Tris Pharma captures FDA nod for non-stimulant ADHD treatment Onyda XR

29 May 2024
www.fiercepharma.com
Drug Approval
Tris Pharma captures FDA nod for non-stimulant ADHD treatment Onyda XR
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Source: FiercePharma
With a new formulation of an old drug, clonidine, Tris Pharma has gained an FDA nod to treat pediatric patients with ADHD.
Stimulants are typically the go-to option for doctors prescribing treatments for attention-deficit hyperactivity disorder (ADHD). But some ADHD patients do not respond adequately to stimulants or have difficulty with their side effects.
Providing a new alternative is Tris Pharma, which has won FDA approval for Onyda XR (clonidine hydrochloride). The extended-release oral suspension becomes the first liquid non-stimulant medication for ADHD and the only non-stimulant with nighttime dosing in the indication.
Onyda XR can be used as a monotherapy or in combination with central nervous system stimulants in pediatric patients ages 6 and older. Tris expects Onyda XR to be available in the second half of this year.
Through a company spkesperson, CEO and founder Ketan Mehta said that Tris anticipates "having pricing details available" as the launch approaches.
Onyda XR adds to the portfolio of ADHD medications offered by the 24-year-old, privately-owned New Jersey drugmaker which develops and manufactures specialty generics along with branded and over-the-counter products.
Tris sells ADHD medications in liquid and tablet form for both adults and children. All were developed with the company’s LiquiXR drug delivery technology, which allows immediate-release products to be transformed into those with extended-release characteristics, providing for once-daily dosing.
The platform facilitated the development of Onyda XR from an older compound. The FDA signed off on clonidine pills to treat high blood pressure 50 years ago. In addition, Viatris markets Duraclon, an injected formulation of clonidine used in combination with opiates for severe pain in cancer patients.
In light of the United States' opioid epidemic, Tris has drawn attention for its effort to develop cebranopadol, an opioid that is not as addictive.
Last year, Tris and Pfizer were accused by the state of Texas of knowingly providing a compromised ADHD medicine, Quillivant XR, to a state Medicaid program for children of low-income families. Tris had helped develop the drug and served as a manufacturing partner.
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