FDA okays Tris Pharma's liquid non-stimulant drug for paediatric ADHD

2024-05-30

上市批准

Tris Pharma announced that the FDA has cleared Ondya XR (clonidine hydrochloride) for paediatric use in attention-deficit hyperactivity disorder (ADHD).

The once-daily extended-release non-stimulant oral suspension, with night-time dosing, is indicated as monotherapy or adjunctive therapy to stimulants for ADHD patients as young as six years old. According to Tris, Ondya XR is the first liquid non-stimulant ADHD product approved in the US. The drug is slated to hit US pharmacies in the second half.

Non-stimulant formulations are crucial for patients who don't respond well to stimulants or experience adverse effects from them. “Securing FDA approval…is not just an important milestone, but a testament to our unwavering commitment to…improving outcomes for this patient population,” remarked Tris CEO Ketan Mehta.

The company noted that Ondya XR’s approval was backed by data from well-controlled studies of clonidine hydrochloride extended-release tablets.

Clonidine was introduced in clinical practice in 1966 as a centrally acting anti-hypertensive agent, and remains a widely-prescribed drug for multiple indications. The extended-release tablet of clonidine hydrochloride marketed as Kapvay by Shionogi was first approved in 2010 for the treatment of ADHD.

Apart from Ondya XR, Tris’ current portfolio of oral extended-release ADHD medications includes Dynavel XR (amphetamine) and Quillivant XR/QuilliChew ER (methylphenidate hydrochloride), which have been developed using the company’s proprietary LiquiXR technology. Tris’ pipeline also has several candidates in development for ADHD, pain, addiction and other neurological disorders.

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