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

The first, extended-release amphetamine-based oral liquid for the treatment of ADHD

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.

 

  • Dyanavel XR is contraindicated
    • In patients known to be hypersensitive to amphetamine, or other components of Dyanavel XR. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported
    • During treatment with monoamine oxidase inhibitors (MAOIs) and within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis
  • Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in children and adolescents with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Dyanavel XR.
  • CNS stimulants can cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
  • CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Prior to treatment, assess for the presence of bipolar disorder.
  • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD. Monitor weight and height in children during treatment with Dyanavel XR. Treatment may need to be interrupted in children not growing as expected.
  • CNS stimulants, including Dyanavel XR, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
  • Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, tachycardia. There is limited experience with Dyanavel XR in controlled trials. Based on this limited experience, the adverse reaction profile of Dyanavel XR appears similar to other amphetamine extended-release products. The most common (≥2% 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 6–12 years) were: epistaxis (4%), allergic rhinitis (4%) and upper abdominal pain (4%).
  • Dyanavel XR used during pregnancy may cause fetal harm.
  • Breastfeeding is not recommended during treatment with Dyanavel XR.

Please click here for Full Prescribing Information and Medication Guide, including Boxed WARNING regarding Potential for Abuse and Dependence.

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.

For more information, please visit www.trispharma.com