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Neurovance: ADHD and EB-1020

EB-1020, a Norepinephrine and Dopamine-Preferring Triple for ADHD

EB-1020 is a triple reuptake inhibitor that modulates norepinephrine (NE), dopamine (DA) and serotonin (5-HT) in a ratio of 1 to 6 to 14, respectively. This preferential NE with moderate DA reuptake inhibition profile, with a small amount of 5-HT reuptake inhibition, has the potential to be an effective treatment for ADHD in adults with less risk of  drug abuse liability and diversion than the stimulants used for ADHD today. A composition of matter patent from the US Patent and Trademark Office provides EB-1020 with proprietary protection through July 2026.

 

Objective: Improved Efficacy with Reduced Drug Abuse Liability

The pharmacology of EB-1020 suggests a profile similar to atomoxetine (the first non-stimulant approved for ADHD), but with an additional effect on DA.  This could improve attention and problem solving activity, as well as lead to a faster speed of onset and an improved cognitive profile. In a study conducted at Harvard by Frank Tarazi, Ph.D., EB-1020 showed positive results in an animal model for ADHD. While the DA neurotransmission brings important benefits in ADHD treatment, EB-1020 features moderate DA reuptake resulting in the potential for a lower risk of drug abuse liability than stimulants such as mixed amphetamine salts or methylphenidate used in the treatment of ADHD. Since these stimulants are frequently diverted for non-medicinal purposes, the Federal government exerts strong controls over these addictive medications.

 

Clinical Trials

In a phase 1 clinical trial evaluating single and multiple ascending doses of an immediate-release formulation of EB-1020 in healthy subjects, EB-1020 was well tolerated and safe across a broad dose range. Following that study, Neurovance developed sustained-release formulations of EB-1020 to improve dosing convenience for adults with ADHD.  A phase 1 “umbrella” study is evaluating the sustained-release formulation’s pharmacokinetics, food effects, and tolerability with multiple dose escalation in healthy volunteers. Results are expected in mid-2013, and a phase 2a pilot study in ADHD patients is planned for later this year.

 

Attention Deficit and Hyperactivity Disorder (ADHD)

ADHD is one of the most common childhood disorders and can continue through adolescence and into adulthood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and hyperactivity. ADHD causes significant impairment in adults, resulting in difficulty functioning, low educational attainment, underachievement in vocational and educational pursuits, and poor social and family relations. Approximately 10 million adults in the US have ADHD; however, only about one in ten adults with ADHD are treated. Contributing factors to the low treatment rate include a low rate of diagnosis and concerns by physicians to administer addictive stimulants to adults with ADHD, many of whom have co-morbid substance abuse.

  • ADHD, one of the most common mental disorders in children and adolescents, also affects an estimated 4.4% of adults, ages 18-44, in a given year (Kessler 2006). Using the current 310 million population (US Census 2011) this represents approximately 10 million Americans.
  • 41.3% of these people are classified as Severe. This represents approximately 1.7% of the adult population in the US or 4 million adults that are severely affected by ADHD.
  • The current US market for ADHD is estimated to be in the range of $7.9 billion. The prescription market is split nearly evenly between adults and children. The market for pediatric treatment is well established while the adult market has traditionally been under-recognized, though the prescription growth among adults is nearly twice that of children (IMS, 2011).

Current pharmacotherapy of ADHD is not comprehensive for treating all symptoms and several of the standard treatments are associated with drug abuse liability, non-medical diversion, and other side effects, such as insomnia, cardiovascular effects and weight loss. Historically, patients suffering from ADHD have been treated with psychostimulants (e.g. amphetamines and derivatives), although such medicines carry the risk of abuse. Three non-stimulants have been approved for ADHD: atomoxetine, a norepinephrine reuptake inhibitor and two alpha-2 adrenergic agonists, guanfacine and clonidine. However, among these non-stimulants only atomoxetine is approved for use in adults with ADHD.

 

Current non-stimulants do not have drug abuse liability and are not diverted but neither are they regarded as particularly effective. Stimulants are effective but they are strongly addictive and among certain populations, widely diverted. Thus, there is an opportunity for a non-stimulant with greater efficacy than first-generation non-stimulants but with less risk of abuse than current stimulants. This is the opportunity for EB-1020 for adult ADHD.

 

 

For additional information, please visit the National Institute of Mental Health website:  http://www.nimh.nih.gov/statistics//1ADHD_ADULT.shtml

Source: National Institute of Mental Health; Euthymics Bioscience