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PharmaShots CXO Talks | Women’s History Month Special: A Conversation with Dr. Emanuela Offidani of Tris Pharma

Shots: Dr. Emanuela Offidani explains how ADHD is increasingly recognized as a lifelong condition affecting both children and adults. She highlights that symptoms can differ across genders and are often underdiagnosed in women due to less visible hyperactivity and more internalized symptoms such as inattention and emotional dysregulation. The conversation explores how Tris Pharma is…

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Tris Pharma

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…

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Tris Pharma

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…

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Tris Pharma

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…

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