Navigation Links
Addrenex Pharmaceuticals Reports Positive Results in Second Phase 3 Study of ADHD Medication

Study shows Clonicel(R) and stimulants combined provide greater improvement in symptoms than stimulants alone

DURHAM, N.C., April 23 /PRNewswire/ -- Addrenex Pharmaceuticals, Inc. today announced positive results from a second phase 3 trial of Clonicel demonstrating that the combination of Clonicel with stimulant medications provided statistically significant improvements in attention deficit hyperactivity disorder (ADHD) symptoms compared to stimulant use alone.

Clonicel is the company's lead compound in a pipeline of products that have shown clinical success in alleviating conditions arising from an overactive adrenergic system, the body's control center for regulating stress and a host of other physiologic functions. The Durham-based specialty pharmaceutical company is also developing drugs to treat hypertension, menopausal flushing and potentially insomnia, pain, and migraines.

Based on the positive data from two Phase 3 trials conducted on Clonicel, Addrenex plans to seek approval from the U.S. Food and Drug Administration later this year for Clonicel as both a monotherapy and as an add-on therapy to stimulant medication for children and adolescents with ADHD. The North American rights to market Clonicel are licensed to Sciele Pharma, a Shionogi Company, which is an Atlanta-based specialty pharmaceutical company.

"Our data from the first phase 3 study strongly suggest that Clonicel is an effective therapy for ADHD when used alone, and now we have evidence from a second study that Clonicel also has a complementary effect when used with stimulants," said Moise Khayrallah, Ph.D., CEO of Addrenex Pharmaceuticals. "In children who are not receiving optimal benefit from stimulants such as methylphenidate or amphetamine, Clonicel may provide greater relief than using a stimulant medication alone."

The current study of 200 children with ADHD is the second phase 3 trial in a year to investigate the safety and efficacy of Clonicel, a long-acting version of clonidine hydrochloride. Both studies demonstrated that Clonicel improves an aggregate of 18 ADHD symptoms recognized by the American Psychiatric Association and used by doctors to diagnose and classify ADHD in children and adolescents.

In both studies, Clonicel showed improvement across all three symptom domains of ADHD; attention, hyperactivity, and impulsivity. Clonicel was well-tolerated and had a favorable safety profile, with mild adverse events such as drowsiness. The multi-center, placebo-controlled, double-blind, randomized trial was funded by Addrenex Pharmaceuticals.

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. Scientists have hypothesized that the adrenergic system is overactive in a subset of children with ADHD. Adrenergic dysregulation also may play a major role in a host of adult conditions such as post-traumatic stress syndrome, menopausal flushing, hypertension, and migraines.

About Addrenex

Addrenex specializes in the development of drugs, diagnostic tools and intervention methods aimed at normalizing adrenergic function and thereby helping patients regain control of symptoms related to adrenergic dysregulation. Adrenergic dysregulation is the root cause or major contributing factor for multiple medical conditions. Currently, Addrenex has three products in clinical trials and a library of over 400 compounds available for future development. For more information go to

SOURCE Addrenex Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Addrenex Pharmaceuticals Initiates Phase 2 Trial on Its Novel Hypertension Drug, ADX415
2. Addrenex Pharmaceuticals Announces Positive Phase III Clinical Results for Clonicel to Treat ADHD
3. Addrenex Pharmaceuticals New Hires Further Company Goal to Identify New Drugs for Adrenergic Regulation
4. NovaBay(R) Pharmaceuticals Enters into Agreement to Broaden Intellectual Property Estate and Expand Clinical Opportunities for Its Aganocide(R) Compounds
5. Peregrine Pharmaceuticals Reports Positive Preliminary Data From Phase II Bavituximab Lung Cancer Trial
6. Trubion Pharmaceuticals, Inc. Announces Upcoming Presentation at the 2009 American Association of Cancer Research Annual Meeting
7. VentiRx Pharmaceuticals Initiates Phase I Clinical Trial of VTX-1463, a Novel TLR8 Agonist for the Treatment of Allergic Rhinitis
8. Osprey Pharmaceuticals U.S.A., Inc. Initiates Phase Ib Clinical Trial in IgA Nephropathy
9. Optimer Pharmaceuticals Receives Production Patent for Lead Product Candidate Fidaxomicin
10. Raptor Pharmaceuticals Appoints Dr. Patrice P. Rioux as Chief Medical Officer
11. Strativa Pharmaceuticals Provides Product Pipeline Update
Post Your Comments:
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical ... the "Company"), which develops, markets and sells medical devices ... , signed a strategic cooperation agreement with Hongyuan ... "Hongyuan Supply Chain") on June 20, 2016, to develop ... the strategic cooperation agreement, Dehaier will leverage Hongyuan Supply ...
(Date:6/24/2016)... Belgium , June 24, 2016 /PRNewswire/ ... announced the appointment of Dr. Edward Futcher ... a Non-Executive Director, effective June 23, 2016.Dr. Futcher ... and Nominations and Governance Committees.  As a non-executive ... provide independent expertise and strategic counsel to VolitionRx ...
(Date:6/23/2016)... 23, 2016 Research and Markets ... Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic ... Coating, Parenteral) - Global Forecast to 2021" report ... The global pharmaceutical excipients market is projected to ... of 6.1% in the forecast period 2016 to 2021. ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, ... at Work award to iHire in recognition of their exemplary accomplishments in worksite health ... annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic ... many turn to unhealthy avenues, such as drug or alcohol abuse, as a coping ... released tools for healthy coping following a traumatic event. , Trauma sufferers tend to ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary ... Dallas that it will receive two significant new grants to support its work ... marked its 25th anniversary by recognizing patients, medical professionals and scientists for their ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is ... Road To Recovery® program to drive cancer patients to and from their cancer treatments. ... the highest quality of life and ongoing independence. Getting to and from medical ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine presented its first-ever ... Medicine conference in Ponte Vedra Beach, FL. The awards honor the outstanding work ... Practice and Pediatric Emergency Medicine Practice. , “With this award, we recognize ...
Breaking Medicine News(10 mins):