Tris Pharma Reports P-III Clinical Data of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Shots:Tris has reported topline data from P-III (ALLEVIATE-2) trial in post-bunionectomy pts, plus additional data from P-III (ALLEVIATE-1) trial in post-abdominoplasty pts. Data from both trials, plus HAP studies will support the US FDA’s NDA filing in 2025 ALLEVIATE-2 evaluated cebranopadol (400µg QD, PO) vs oxycodone (10mg QID, PO) vs PBO, meeting its…

ByRidhi RastogiMarch 7, 2025

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Tris Pharma Reports the P-III (ALLEVIATE-1) Study Results of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Shots:The P-III (ALLEVIATE-1) study assessed analgesic efficacy of cebranopadol (400µg, QD) vs PBO for treating moderate-to-severe acute pain post abdominoplasty surgery Study depicted significantly reduced pain intensity as evaluated by Pain Numeric Rating Scale (NRS) AUC4-48 (1.34 mean hourly difference) and a well-tolerated safety with nausea being the common AE Tris will…

ByRidhi RastogiJanuary 23, 2025

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Tris Pharma’s Onyda XR Gains the US FDA’s Approval for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Shots: The US FDA has granted approval to the company’s QD extended-release oral suspension of Onyda XR (clonidine hydrochloride) with nighttime dosing alone or as adj. to approved central nervous system (CNS) stimulant therapies for ADHD treatment in children (≥6yrs.). Its availability is anticipated in H2’24 The approval was supported by the data from studies…

ByDipanshu DixitMay 29, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in November 2021

The US FDA has approved 6 NDAs and 1 BLAs in 2021, leading to treatments for patients and advances in the health care industryThe Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 68 novel products in 2021Additionally, last year in 2020, the US FDA…

BySenior EditorDecember 16, 2021

Tris Pharma Reports P-III Clinical Data of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Tris Pharma Reports the P-III (ALLEVIATE-1) Study Results of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Tris Pharma’s Onyda XR Gains the US FDA’s Approval for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Insights+: The US FDA New Drug Approvals in November 2021

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Tris Pharma Reports P-III Clinical Data of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Tris Pharma Reports the P-III (ALLEVIATE-1) Study Results of Cebranopadol to Treat Moderate-to-Severe Acute Pain

Tris Pharma’s Onyda XR Gains the US FDA’s Approval for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Insights+: The US FDA New Drug Approvals in November 2021

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