CHARLOTTE, N.C., Feb. 11, 2010 -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that a new investigator-led phase II clinical study of Droxidopa, an oral synthetic precursor of norepinephrine, in combination with carbidopa has been initiated in adult attention deficit hyperactivity disorder (ADHD).
ADHD is a neurobiological disorder characterized by lifelong issues of inattention, distraction, organizational difficulties, forgetfulness, restlessness, and other disruptive behavioral issues. ADHD is the second most common neuropsychiatric disorder affecting 4.4% of the U.S. adult population, or between 8-9 million individuals. As adult ADHD is characterized as a disorder of decreased norepinephrine (NE) activity in the pre-frontal cortex, it is hypothesized that by limiting the peripheral metabolism of Droxidopa into NE through co-administration of carbidopa, the enhanced central levels of Droxidopa may have a positive therapeutic effect in adult ADHD.
This single-center Phase II study designed to evaluate the effect of Droxidopa therapy on adult ADHD symptoms is being conducted by the Narrows Institute for Biomedical Research in New York. Following six weeks of open-label treatment with Droxidopa and carbidopa, approximately 20 patients will be randomized into a two-week double-blind, placebo-controlled period. The primary outcome measure will be changes from baseline in total score on the Adult ADHD Investigator Symptom Rating Scale (AISRS). Secondary measures include changes in ADHD symptoms on the Adult Self-report Symptom Scale (ASRS) and global impairment on the Clinician Global Impression Scale (CGI).
"Droxidopa is a promising investigational drug that, when paired with carbidopa, is believed to promote increased NE levels in the central nervous system," stated Dr. William Schwieterman, Chelsea Therapeutics' Chief Medical Officer. "Since the neurotransmitter norepinephrine is critical to the proper functioning of the areas of the brain responsible for concentration and sustained attention, there is a strong theoretical basis supporting the potential therapeutic benefit of Droxidopa and carbidopa and we are pleased to support the initiation of the first clinical trial of this combination in ADHD."
"Supporting investigator initiated studies will help us further understand the breadth of potential therapeutic applications of Droxidopa as we continue to focus our internal resources on the completion of our registration studies in neurogenic orthostatic hypotension," said Dr. Simon Pedder, president and CEO of Chelsea. "Researchers at the Narrows Institute are at the forefront of ADHD research. We welcome the opportunity to support their efforts and look forward to the valuable information that this study will generate regarding the safety and efficacy of Droxidopa in adult ADHD."
Droxidopa, the lead investigational agent in Chelsea Therapeutics' broad pipeline, is currently in Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure – a group of diseases that includes Parkinson's disease, multiple systems atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa is also being studied for the treatment of fibromyalgia in an ongoing phase II trial and completed a phase II in intradialytic hypotension (IDH) study with positive results.
About Chelsea Therapeutics
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, Droxidopa, is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Droxidopa, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX).
This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include our need to raise operating capital, our history of losses, risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates Droxidopa and CH-1504, reliance on collaborations and licenses, intellectual property risks, competition, market acceptance for our products if any are approved for marketing and reliance on key personnel including specifically Dr. Pedder.
CONTACT: Chelsea Therapeutics Investors: Kathryn McNeil 718-788-2856 email@example.com