{"id":1679,"date":"2017-02-09T22:58:41","date_gmt":"2017-02-09T22:58:41","guid":{"rendered":"https:\/\/tris.sambrownprojects.com\/tris-pharmas-results-from-a-laboratory-classroom-study-of-dyanavel-xr-in-children-with-adhd-featured-at-apsard\/"},"modified":"2024-06-03T11:15:21","modified_gmt":"2024-06-03T10:15:21","slug":"tris-pharmas-results-from-a-laboratory-classroom-study-of-dyanavel-xr-in-children-with-adhd-featured-at-apsard","status":"publish","type":"post","link":"https:\/\/www.trispharma.com\/tris-pharmas-results-from-a-laboratory-classroom-study-of-dyanavel-xr-in-children-with-adhd-featured-at-apsard\/","title":{"rendered":"Tris Pharma\u2019s Results from a Laboratory Classroom Study of DYANAVEL\u00ae<\/sup> XR in Children with ADHD Featured at APSARD"},"content":{"rendered":"\r\n

Published on February 08, 2017<\/p>\r\n\r\n\r\n\r\n

MONMOUTH JUNCTION, N.J.,<\/strong> February 9, 2017 – Tris Pharma, Inc.<\/a> (\u201cTris\u201d) announced that results from a laboratory classroom study of DYANAVEL XR (amphetamine) extended-release oral suspension, CII, the first and only extended-release liquid amphetamine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged six years and older, were presented at the 2017 American Professional Society of ADHD and Related Disorders<\/a> (APSARD) Annual Meeting held in Washington, D.C. The study concluded that DYANAVEL XR was effective in reducing symptoms of ADHD from one to 13 hours after dosing in children aged six to 12 years, with a safety profile similar to other extended-release amphetamines.<\/p>\r\n\r\n\r\n\r\n

The findings were presented in a poster, \u201cThe Efficacy and Safety of Amphetamine Extended-Release Oral Suspension (AMPH EROS) in Children With ADHD,\u201d presented by Ann C. Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine, Las Vegas, NV. The presentation was selected by the APSARD organizers to be featured in the conference Poster Tour.<\/p>\r\n\r\n\r\n\r\n

\u201cIt\u2019s important to establish and maintain effective control of symptoms in children with ADHD,\u201d said Dr. Childress.\u00a0 \u201cThis study demonstrates the effectiveness of DYANAVEL XR in both onset of action at 1 hour post-dose, and a duration of efficacy extending to 13 hours post-dose.\u201d<\/p>\r\n\r\n\r\n\r\n

\u201cTris is committed to providing pediatric-friendly treatment options for children\u201d, said Sally A. Berry, M.D., Ph.D., Chief Medical Officer for Tris Pharma.\u00a0 \u201cThis work is evidence of our efforts to produce complete profiles of our pediatric products through robust research to inform clinical decision making.\u00a0 Doctors and their patients deserve no less.\u201d<\/p>\r\n\r\n\r\n\r\n

About the Study<\/strong><\/p>\r\n\r\n\r\n\r\n

The trial was designed as a dose-optimized, randomized, double-blind, placebo-controlled laboratory classroom study in patients aged six to 12 years with ADHD. The study enrolled 108 patients. Efficacy was assessed by school teachers and raters using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale, which is a standard tool that assesses behavior and attention in laboratory classroom studies.<\/p>\r\n\r\n\r\n\r\n

Key findings include:<\/p>\r\n\r\n\r\n\r\n

– DYANAVEL XR met its primary endpoint of change from pre-dose in the SKAMP-Combined score at 4 hours post-dosing (P<0.0001).<\/p>\r\n

\r\n\r\n<\/p>\r\n

– DYANAVEL XR also met key secondary endpoints by demonstrating an onset of clinical effect at one hour that persisted through 13 hours post-dosing compared to placebo.<\/p>\r\n

\r\n\r\n<\/p>\r\n

– DYANAVEL XR was well tolerated in this study, with a safety profile similar to other extended release amphetamines.<\/p>\r\n

\r\n\r\n<\/p>\r\n

DYANAVEL XR received approval from the U.S. Food and Drug Administration (FDA) in October 2015. Based on clinical trial experience with DYANAVEL XR, side effects appear to be similar to other once-daily ADHD medicines with the same active ingredient. The most common (\u22652% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6\u201312 years) were: epistaxis (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%).<\/p>\r\n

\r\n\r\n<\/p>\r\n

As is the case with other stimulant medications because of its potential for abuse, DYANAVEL XR is classified as a controlled substance (CII).<\/p>\r\n

\r\n\r\n<\/p>\r\n

About ADHD<\/strong><\/p>\r\n

\r\n\r\n<\/p>\r\n

ADHD is one of the most common neurobehavioral disorders characterized by an ongoing pattern of inattention and\/or hyperactivity\/impulsivity. These behaviors can interfere with functioning or development.1<\/sup> According to the Centers for Disease Control and Prevention\u2019s 2011 data, 11 percent of children aged four to 17 years in the U.S. have received an ADHD diagnosis at some point in their life.2<\/sup><\/p>\r\n

\r\n\r\n<\/p>\r\n

IMPORTANT SAFETY INFORMATION AND INDICATION<\/strong><\/p>\r\n

\r\n\r\n<\/p>\r\n

INDICATION<\/strong><\/p>\r\n

\r\n\r\n<\/p>\r\n

DYANAVEL\u00ae<\/sup> XR (amphetamine) extended-release oral suspension is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).<\/p>\r\n

\r\n\r\n<\/p>\r\n

IMPORTANT SAFETY INFORMATION<\/strong><\/p>\r\n

\r\n\r\n<\/p>\r\n

\r\n

WARNING: ABUSE AND DEPENDENCE<\/strong><\/p>\r\n

CNS stimulants, including DYANAVEL XR, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.<\/strong><\/p>\r\n<\/div>\r\n

\r\n\r\n<\/p>\r\n