PARIS and NEW YORK, Dec. 23, 2014 /PRNewswire/ -- NeuroLifeSciences announced today groundbreaking data from its open-label pilot study of mazindol in children with attention deficit/hyperactivity disorder published in Drug Design, Development and Therapy in December 2014.
The paper, titled "Pilot Phase 2 study of mazindol in children with attention deficit/hyperactivity disorder" (Konofal et al, Drug Des Devel Ther. 2014 Dec 1;8:2321-2332. eCollection 2014 ) shows that mazindol might be an effective, well-tolerated, and long-acting agent for the treatment of ADHD in children.
Twenty-one subjects (aged 9 - 12 years) were observed. After 1 week of mazindol administration, all children were clinically responders to mazindol. A significant reduction in the ADHD composite score was observed both by investigators and parents. In addition, the CPRS-R:L score indicates significant change in the level of symptomatology of ADHD after mazindol withdrawal. Adverse events were mild to moderate, decreased appetite and upper abdominal pain being the most common. Cardiac function and ECG measurements remained unchanged. Previous long-term studies in other indications have shown that neither tolerance nor dependence develop during treatment.
Current treatment options do not adequately meet patients need as the first line treatment for ADHD mainly relies on the use of psychostimulants such as methylphenidates, amphetamines, along with the nonamphetaminelike stimulant modafinil.
These stimulant medications are classified as Schedule II controlled substances because of their potential for dependence and abuse.
"These data, published today in Drug, Design Development and Therapy, are a significant step for patients calling for safer and more-effective alternatives in the treatment of ADHD, both in children and adults," said Eric-Jean Desbois, President of NeuroLifeSciences Inc.
"The data suggest, for the first time, that there is room in ADHD therapeutics for an effective non-amphetaminic stimulant medication, without the undesirable effects attributed to stimulants. Experts' unanimous support of such advancement renders this the most critical unmet clinical need in ADHD," said Eric Konofal, MD/PhD Chief Medical Officer of NeuroLifeSciences and inventor of the mazindol treatment in ADHD.
These data published today, although collected from a small number of patients, are compelling and demonstrate the potential of mazindol a wake-promoting agent developed in the 1960s with an outstanding, long-term safety profile addressing game-changing unmet medical needs, which would be a shift of paradigm.
Attention Deficit Hyperactivity Disorder (ADHD) is a group of behavioral symptoms that include inattentiveness, hyperactivity and impulsiveness.
The worldwide prevalence, for those under the age of 18, is estimated to be 5.3% to 12% (Am J Psych. 2007). In the US, approximately 6.4 million people under the age of 18 have been diagnosed with ADHD at some point in their lives. It is estimated that well over 10 million adults in the US have ADHD.
ADHD Treatment market value to rise with a Compound Annual Growth Rate (CAGR) of 5.3%. ADHD therapeutics market value will rise from $ 6.9 billion in 2013 to $ 9.9 billion by 2020, with broadening diagnostic criteria a key driver of growth.
NeuroLifeSciences SAS ( NLS ) – NLS is an emerging biotech company established in 2013 and headquartered in Paris, France, with a subsidiary in New-York, USA. The scientific groundwork was laid in 2004 when co-founder Dr. Eric Konofal, a sleep disorder specialist and key opinion leader for ADHD, started to patent his break-through ideas. NLS is primarily focusing on the repurposing of safe and (cost-)effective compounds to treat Attention Deficit/HyperActivity Disorder (ADHD), sleep disorders and cognitive impairment.
NLS develops innovative therapeutic solutions and prioritizes its work based on unmet medical needs, strong scientific understanding of neurobehavioral and neurocognitive disorders and their pharmacognosia.
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