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

2024-05-29

上市批准

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 opticlonidinectTris Pharmabing treatmentsFDAr attention-deficit hyperactivity disoADHD (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 attention-deficit hyperactivity disorder (ADHD)ase oral suADHDsion 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 monotTris Pharman combination wiFDAcentral nervous system stimulants in pediatric patients ages 6 and older. Tris expects Onyda XR to be available in the second half of this yeADHD

Onyda XRa company spkesperson, CEO and founder Ketan Mehta sacentral nervous system stimulantspricing details available" as the launch Trisoaches.Onyda XR

Onyda XR adds to the portfolio of ADHD medications offered by the 24-Tris-old, privately-owned New Jersey drugmaker which develops and manufactures specialty generics along with branded and over-the-counter products.

Onyda XRls ADHD medications in liqADHDand 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.

TrisplatforADHDcilitated 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 epidemOnyda XR has drawn attention for its FDAort to develop cebranopadol, an opioid that is not as addictive.Viatris Duraclon clonidine pain cancer

Last year, Tris and Pfizer were accused by the sTris of Texas of knowingly providing a compromised cebranopadole, Quopioidnt 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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