Intuniv: One Step Closer To FDA Approval for ADHD
ByThirty percent of children with AD/ADHD cannot tolerate taking stimulant medications.
For these individuals, the recent news that Shire is one step closer to gaining FDA approval for its time-released non-stimulant INTUNIV is welcome news.
Intuniv provides a 24-hour evenly released dose of the medication guanfacine. Specifically, guanfacine improves the symptom of the inability to concentrate in children with ADD/ADHD.
When given in conjunction with stimulants, it may also help reduce the aggression and the insomnia normally associated with the use of these drugs.
In fact, some physicians already prescribe it – in an immediate release version and under various brands – to their patients with ADD/ADHD along with other medications. The most common brand used is Tenex. This medication, however, appears not to be very effective at alleviating either the attention deficit or the distractibility seen in children with ADD/ADHD.
Two advantages of INTUNIV
Manufactured and marketed as INTUNIV, though, this form of the medication would hold two distinct advantages over what is currently being used. First, it would be approved specifically for the treatment of ADD/ADHD. And secondly – and most importantly to those whose concentration is low – it would relieve the unevenness produced by the immediate-release version of guanfacine.
Guanfacine works well in improving concentration, but it only lasts several hours, and once the medication wears off attentiveness wanes again.
Recent clinical trials conducted as part of the FDA approval process show that INTUNIV is extremely effective at boosting concentration levels consistently for a 24-hour period
The data the FDA scrutinized included the pooled analysis of results from two double-blind trials. Both of these studies used the teacher based ADHD Rating scale as the criteria for improvement.
One group of children received INTUNIV for the other group received a placebo which contained no medication.
All groups which received the medication scored significantly better in the rating scale than those who received the placebo.
The studies also examined the length of time the medication was effective for these children. Assessments were made at 12, 14 and 24 hour periods following the administration of this drug. Again the data showed significant improvement in the concentration of the children at each of these points in time.
Mild and moderate side effects of INTUNIV
Between 75 and 80 percent of the children, did display mild adverse side effects while taking INTUNIV, most of which appeared within the first two weeks and eventually tapered off. These seemed to be dose-related and included: upper abdominal pain, constipation, dizziness, hypotension, sedation, dry mouth, and drowsiness.
The most common of these side effects were related to sedation.
The medical community has been examining guanfacine for its effectiveness since 2001. That year a study appeared in the American Journal of Psychiatry showing that guanfacine to be a safe and effective treatment for children with ADHD and those who suffer with tic disorders.
The medication, according to the journal article, produced a mean improvement of 37 percent in the total score on teacher-rated ADHD Rating Scale following eight weeks of treatment. This was compared to the eight percent improved for those who received the placebo.
INTUNIV is not a controlled substance — as stimulants are — and does not appear at this time to carry any risk for either potential for abuse or dependence.
The FDA has issued an “approval letter†for INTUNIV, which means that it is prepared to approve the new drug application as soon as certain conditions are met, such as any requests for additional information.
How guanfacine works
Guanfacine works, according to Shire, by acting indirectly on the prefrontal cortex of the brain. Located directly at the very front of the brain and directly below the forehead, the prefrontal cortex controls what are known as the executive functions. This includes the resolution of conflicting thoughts, the choices involved in “right or wrong†and “good and bad†decisions, as well as the prediction of future events.
This section of the brain also governs social control that is it is the area used when we suppress or emotional urges.
Guanfacine is a selective alpha-2A-agonist medication.
Admittedly, the treatment of ADD/ADHD is a highly individualized challenge. Discovering the most effective combination the proper medications and other forms of therapy may mean attempting to use several medications in various combinations as well as varying doses. What is appropriate for one child or adult, may not be either appropriate or effective for another.
Nearly 8 percent of all school-aged children have been diagnosed with ADD/ADHD, according to the U.S. Centers for Disease Control and Prevention. While not normally thought of as a disorder affecting adults, some 4.4 percent of all adults, ages 18 to 44 are affected.
The major characteristic of ADD/ADHD is an inattention or hyperactivity-impulsivity that exceeds those normally observed in most individuals. Official diagnosis of this disorder can not be made until the symptoms have been observed for at least six months.
References:
Pro-drug gets attention,
http://www.sciam.com/article.cfm?id=pro-drug-gets-attention, accessed 11 Jun08
Guanfacine, http://www.depression-guide.com/guanfacine.htm, accessed, 7 Jun 08
Intuniv reduces ADHD symptoms, http://www.realmentalhealth.com/adhd/adhd_toc.asp, accessed 6 Jun 08
Shire Investigational Nonstimulant INTUNIV Showed Significant Efficacy In Reducing ADHD Symptoms, http://www.medicalnewstoday.com/articles/106801.php, accessed 10 Jun 08.
What is prefrontal cortex?, http://www.wisegeek.com/what-is-the-prefrontal-cortex.htm, accessed, 11 June 08
Larry Scahill, M.S.N., Ph.D., Phillip B. Chappell, M.D., Young S. Kim, M.D., Robert T. Schultz, Ph.D., Lily Katsovich, M.S., Elizabeth Shepherd, M.A., Amy F.T. Arnsten, Ph.D., Donald J. Cohen, M.D., and James F. Leckman, M.D. A Placebo-Controlled Study of Guanfacine in the Treatment of Children With Tic Disorders and Attention Deficit Hyperactivity Disorder, http://ajp.psychiatryonline.org/cgi/content/abstract/158/7/1067, accessed 11Jun08
Technorati Tags: Intuniv, Shire, ADHD, ADD, ADHD Medication, ADD Medication
I have a seven year old son with ADHD and ODD, also explosive anger issues. I switched him from Vyvanse to Intuniv about 2 months ago because of side effects caused by Vyvanse. The intuniv does not seem to be effective on his impulse control…he’s 60 pounds and taking 2 mgs. Should I try a higher dose or maybe a low dose of vyvanse combined with the intuniv?
Intuniv: Blood pressure medication for ADHD/ ADD people! STUPID!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Let me just say one thing what happens when you take medicine you don’t need for your heart????? You create a problem later in life. Unless you have a heart problem don’t take this med for ADD/ADHD med!!!!! Don’t be like Micheal Jackson taking meds you don’t need people. If your kid is crazy and have anger problems, spank there butt!!! ADD Is a half way impossible thing to pin point. notice everyone is ADD these days? Hmmmmm I think not.
Maggie, you are so clueless and ignorant, I don’t even know where to begin my comment. Yes, dealing with an ADD/ADHD/ODD/OCD/Aspergers child is just to spank them. Wow, you figured it all out-how could WE not think of that?! Please, get a clue and refrain from berating parents/caregivers who deal with these debilitating issues on a daily basis.
Maggie, please dont comment on ADHD if you have no personal experience with it – it is extremely challenging to say the least. We’re all looking for solutions not criticism. If you have valid concerns or opinions about the negative side affects of Intuniv, or better yet, a positive alternative, then certainly say so, but please do it without insinuating that ADHD is caused by parents who are not repremanding their children – that is insulting.
Thank you SO much!!! I’ve been searching hard core for a non stimulant alternative and this sounds PERFECT for my child!!! I think you just answered my prayers! lol. Thank you so much!
About a month or two ago we started considering Intunive because our son was having negative emotional reactions to various stimulant medications. We tried going off medications completely but his grades dropped and teachers were calling because he is unable to focus. We were keeping our fingers crossed that intunive would be the solution. The first week he took 1mg (which wasnt quite enough), second week 2mg (which worked better but made him a little drowsy), third week 3mg, which was too much. 3mg caused severe drowsinees and daily headache, but his attitude and focus was good. We went back to the 2mg dose and he is doing so much better, not drowsy any more either. He is focused, happy, his personality is back, we can communicate with him, and we are thrilled!! Definitely worth trying if you have similar frustraions with stimulants. Good luck!
My daughter has been on the 2 mg dose for the school year. She has ADD without the hyperactivity. Her issues are mostly focus but she also has OCD and Tourette’s. She has made straight A’s this year as compared to barely passing last year. I will say that we are starting to see the medication not be as effective. Her handwriting is getting worse, she is making focus-related errors in math, and has spurts of impulsive behavior. She is getting close to 70 lbs so maybe we just need to up her dose. She does have side effects. She gets frequent headaches and stomach issues. These were worse when she was starting the medicine or the two times she missed a dose. We have opted to take the summer off just to see where she is at. We’ve been told that as we reduce her dose and ween her off, the side effects may be bad again. It’s definitely not one to stop cold turkey. My daughter does not want to come off. She says it really helps her. We will probably go back on in August. We are having her tested for PANDAS as her tics and OCD have cycled with two strep infections and a bought with whooping cough.
My 11-year old son (ADHD) has been taking Intuniv 2 mg for the last 4 or 5 months. It worked very well until about the last month or two. I have started seeing more outbursts and hyperactivity again. I just started with a new Dr, as we moved to a new state. I suggested he had gained a small amount of weight and maybe the dosage should be upped to 3 mg. He said weight should have nothing to do with it??? Also, the only side effect I have noticed is the bedwetting as well. It happens occasionally. My Dr. is suggesting Strattera, but I would like to see if maybe taking Intuniv at different times will help. We tried the stimulants and that was an aggressive nightmare. Please let me know if anyone has any input.