Navigation Links
Addrenex Pharmaceuticals Reports Positive Results in Second Phase 3 Study of ADHD Medication
Date:4/23/2009

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 www.addrenex.com.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:9/28/2017)... Sept. 28, 2017 Cohen Veterans Bioscience and ... use of wearable and home sensors for real-time monitoring ... Signal Foundation, a nonprofit organization focused on disruptive health ... an affordable analytical system to record and integrate behavioral, ... ...
(Date:9/25/2017)... R.I. , Sept. 25, 2017  EpiVax, ... assessment, vaccine design, and immune-engineering today announced the ... on the development of personalized therapeutic cancer vaccines. ... has provided exclusive access to enabling technologies to ... Eng., MBA will lead EpiVax Oncology as Chief ...
(Date:9/19/2017)... -- HistoSonics, Inc., a venture-backed medical device company developing a non-invasive, robotically assisted, platform therapy ... team developments today:   ... ... Tom Tefft ... Veteran medical device executive Josh Stopek , PhD, who has led R&D ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... , ... The American Board of Family Medicine's (ABFM) Board of Directors has ... succeeding Dr. James C. Puffer upon his retirement. Dr. Newton will serve in the ... at the end of 2018. Upon assuming the role of President and CEO on ...
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder ... of ElderCounsel, a national organization of elder law and special needs planning attorneys. “Membership ... rules. It also provides a forum to network with elder law attorneys nationwide,” said ...
(Date:10/13/2017)... ... , ... Ellevate Network, the leading network for professional women, brought together some ... at their inaugural Summit in New York City in June. The event was livestreamed ... over 3 million. To watch the Mobilize Women video, click here . ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader ... been awarded a contract by the Center for Medicare and Medicaid Services (CMS). ... the enterprise use of Agile methodologies in a consistent and high value manner ...
(Date:10/12/2017)... ... 12, 2017 , ... CitiDent and San Francisco dentists, Dr. ... Oventus O2Vent technology. As many as 18 million Americans are estimated to suffer ... Oral appliances can offer significant relief to about 75 percent of people with ...
Breaking Medicine News(10 mins):