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

