has anyone here tried this before? if so, what were your experiences with it?

Shire Receives Approvable Letter From FDA for INTUNIV(TM) (guanfacine) Extended Release, a Nonstimulant for the Treatmen

Thursday, June 21, 2007 1:39:00 AM ET
PRNewswire

BASINGSTOKE, England and PHILADELPHIA, Pennsylvania, June 21 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that it has received an approvable letter from the US Food and Drug Administration (FDA) for INTUNIV (guanfacine) extended release tablets (previously referred to as SPD503), a nonstimulant selective
alpha-2A-receptor agonist, which has been studied in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Unlike some other ADHD treatments, INTUNIV, a nonstimulant, is not a controlled substance and does not have a known mechanism for potential abuse or dependence. The information requested by the FDA was not unexpected, and Shire is working with the FDA to provide a full and timely response to the agency's request.

"The FDA's approvable letter for INTUNIV is positive news, and Shire will
be working closely with the agency to address its questions," said Matthew
Emmens, CEO of Shire. "When approved, INTUNIV will be the first medication indicated to treat ADHD symptoms by selectively targeting alpha-2A-receptors in the prefrontal cortex, an area of the brain that is thought to manage executive functioning tasks. Shire is looking forward to further strengthening our broad portfolio of ADHD medications by adding a
nonstimulant treatment option with a novel mechanism of action and
demonstrated clinical efficacy, which may be ideal for those patients who
have not benefited from currently available ADHD medications."

About INTUNIV (guanfacine) Extended Release Tablets

Shire is seeking approval of INTUNIV as monotherapy for the treatment of
ADHD symptoms throughout the day in children aged 6 to 17 years, with dosage strengths of 1 mg to 4 mg daily. The INTUNIV New Drug Application (NDA) includes data from two placebo-controlled trials in children and adolescents ages 6 to 17 evaluating the compound's safety and efficacy in controlling ADHD symptoms evaluated on a once-weekly basis using the ADHD Rating Scale (ADHD-RS-IV), which included both hyperactive/impulsive and inattentive subscales. ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD in children and for assessing their response to treatment. 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). In these two clinical trials, treatment related adverse events greater than 10 percent included somnolence, fatigue, upper abdominal pain, sedation and headache.

INTUNIV, a once-daily formulation of guanfacine, provides a controlled,
steady delivery of drug throughout the day and evening with a delivery system that minimizes the fluctuations between peak and trough concentrations as seen with immediate-release guanfacine. It has been shown that guanfacine, the active ingredient in INTUNIV, binds selectively to alpha 2A adrenergic cell receptors located in the part of the brain called the prefrontal cortex.

The prefrontal cortex is an area of the brain associated with executive
functioning, i.e., working memory, behavioral inhibition, regulation of
attention, distractibility, impulsivity, and frustration tolerance. The
selective alpha-2A agonist strengthens working memory and prefrontal cortex neuronal firing. This research supports the use of guanfacine for the
treatment of ADHD.

(full article: http://www.newratings.com/analyst_news/article_1554379.html)

My youngest takes guanfacine (short acting form) and it helps with hyperactivity, impulsivity, defiance and sleep issues. She still needs a stimulant (lower dose) for the additional challenges of school.

does your youngest also have issues with inattention? Is that what the stimulant is for?

thanks for the info!

Short answer- she has inattention as well as behavior issues, and guanfacine helps a lot but not quite enough for the inattention.

Longer explanation - She has combined ADHD. We started with concerta and there was a point where she could use an increase in the stim but had started losing weight, so guanfacine was added to augment the concerta. This combo was great and she went from Ds and Fs to As and Bs. The only problem was that she did not gain any weight for 8 months and was very thin to start. We tried guafacine alone and it seemed really good for behavior and attention. After a few months she started having anxiety and we realized the guanfacine alone was pretty good but not quite good enough. When we added back a stim, it was focalin this time. For her focalin does not affect weight.

She is on guafacine and risperdal (for axiety and aggression) without a stimulant for the summer for max weight gain.