Tris Pharma receives FDA approval for non-stimulant ADHD treatment Onyda XR

Tris Pharma has secured FDA approval for a new formulation of clonidine to treat pediatric ADHD patients. Traditionally, stimulant medications are the primary choice for ADHD treatment. However, some patients experience inadequate responses or troublesome side effects from stimulants.

Tris Pharma introduces Onyda XR (clonidine hydrochloride), an extended-release oral suspension. This new medicine is the first liquid, non-stimulant option for ADHD and uniquely offers nighttime dosing. Onyda XR is suitable for monotherapy or can be combined with central nervous system stimulants for children aged six and older. The company plans to release Onyda XR in the latter half of the year. CEO and founder Ketan Mehta mentioned through a spokesperson that pricing details would be disclosed closer to the launch.

Onyda XR is an addition to Tris Pharma's ADHD medication lineup. The 24-year-old, privately-owned New Jersey-based company specializes in developing and manufacturing specialty generics, branded medications, and over-the-counter products. Tris Pharma’s ADHD medications come in both liquid and tablet forms for children and adults. All of these products utilize the company’s LiquiXR drug delivery technology, which converts immediate-release drugs into extended-release formulations for once-daily dosing.

The FDA originally approved clonidine pills to manage high blood pressure 50 years ago, and Viatris currently markets Duraclon, an injectable clonidine used with opioids for severe cancer pain. Tris Pharma’s proprietary technology facilitated the development of Onyda XR from the older clonidine compound.

In addition to its efforts in ADHD treatment, Tris Pharma has been noted for developing cebranopadol, an opioid with a lesser tendency for addiction, responding to the ongoing opioid crisis in the United States.

However, Tris Pharma faced legal challenges last year. Alongside Pfizer, the company was accused by the state of Texas of knowingly supplying a compromised ADHD medication, Quillivant XR, to a state Medicaid program that serves low-income children. Tris Pharma played a significant role in the development of Quillivant XR and acted as its manufacturing partner.