program 2595. Readers are invited to do their own research on this opportunity.
I'll keep you updated on future promotionals as they flood into my office. This should be interesting, as Shire is the most aggressive pharmaceutical marketer I've ever seen, and they are not shy about using CME programs to promote their products.
3 comments:
I have been taking 30mg Vyvanse for a couple of weeks after a 50 year life of frustrated inability to concentrate on any one thing for very long. It's effect was almost immediate. The downside is that I miss the comic nature of my bouncing brain...my friends and family do not. if nothing else, the mess that is my life now has become painfully apparent. I don't feel completely overwhelmed, but close. i don't understand the medical communities willingness to prescribe speed and not opiods. from my memories of my parents medicine cabinet...not much has really changed since the sixties. It's all just an educated guess with usually inconsistant or worse results, at least for me.
I really do not care what marketing the companies do as long as the medication does what it says it can do. I have been fighting my insurance company for 9mo to get Vyvanse approved as it was the only medication the worked for me for the short time I was on it.
I was on Concerta, Ritiln, and Adderall XR - They all gave me major side effects like serious cramping and abdominal pain, panic attacks & anxiety, to crashes around 3-4pm when I need to be alert with 3 little kids coming home from school.
Because of my fight to try to get the medication covered, I lost custody of my children temproarily as my ex hisband if saying that my "mental health" is not well managed.
So can you please explain to me that the ONLY medication that worked for me, I can not even get? And not to mention that Ido not have to worry about it's addictive qualities.
That's really a shame, anonymous. A medication that could help you to be healthier in mind and body, not to mention keep your family intact, and you can't get it.
Yet, our religion-infused Bush administration is doling out millions and millions of dollars to "faith-based" marriage initiatives carried out by lay people. Yet how many "marriage problems" are caused by brain disorders that remain untreated because community mental health clinics have gone the way of the dodo bird. My guess is, a huge percentage of them.
Leave it up to the grandstanding Grassley and his ilk--so blindly supported by comments elsewhere on this blog--and your insurance will never cover any modern delivery method for your stimulant medication. (Besides, they make so much more money when the insured pay a premium for the higher-cost meds.)
It's just amazing to me. White House staffers are some of the most powerful members of Congress, though they work behind the scenes with their own undisclosed interests. Yet no one questions Grassley's staffers and their motives. Talk about naive!
No one can convince me that Grassley's big insurance-company campaign donor has nothing to do with his crusade against psychiatric researchers and the medications they show to be effective.
Anyone who swallows his office's hype without question probably believed the "smoking gun" in Iraq, too. And look where that got us.
Yes, some pharma reps spook me, too. I've observed docs shortly after reps have gotten to them, and they look like they're fresh out of an an Amway marathon. Scary!
But for people like you and many others, Vyvanse (or Concerta or Daytrana or....) will be the only thing that works. So, we have to remember that behind the reps and the icky marketing moves are scientists who really do care and who've devoted their lives to helping people improve their lives.
Good luck,
Gina
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