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Positive Results Reported for Non-Stimulant Therapy (EB-1020 SR) in Adults With ADHD

Medication shows stimulant-like efficacy

Positive results have been reported from a phase IIa pilot study of EB-1020 SR (Neurovance, Inc.), a non-stimulant, in adult male patients with all subtypes of attention deficit hyperactivity disorder (ADHD).

The new data showed a statistically significant improvement in ADHD symptoms on the ADHD-Rating Scale-IV (ADHD-RS-IV) — the study’s primary outcome measure — in a range similar to that reported in previously published trials with stimulants. The results were presented at the 69th Annual Scientific Meeting of the Society of Biological Psychiatry, being held May 8–10 in New York.

EB-1020 SR is a norepinephrine- and dopamine-preferring triple reuptake inhibitor with IC50 values for human transporter reuptake inhibition of 6 nM, 38 nM, and 83 nM for norepinephrine, dopamine, and serotonin, respectively.

The new pilot study was designed to evaluate EB-1020 SR as a novel non-stimulant treatment option for adults with ADHD. A total of 41 adult males with well-characterized ADHD enrolled in the 4-week, single-blind study with a 1-week placebo run-in. EB-1020 SR was administered twice daily and titrated over 1 week to a target daily dose of 500 mg. Assessed outcomes included ADHD symptoms, executive functioning, and tolerability. A total of 37 subjects completed the trial.

EB-1020 SR produced a 21-point reduction on the ADHD-RS-IV (endpoint mean score = 17; P < 0.0001), including significant reductions in inattentive and hyperactive/ impulsive symptoms (both P < 0.0001). Overall, 68% of the subjects were considered responders (much/very much improved) using the Clinical Global Impression–Improvement scale. Clinically and statistically significant improvements (P < 0.0001) were also observed in overall and specific domains of executive function using the Behavioral Inventory of Executive Functioning (BRIEF-A).

ADHD is a disease of inattention, impulsivity, and hyperactivity. In addition, adults with the disorder often experience difficulty with executive dysfunction and emotional dysregulation (e.g., rage and mood swings).

An effective treatment for adult ADHD has to address the patient’s lack of focus, inattention, and disorganization, as well as his or her impaired executive function. Stimulants can be effective in this regard, but they can be abused. These drugs can also be diverted to non-medical uses and can cause adverse effects, such as sleeplessness and weight-loss. Because of the potential for abuse, stimulants are highly regulated as Schedule II controlled substances.

Non-stimulant medications, such as Strattera (atomoxetine, Lilly) — a norepinephrine reuptake inhibitor — are not controlled substances. Nonstimulants, however, generally have significantly less efficacy compared with stimulant medications.

According to the drug’s developer (Neurovance, Inc.), EB-1020 SR has its most potent effect on norepinephrine. It also moderately increases dopamine activity. This is believed to improve efficacy by improving attention and problem-solving activity, as well as potentially leading to a faster speed of onset and improved cognition.

The level of dopamine activity associated with EB-1020 SR is both lower and slower (slower to peak concentration [Tmax]) than that of stimulants. It is thought that this might reduce the risk of abuse and diversion. EB-1020 SR features a modest effect on serotonin, which is intended to help relieve the anxiety and depression that may accompany ADHD.

According to the most recent data from IMS Health, the U.S. ADHD prescription market for adults is now larger than that for children, with 30 million and 29 million total prescriptions, respectively.

Sources: Neurovance, Inc.; May 8, 2014; and EB-1020 SR; 2014.

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