Clonicel. Sciele Pharma, a Shionogi Company based in Atlanta, GA, and Addrenex Pharmaceuticals, Inc., of Durham, SC, are working together to bring a long-acting version of Clonidine to the ADHD treatment regime. They have collaborated on the development of Clonicel, which is in Phase III clinical trials and has shown positive benefits in treating certain symptoms of ADHD, especially when combined with stimulant medications such as Ritalin.

According to the Addrenex Pharmaceutical website, “At the foundation of the long-term strategic positioning is the development of CLONICEL, the company’s lead product. CLONICEL is a patented extended release formulation of clonidine hydrochloride, a drug currently approved for hypertension but also used by clinicians for a large number of conditions related to hyperadrenergia, including ADHD. CLONICEL is being developed to address the unmet need in the marketplace for a longer lasting, better tolerated version of clonidine. Addrenex is pursuing indications in both hypertension (under the trade name Sympres) and ADHD (CLONICEL).”

According to the company’s press release celebrating the Phase III results, “Clonicel is a non-stimulant medication that selectively targets and calms the adrenergic system, a cascade of stress hormones that regulate the body's response to stress and other physiologic factors. An overactive adrenergic system can trigger emotional outbursts, irritability, mood swings and other debilitating symptoms.”

Over the years we have seen Clonidine prescribed to children with ADHD and temper problems, and have called it “a sledge hammer” approach to treatment, as it often just over-whelms a child. And we have never been impressed with Clonidine since we have seen the same benefits from Extress (VAXA International), but without the strong side-effects of Clonidine.

But that is not to say that there are not times with a “sledge hammer” approach isn’t needed, and it is certainly not to say that a better version of Clonidine could never be developed – and perhaps now it has been.

UPDATE

CNS therapies firm Aerial BioPharma launches $12M fundraising ...

www.medcitynews.com10/21/11

The company's lead drug candidate was Clonicel, a compound being developed as a treatment for hypertension treatment as well as attention deficit hyperactivity disorder. Although Addrenex raised no venture capital it did ...

Clonicel - Drugs.com

www.drugs.com10/2/09

Clonicel (modified-release clonidine) is a new drug in development for the treatment of attention deficit hyperactivity disorder. Clonicel information includes news, clinical trial results and side effects.

Addrenex Pharmaceuticals Announces Positive Phase III Clinical ...

www.medicalnewsblog.info9/13/08

The study showed that the new drug, Clonicel, achieved statistically significant improvement over placebo in reducing an aggregate of 18 ADHD symptoms listed by the American Psychiatric Association and used by physicians to diagnose and ...

Back in 2002 Roger Kurlan, M.D., of the University of Rochester Medical Center in New York, and others, found that the combination of clonidine (Catapres) and methylphenidate (Ritalin) were helpful in the treatment of ADHD and tics (Tourettes Syndrome). The team reported that Methylphenidate primarily improved focus and attentiveness, helping children stay "on task," and Clonidine helped to decrease the symptoms of hyperactivity and impulsivity.

This study had four groups: a placebo control group, a stimulant only group, a Clonidine only group, and a group that received both Methylphenidate and Clonidine. The study looked at both the ADHD symptoms and the TS (tic) symptoms. The report indicated that both the Methylphenidate only group and the Clonidine only group showed improvements over the placebo group, but the best results came from the combination group. However, the study also reported that about half the children who received Clonidine alone experienced the “sledge hammer effect” of sedation (drowsiness), which was the most common side-effect in this study.
Read the study here: http://www.ninds.nih.gov/news_and_events/news_articles/news_article_adhd...

The most recent Addrenex studies have shown that Clonicel (extended release clonidine) improved all of the symptoms of ADHD: inattention, hyperactivity, and impulsivity. “Clonicel was well tolerated and had a favorable safety profile, with mild adverse events such as drowsiness,” according to their press release.

You can learn more about Clonicel here: http://www.addrenex.com/PressR-ADHD-04-23-2009.pdf and here: http://www.addrenex.com/Addrenex-Press09-10-2008.pdf

If your child has ADHD with temper outbursts, or tics, we would still recommend a trial of Extress with your stimulant medication (or with Attend and/or your stimulant medication) first, and we would recommend our eating recommendations as often (but not always) temper outbursts are adverse reactions to eating certain foods or other environmental toxins. Should these recommendations fail to work, then ask your doctor about a combination of Clonicel and stimulant medications once Clonicel becomes available.

This book section: ADHD Medications

Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.

Christian Counselor counseling Tehachapi for ADHD, depression, anxiety, and more.

Douglas Cowan, Psy.D., MFT
27400 Oakflat Dr.
Tehachapi, CA 93561
(661) 972-5953