INTUNIV is a once-daily, extended-release formulation of guanfacine hydrochloride (HCl) in a matrix tablet formulation for oral administration only. The chemical designation is N-amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride.
INTUNIV is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications. The efficacy of INTUNIV was studied for the treatment of ADHD in three controlled monotherapy clinical trials (up to 8 weeks in duration) and one controlled adjunctive trial with psychostimulants (8 weeks in duration) in children and adolescents ages 6-17 who met DSM-IV criteria for ADHD [ ]. The effectiveness of INTUNIV for longer-term use (more than 8 weeks) has not been systematically evaluated in controlled trials.
see Clinical Studies
Media Articles Related to Intuniv (Guanfacine)
Shire receives European approval for INTUNIV as a non-stimulant ADHD treatment for children and adolescents
Source: ADHD / ADD News From Medical News Today [2015.09.21]
Shire has announced that the European Commission granted Marketing Authorisation for once-daily, non-stimulant INTUNIV® (guanfacine hydrochloride prolonged release tablets) for the treatment of...
Hypertension Affects VTE Too
Source: theheart.org | Medscape Cardiology Headlines [2015.11.19]
Dr Goldhaber discusses some changes we may see in the incidence of MI, stroke, DVT, and PE if the medical community were to accept and adopt the new blood pressure targets studied in SPRINT.
theheart.org on Medscape
Hypertension Management After SPRINT: Fast Forward or Pause?
Source: theheart.org | Medscape Cardiology Headlines [2015.11.18]
Dr Clyde Yancy leads a panel discussion on the practice implications of the SPRINT findings suggesting a more stringent blood pressure target with Drs Bittner, Curtis, and O'Gara.
theheart.org on Medscape
Emricasan Shows Benefit in Portal Hypertension (CME/CE)
Source: MedPage Today Gastroenterology [2015.11.18]
(MedPage Today) -- Post-hoc analysis suggests severe disease should be the target
International Conference on Hypertension & Treatment, August 04-06, 2016, Toronto
Source: Conferences News From Medical News Today [2015.11.13]
OMICS International announces the International Conference on Hypertension & Treatment to be held during August 04-06, 2016 at Toronto, Canada, focusing on "Hypertension and Treatment" with a view...
Published Studies Related to Intuniv (Guanfacine)
Efficacy of guanfacine extended release assessed during the morning, afternoon,
and evening using a modified Conners' Parent Rating Scale-revised: Short Form. 
attention-deficit/hyperactivity disorder (ADHD)... CONCLUSIONS: These results provide further support for the demonstrated efficacy
Randomized, double-blind trial of guanfacine extended release in children with
attention-deficit/hyperactivity disorder: morning or evening administration. 
CONCLUSIONS: GXR administered either in the morning or evening was associated
Naltrexone with or without guanfacine for preventing relapse to opiate addiction
in St.-Petersburg, Russia. 
induced craving and have reduced opiate relapse in small clinical trials... CONCLUSIONS: Adding guanfacine to naltrexone did not improve treatment retention
Guanfacine extended-release: in attention deficit hyperactivity disorder. [2010.09.10]
Guanfacine, an alpha(2A)-adrenoceptor agonist, is available in the US as an extended-release (ER) tablet for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents (aged 6-17 years). In two large, randomized, double-blind, placebo-controlled trials of 8 and 9 weeks' duration, guanfacine ER (1-4 mg once daily) was effective in reducing the symptoms of ADHD (hyperactivity, impulsivity and inattention) in children and adolescents...
Effects of guanfacine extended release on oppositional symptoms in children aged 6-12 years with attention-deficit hyperactivity disorder and oppositional symptoms: a randomized, double-blind, placebo-controlled trial. [2010.09.01]
CONCLUSIONS: In this population of children aged 6-12 years with ADHD and the presence of oppositional symptoms, significant reductions in CPRS-R:L oppositional subscale and ADHD-RS-IV total scores were observed with guanfacine XR treatment compared with placebo. Treatment with guanfacine XR at optimized doses was associated with mostly mild or moderate TEAEs. The findings of this study support the efficacy of guanfacine XR in the treatment of children with ADHD and the presence of oppositional symptoms. Clinical Trial Registration Number: NCT00367835.
Clinical Trials Related to Intuniv (Guanfacine)
Efficacy of Intuniv Extended Release as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD [Recruiting]
This study looks to examine whether or not INTUNIV extended release can help children aged
6-12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) in improving
Executive Function when added to their usual care stimulant therapy. Executive functions
are a set of mental processes that include emotional control, planning, organization,
working memory, inhibition of behaviors, and managing time and space. As children with ADHD
usually have difficulties with Executive Function, and Executive function difficulties lead
to more difficulties in school and behaviour, it is anticipated that adding INTUNIV extended
release to usual stimulant therapy will improve Executive Function scores as rated by
parents and teachers. Improvements in quality of life will also be measured.
PK/PD Comparison of Guanfacine ER and IR [Active, not recruiting]
Evaluate whether a 4mg/day or 6/mg day dose of extended-release guanfacine produces
pharmacokinetic/dynamic (PK/PD) properties similar to 3mg/day immediate release guanfacine.
Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder [Recruiting]
Children with explosive aggression are often rejected by their peers, placed in special
classroom, and contribute to family discord. When psychotherapy and family therapy is
unsuccessful, medications are often used. Current medications are stimulants (e. g.
methylphenidate, dextroamphetamine), anticonvulsants (e. g. Divalproex) and antipsychotics
(olanzapine, risperidone). At this time, the available medications are of limited
usefulness, either because they do not always work or because they have side effects such as
weight gain or insomnia. There is a clear need for new medications to treat explosive
aggression when psychotherapy is unsuccessful.
The hypothesis of this study is the medication Intuniv when combined with psychotherapy will
be more helpful to children with explosive aggression than placebo combined with
psychotherapy. Intuniv is a long acting form of guanfacine, a medication approved by the FDA
for treatment of Attention Deficit Hyperactivity Disorder. Intuniv is not a stimulant, nor
is it an anticonvulsant, nor is it an antipsychotic.
The children in this study will be between the ages of 6 and 12 and meet Diagnostic and
Statistical Manual of Psychiatry Fourth Edition, Text Revision (DSM-IV-TR) criteria for
Intermittent Explosive Disorder.
Efficacy and Safety Eval of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults (18-65). [Completed]
This is considered an investigator-initiated clinical research trial, which means that your
study doctor is researching a particular medication (in this case a medication that is
currently FDA- approved) for the treatment of AD/HD in individuals ages 6-17. The medication
is guanfacine hydrochloride.
The hypothesis is that this medication could be used in adults with Attention
Deficit/Hyperactivity Disorder who have not received satisfactory results with their current
stimulant ADHD medication. The study drug is investigational for use in adults.
Investigational means it has not been approved by the U. S. Food and Drug Administration
(FDA) for use in adults.
Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder [Completed]
The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself
or in combination with methylphenidate (also known as Ritalin) is helpful for treating
hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).
Reports of Suspected Intuniv (Guanfacine) Side Effects
OFF Label USE (7),
Loss of Consciousness (6),
Inappropriate Schedule of Drug Administration (6),
Convulsion (6), more >>
Page last updated: 2015-11-19