Intuniv TM and Vivanse

Shire Pharmaceuticals has invested heavily in developing medications for the treatment of ADHD in both children and adults. While Vivanse has become an option for many prescribing physicians and parents, they also have new medications “in the pipeline” to bring to the ADHD market.

In a recent press release Shire pointed out that a study published in the journal Child and Adolescent Psychiatry and Mental Health found that Vivanse (lisdexamgetamine dimesylate), with its once a day dosing, significantly reduced the symptoms of ADHD in children ages 6 to 12 throughout the day and dose. The benefits were measured 90 minutes after taking the medication, and again throughout the day, up to 13 hours later. Benefits were seen in behavior and attention at each time point measure, even up to 13 hours after taking the medication.

This means that one dose, administered at home before school, would benefit the child not only during the school hours, but even back at home while doing homework, playing with friends, or at other activities. Vivanse is the only ADHD stimulant medication that can claim to have benefits up to 13 hours after taking the medication.

Shire plc has also received a notice from the FDA, called a “complete response letter,” regarding INTUNIV TM (guanfacine) extended release formula. The purpose of the letter is to try to work out the labeling language issues that have to be finalized prior to taking the medication to market for ADHD. Shire hopes that the issues can be resolved by the fall of 2009.

When INTUNIV TM is brought to the market, it will be the first selective alpha-2A receptor agonist for the treatment of ADHD in children ages 6 to 17. INTUNIV will be a once a day dose, extended release formula of guanfacine. Shire reports that INTUNIV is not a controlled substance and has no known potential for abuse or dependence.

According to Shire, Guanfacine, the active ingredient in INTUNIV, is thought to work directly by binding selectively to alpha-2A adrenergic receptors located in the prefrontal cortex an area of the brain that has been linked to ADHD. Stimulation of the postsynaptic alpha-2A receptors is thought to strengthen working memory, reduce susceptibility to distraction, improve attention regulation, improve behavioral inhibition and enhance impulse control.

Guanfacine is better known as Tenex, which is primarily a blood pressure medication. It is also helpful in some cases with Post Traumatic Stress Disorder treatment. Researchers were pleased to find that it helped with many of the symptoms of ADHD, and applied to the FDA for use in the treatment of ADHD back in the summer of 2007.

Side effects include: Dizziness, drowsiness, headache, constipation, gas pains, diarrhea, loss of appetite, fatigue, and nasal congestion may occur. More rarely one may experience chest pain, shortness of breath, skin rash, swelling of the hands or feet, blurred vision, yellowing of the eyes or skin. More serious side effects include mental/mood changes, tingling of the hands or feet, dry mouth, impotence, decreased sexual desire, vision changes, taste changes, ringing in the ears, leg cramps. Cardiovascular side effects include orthostatic hypotension, dizziness, palpitations, and tachycardia upon standing, and possibly bradycardia. Rebound hypertension is a possibility with abrupt discontinuation, and as such a gradual discontinuation is recommended.

While both of these medication will benefit many children, teens, and adults with ADHD, we would still recommend considering a trial of more natural means of treating ADHD before turning to the medications with their potential side effects. We would recommend using our ADHD eating program for 30 to 60 days, and also during that time trying Attend and either Extress or Memorin. Should this fail to provide the desired benefits, then a trial of medications would certainly be reasonable.