October 2, 2026 – AUSTIN, Texas – Texas Attorney General Ken Paxton has secured a $7.5 million settlement with New Jersey-based drug manufacturer Tris Pharmaceuticals following allegations that the company lied about the efficacy of its pediatric attention-deficit/hyperactivity disorder (ADHD) medication, Dyanavel XR.
The settlement resolves a lawsuit filed by Paxton’s office in 2023 against Tris Pharma and its CEO, Ketan Mehta. The legal action stemmed from an investigation revealing an alleged scheme to defraud the Texas Medicaid program through false and deceptive marketing claims aimed at healthcare providers.
The active drug in Dyanavel XR is amphetamine, a central nervous system (CNS) stimulant. It works by increasing levels of key neurotransmitters—specifically dopamine and norepinephrine—in the brain, which helps improve focus, attention, and impulse control. As an extended-release formulation, it delivers steady symptom management for Attention Deficit Hyperactivity Disorder (ADHD) throughout the day in patients 6 years of age and older. Because amphetamine carries a high potential for abuse, dependence, and misuse, it is classified as a Schedule II controlled substance.
According to state prosecutors, Tris Pharma systematically inflated the proven performance of Dyanavel XR to boost sales. Sales representatives were instructed to make misleading claims to physicians—including those treating children under Texas Medicaid—falsely asserting that the drug acted significantly faster than competing ADHD treatments and offered other unverified therapeutic benefits for pediatric patients. State records indicate these deceptive pitches were made during thousands of sales visits.
Amphetamine and methamphetamine are closely related “chemical cousins” within the same stimulant drug class, but they differ significantly in potency and effects. Methamphetamine is created by adding a single methyl group to the standard amphetamine molecule. This small structural change allows methamphetamine to cross the blood-brain barrier much faster and deliver far higher concentrations of dopamine to the brain. As a result, methamphetamine is considerably more potent, faster-acting, and carries a drastically higher potential for addiction, severe neurotoxicity, and physical harm compared to prescription amphetamines taken at therapeutic doses for ADHD.
“Tris Pharma is now paying millions of dollars for misleading folks about ADHD drugs being prescribed to children,” Attorney General Paxton said in a statement announcing the agreement. “Pharmaceutical companies that distort the truth to sell their products will face the consequences. I will continue using every tool available to protect Texas children, safeguard taxpayer dollars, and hold Big Pharma accountable.”
A Schedule II controlled substance is a drug that has a high potential for abuse, a currently accepted medical use with severe restrictions, and an abuse risk that may lead to severe psychological or physical dependence.
Common Examples
- Opioids and Narcotics: Fentanyl, oxycodone (OxyContin), hydrocodone (Vicodin), methadone, morphine, and cocaine.
- Stimulants: Amphetamine/dextroamphetamine (Adderall), methylphenidate (Ritalin), and methamphetamine.
- Depressants: Pentobarbital and amobarbital
Under the terms of the settlement, Tris Pharma will pay $7.5 million directly to the state of Texas. The agreement brings an end to the litigation while signaling increased state enforcement against pharmaceutical manufacturers regarding pediatric drug marketing.
