New ADHD drug | ADHD Information
There is no cure for ADHD, and since it is a brain chemical disorder, chances are there won't be.
I found the info on vyvanse from my DD's psych
Hey Soberxinsanity,
If you go to www.fda.gov you can find links to recalls, new approved meds, devices etc, new draft regulations and guidance documents, etc. If you go to www.clinicaltrials.gov you can information on trials for all kinds of things and then follow the company for press releases.
My job requires that I keep up with these things (not for ADHD). I run into all kinds of things when I am keeping up on draft or new regs or guidances, checking on clinical trials, etc.
vickie39145.8194907407vickie, since you seem to be very knowledgeable about thebehind-the-scenes of the FDA,firstly:where did you find the info? I'm always googling things but that doesnt help too much, I'd be curious to see the progress they are making with new meds.
what new meds are they anticipating for the future, are they looking for futire meds that won't be stimulants, and are they by any chance looking to cure ADD sometime in the future?
http://www.medicalnewstoday.com/medicalnews.php?newsid=63844 &nfid=crss
I'm sure many have seen the new drug made by Shire (the makers of Adderall)
I just read about the newest ADHD drug and I thought of something.
In the future, the drugs us ADHD'ers are taking will be considered old time medications. Im 19, and i bet ill tell my children.. "Hell, when i was your age, I had to take a pill to help my AdHd." They probably will say, Whats a pill? After they get their AdHd Vaccine or something! 
haha Something to think about.
I was wondering when they would anounce this. Shire still has to finish the acqusition of New River (the company that developed this new amphetamine form). A goal for these new forms is to get a stim that is not classified as a class II controlled substance and limit the potential for abuse.
Later this year Shire should also have thier exstended release guanfacine approved for ADHD as well. That one will not be a class II controlled substance.
Well I am kinda bummed that it will still be a schedule II classification..is there a possibility that it will move out of that rating after it is out on the market a few years? I mean if it is inactive unless taken orally.....it sure would be nice to not have to get that written script each month....edbson said:
"There is no cure for ADHD, and since it is a brain chemical disorder, chances are there won't be."
edbson, There isnt a cure for ADHD, this is true. However, I disagree that we won't find a cure for the treatment of ADHD. We don't know much about the brain yet.... Think about it
- Penicillin for instance. (antibiotic). It was found on accident! Nobody imagined during the time (1928) that bacterial infections could be cured. Amazingly enough, they were and still are with different forms of antibiotics branching from Penicillin.
Basically, and in my strong opinion; someday, we will know EXACTLY the cause of Attention Defeceit Hyperactivity Disorder and will open the door to medical methods in treating it. Right now, it's all theory, and that is why the disability is so debated.
bman3039160.0296990741I agree with bman...look at all the revolutionary procedures going on in the medical world..
as debated as it currently is, genetic engineering and stem-cell research may in the future be applied to ADHD, since ADHD has genetic components, as far as we know. I recently read about a study that was able to measure norep. and dopamine levels in the prefrontal cortex, showing that these levels were lower in ADHD subjects...that can lead to a huge breakthrough in drug designing for ADHD, because now they have a more concrete goal when designing new meds.
My hope is that one day stimulant meds will become the last-resort, if-all-else-fails treatment, and we will have something much better out there. And if the disorder really is neurological, it can lead to more breakthroughs for other neurological disorders like autism & PDDs, Parkinsons, etc.
OH YEAH?
Well one day, and maybe sooner than now, I will launch the greatest weapon against ADD/ADHD that will have Shire on their knees begging me to sell them rights... I just need a volenteer.
This is what I found on it, looks promising BTW.
Vyvanse
VYVANSE is a prodrug that is therapeutically inactive until metabolized
in the body. In clinical studies designed to measure duration of effect,
VYVANSE provided significant efficacy compared to placebo for a full
treatment day, up through and including 6:00 pm. Furthermore, when VYVANSE
was administered orally and intravenously in two clinical human drug abuse
studies, VYVANSE produced subjective responses on a scale of "Drug Liking
Effects" (DLE) that were less than d-amphetamine at equivalent doses. DLE is
used in clinical abuse studies to measure relative preference among known
substance abusers.
"The FDA approval of VYVANSE is exciting news for Shire as well
as for patients, their families, and healthcare providers as it's an
important, novel approach for the treatment of ADHD," said Matthew Emmens,
Shire Chief Executive Officer. "The label we received with the approval
letter includes information about the extended duration of effect and
abuse-related drug liking characteristics of VYVANSE which illustrate
benefits that differentiate this compound from other ADHD medicines. The
addition of VYVANSE to our ADHD portfolio reaffirms Shire's commitment to
continue to address unmet medical needs and advance the science of ADHD
treatment. Beginning with product launch in Q2 2007, Shire will make VYVANSE
our top promotional priority within our ADHD portfolio."
Randal J. Kirk, New River's Chairman and Chief Executive Officer,
remarked, "VYVANSE's approval signals a new era in the treatment of ADHD.
Upon product launch, patients will have a novel treatment option combining
the effectiveness of a stimulant - long considered the gold standard in ADHD
medicines - with other potential benefits."
The FDA has proposed that VYVANSE be classified as a Schedule II
controlled substance. This proposal was submitted to and accepted by the U.S.
Drug Enforcement Administration (DEA). A final scheduling decision is
expected from the DEA following a 30-day period for public comment. Once
VYVANSE receives final scheduling designation, the label will be available.
Pending final scheduling designation, product launch is anticipated in Q2
2007. VYVANSE will be available in three dosage strengths: 30 mg, 50 mg and
70 mg, all indicated for once-daily dosing.1
New River developed VYVANSE as a new ADHD medication designed to provide
lower potential for abuse, in which d-amphetamine is covalently linked to
l-lysine, a naturally occurring amino acid. The combination is rapidly
absorbed from the gastrointestinal tract and converted to d-amphetamine,
which is responsible for VYVANSE's activity.
Joseph Biederman, MD, director of Pediatric Psychopharmacology at
Massachusetts General Hospital, was lead investigator on the pivotal clinical
studies testing lisdexamfetamine dimesylate for the treatment of ADHD. These
large multi-site studies showed that the drug significantly reduced ADHD
symptoms throughout the day with a predictable tolerability profile. "Our
studies showed that this next-generation stimulant medication's unique
chemical profile offers an option for physicians and their patients in the
treatment of ADHD, with outstanding efficacy and duration of action" said Dr.
Biederman.
Additional information about VYVANSE and other Shire treatments for ADHD
is available at www.ShireADHDTreatments.com.
VYVANSE Significantly Controls ADHD Symptoms
Data from phase II and phase III clinical trials demonstrated
statistically significant improvements in ADHD symptoms for patients aged 6
to 12 years treated with VYVANSE compared to patients treated with placebo.
These studies demonstrated that all doses of VYVANSE (30 mg, 50 mg and 70 mg)
provided significant efficacy at all time points tested, including 6pm.2
In the phase II, analog classroom study, patients demonstrated
significantly improved behavior when receiving either VYVANSE or ADDERALL
XR(R) (mixed salts of a single-entity amphetamine product) as measured by the
Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment rating scale,
a standardized, validated classroom assessment tool used for evaluating the
behavioral symptoms of ADHD.3 Both treatments resulted in significantly
improved behavior versus a placebo (P <.0001, for both).4 Patients also
demonstrated significantly improved academic productivity with both
treatments, compared to placebo (P <.0001 for both medications) as measured
by Permanent Product Measure of Performance (PERMP), an age-adjusted
collection of math problems that measures a child's ability to pay attention
and stay on task as demonstrated by an increase in the number of attempted
and successfully completed problems.4
In the phase III, randomized, double-blind placebo-controlled
study, all three doses of VYVANSE demonstrated significant improvements in
ADHD Rating Scale (ADHD-RS-IV) scores compared with placebo (P <.0001) after
four weeks of once-daily treatment. 5 ADHD-RS-IV is a standardized, validated
test for assessing symptoms of ADHD in children and for assessing their
response to treatment.6,7 This scale, which contains 18 items, is based on
the ADHD diagnostic criteria as defined in the APA's Diagnostic and
Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(R), a
publication of the American Psychiatric Association. 8
Additionally, in a study presented in October at a major
scientific meeting, VYVANSE yielded a 60 percent improvement in the primary
rating scale scores for symptoms of ADHD in children aged 6 to 12 years who
received six months of treatment in an open-label phase III study. Results
also demonstrated that at 6 months, 95 percent of children taking VYVANSE
produced a "much improved" or "very much improved" rating on the Clinical
Global Impressions - Improvement score.9
WASHINGTON (AP) -- A new amphetamine-based drug to treat attention deficit hyperactivity disorder won federal approval Friday. It's harder to abuse than older stimulants, the manufacturer says.
The Food and Drug Administration approved Vyvanse, also known as lisdexamfetamine, agency spokeswoman Susan Cruzan said. The drug is made by Shire PLC.
Shire hopes the drug will extend its lucrative ADHD franchise once its top-selling Adderall XR begins facing competition from lower-priced generic versions in 2009. Shire plans to move patients from the older to the newer drug at the time, company spokesman Matt Cabrey said this week.
Shire said it tried to limit the drug's potential for misuse. It tested the drug on adults with a history of abusing stimulants to assess its "likeability." Results suggest the drug delays the onset and limits the intensity of amphetamine-like effects, the company said.
Vyvanse works by gradually releasing its active ingredient, d-amphetamine, after the drug has been swallowed and comes into contact with enzymes in the digestive tract.
Unless it's swallowed, Vyvanse remains inactive. Shire believes that will curtail its potential for abuse by users who snort or inject crushed pills.
Despite those measures, the Drug Enforcement Administration has proposed making Vyvanse a Schedule II drug, a class that includes cocaine, methadone, methamphetamine and other drugs with a high potential for abuse.
Other ADHD medicines, including Adderall and Ritalin, also are Schedule II drugs.
Vyvanse's label will bear a "black-box" warning, the government's strongest, Cruzan said. Details were not immediately available.
The label of Adderall XR bears a warning because of safety concerns related to amphetamine abuse as well as the risk of sudden death in patients with heart defects.
FDA approval of Vyvanse came the same week that the agency asked all manufacturers of ADHD drugs to warn patients and their parents of mental and heart problems associated with use of the medicines.
Britain's Shire said earlier this month it would spend roughly .6 billion to buy New River Pharmaceuticals Inc., the Radford, Virginia, company that originally developed Vyvanse.