Vayarin® Plus has been studied in a multi-center, double-blind, placebo controlled, randomized clinical study with 180 adults with ADHD.

CLINICAL STUDY RESULTS

IMPROVES GLOBAL ADHD BEHAVIORS AND INATTENTION

Vayarin® Plus was clinically shown to improve global ADHD behaviors, as well as inattention in ADHD patients

MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, SEQUENTIAL PARALLEL COMPARISON DESIGN (SPCD) TRIAL (8 wks) N=189; AGED 18-60 ADMINISTERED EQUIVALENT OF 2 CAPSULES VAYARIN® PLUS (450 mg) PER DAY

IMPROVED BRIEF-A TASK MONITORING

Reflects the ability to keep track of one’s problem-solving success or failure and identify and correct mistakes.

Vayarin® Plus was clinically shown to improve task monitoring behaviors in ADHD patients

CLINICAL STUDY DESIGN

The Vayarin® Plus study design was chosen to minimize placebo response commonly observed in studies of various neurological conditions.

STUDY DESIGN (SPCD* MODEL)

VAYARIN® PLUS WAS SUCCESFUL IN SHOWING IMPROVEMENT IN GLOBAL ADHD BEHAVIORS IN THE TOTAL POPULATION VS PLACEBO

*sequential parallel comparison design

SAFETY

VAYARIN® PLUS WAS SHOWN TO BE SAFE & WELL TOLERATED WITH A SIDE EFFECT PROFILE EQUIVALENT TO PLACEBO

Vayarin® Plus should be taken by adults & adolescents over the age of 14, who weigh above 97lbs/44kgs.

*Adverse events reported during the two phases of the clinical trial (total of sixteen weeks), which were judged by the study physicians as related or possible related to the study treatment
**Numbers are based on total numbers of patients who received placebo or Vayarin® Plus at some point during the trial

 

Our patented PS-Omega-3 structure was tested in a preclinical study and shown to be superior in increasing the bioavailability of Omega-3 in brain tissue compared to control and common Omega-3 products: fish oil, phosphatidylserine (soy-PS), and soy-PS added to fish oil.

BIOAVAILABILITY

IN ANIMAL MODEL, PS-OMEGA-3 SIGNIFICANTLY INCREASED BIOAVAILABILITY TO THE BRAIN

Significant increase of 42% in Omega-3 bioavailability in the brain versus control

*p<0.05 compared to control, based on one-way ANOVA
Vaisman N, et al., Prog Neuropsychopharmacol Bio Psychiatry 2009;33:952-959.