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FDA Approves Dyanavel XR

Tris Pharma Receives FDA Approval of Dyanavel XR (amphetamine) Once-Daily Liquid for ADHD in Children

MONMOUTH JUNCTION, N.J., October 20, 2015 -- Tris Pharma, Inc. ("Tris") announced that the U.S. Food and Drug Administration ("FDA") has approved Dyanavel XR (amphetamine), extended-release oral suspension, CII, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years and older. With this approval, Dyanavel XR becomes the only once-daily, extended release amphetamine-based oral liquid approved for the treatment of ADHD in children.

The approval is based on a Phase III randomized, placebo-controlled, laboratory classroom efficacy study conducted in 108 children (ages 6 to 12 years, who met DSM-IV® criteria for ADHD). The study, which included a 5-week, open-label, dose optimization followed by a 1-week, double-blind treatment period, demonstrated a positive outcome by meeting its primary endpoint of change from pre-dose in the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP)-Combined score at 4 hours post-dosing. 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. The most common adverse reactions ( ≥ 2% in the Dyanavel XR group and greater than placebo) reported in the study were: epistaxis (nose bleed), allergic rhinitis and upper abdominal pain.

Tris developed Dyanavel XR using its patented LiquiXR™ technology, a delivery system comprised of both immediate-release and extended-release amphetamine. By utilizing ion exchange polymeric chemistry, continuous release of amphetamine was achieved throughout the day.

"Dyanavel XR is the first and only once-daily, extended-release amphetamine oral suspension for the treatment of ADHD" said Sally Berry, MD, PhD, Chief Medical Officer of Tris. "Amphetamines are well-established as effective treatment for ADHD. Dyanavel XR offers physicians a new pediatric-friendly dosing option that couples fast onset with a long duration of effect suitable for school-aged children."

"Tris Pharma is dedicated to addressing unmet medical needs through developing non- traditional oral extended release formulations including oral suspensions, chewable tablets, and oral disintegrating tablets," said Ketan Mehta, President and CEO of Tris Pharma. "We are excited to receive FDA approval to commercialize Dyanavel XR, the 6th NDA approval in six years utilizing proprietary technology of Tris Pharma. We look forward to making Dyanavel XR available to physicians and patients in 2016."

INDICATION

Dyanavel XR (amphetamine) extended-release oral suspension is a central nervous system (CNS) stimulant indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

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 during therapy.

About Tris Pharma

Tris Pharma is a specialty pharmaceutical company focused on the research and development of technologies-driven products. Tris has pioneered the delivery of extended release formulations in the liquid, chewable, ODT and strip dosage forms. Tris also makes available a Nobuse™ platform that may provide abuse-deterrence for opioids and other abuse-prone drugs. Dyanavel XR was not approved with the Nobuse platform. The Tris R&D and manufacturing facilities are located in Monmouth Junction, New Jersey, USA.

Source: Tris Pharma, Inc.

Posted: October 2015

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