| Sciele Pharma, a Shionogi Company based in | | | | of Clonidine could never be developed - and |
| Atlanta, GA, and Addrenex Pharmaceuticals, Inc., | | | | perhaps now it has been. |
| of Durham, SC, are working together to bring a | | | | Back in 2002 Roger Kurlan, M.D., of the University |
| long-acting version of Clonidine to the ADHD | | | | of Rochester Medical Center in New York, and |
| treatment regime. They have collaborated on the | | | | others, found that the combination of clonidine |
| development of Clonicel, which is in Phase III | | | | (Catapres) and methylphenidate (Ritalin) were |
| clinical trials and has shown positive benefits in | | | | helpful in the treatment of ADHD and tics |
| treating certain symptoms of ADHD, especially | | | | (Tourettes Syndrome). The team reported that |
| when combined with stimulant medications such | | | | Methylphenidate primarily improved focus and |
| as Ritalin. | | | | attentiveness, helping children stay "on task," and |
| According to the Addrenex Pharmaceutical | | | | Clonidine helped to decrease the symptoms of |
| website, "At the foundation of the long-term | | | | hyperactivity and impulsivity. |
| strategic positioning is the development of Clonicel, | | | | This study had four groups: a placebo control |
| the company's lead product. Clonicel is a patented | | | | group, a stimulant only group, a Clonidine only |
| extended release formulation of clonidine | | | | group, and a group that received both |
| hydrochloride, a drug currently approved for | | | | Methylphenidate and Clonidine. The study looked |
| hypertension but also used by clinicians for a large | | | | at both the ADHD symptoms and the TS (tic) |
| number of conditions related to hyperadrenergia, | | | | symptoms. The report indicated that both the |
| including ADHD. Clonicel is being developed to | | | | Methylphenidate only group and the Clonidine only |
| address the unmet need in the marketplace for a | | | | group showed improvements over the placebo |
| longer lasting, better tolerated version of clonidine. | | | | group, but the best results came from the |
| Addrenex is pursuing indications in both | | | | combination group. However, the study also |
| hypertension (under the trade name Sympres) | | | | reported that about half the children who received |
| and ADHD (Clonicel)." | | | | Clonidine alone experienced the "sledge hammer |
| According to the company's press release | | | | effect" of sedation (drowsiness), which was the |
| celebrating the Phase III results, "Clonicel is a | | | | most common side-effect in this study. |
| non-stimulant medication that selectively targets | | | | Read the study here: |
| and calms the adrenergic system, a cascade of | | | | The most recent Addrenex studies have shown |
| stress hormones that regulate the body's | | | | that Clonicel (extended release clonidine) improved |
| response to stress and other physiologic factors. | | | | all of the symptoms of ADHD: inattention, |
| An overactive adrenergic system can trigger | | | | hyperactivity, and impulsivity. "Clonicel was well |
| emotional outbursts, irritability, mood swings and | | | | tolerated and had a favorable safety profile, with |
| other debilitating symptoms." | | | | mild adverse events such as drowsiness," |
| Over the years we have seen Clonidine | | | | according to their press release. |
| prescribed to children with ADHD and temper | | | | If your child has ADHD with temper outbursts, or |
| problems, and have called it "a sledge hammer" | | | | tics, we would still recommend a trial of Extress |
| approach to treatment, as it often just | | | | with your stimulant medication, or with Attend |
| over-whelms a child. And we have never been | | | | and/or your stimulant medication first, and we |
| impressed with Clonidine since we have seen the | | | | would recommend our eating recommendations |
| same benefits from Extress (an over the counter | | | | as often (but not always) temper outbursts are |
| product), but without the strong side-effects of | | | | adverse reactions to eating certain foods or other |
| Clonidine. | | | | environmental toxins. Should these |
| But that is not to say that there are not times | | | | recommendations fail to work, then ask your |
| with a "sledge hammer" approach isn't needed, | | | | doctor if a combination of Clonicel and stimulant |
| and it is certainly not to say that a better version | | | | medications might be right for your situation. |