TRV250 / Trevena - LARVOL DELTA

A Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous TRV250 (clinicaltrials.gov) - P1; N=9; Terminated; Sponsor: Trevena Inc.; N=360 ➔ 9; Recruiting ➔ Terminated; Because there have been significant enrollment struggles which has been exacerbated by the COVID impact. This has caused an undue delay to the study timelines and its enrollment goals beyond the business needs.

Enrollment change • Trial termination • CNS Disorders • Migraine

Trevena, Inc. Announces Presentations at the Virtual 2020 American College of Clinical Pharmacology Annual Meeting (GlobeNewswire) - "Live presentation highlighting TRV027 as a potential treatment for COVID-19 acute respiratory distress syndrome (ARDS) / abnormal clotting; Posters on OLINVYK benefit-risk profile and TRV250 Phase 1 pharmacokinetics; Trevena, Inc....today announced three presentations at the virtual 2020 American College of Clinical Pharmacology (ACCP) Annual Meeting, taking place from September 21st to 23rd, 2020. The Company will give a live presentation on TRV027....Company will present two posters highlighting previously published data for OLINVYK, which is approved in the U.S. for the management of acute pain, and TRV250, its delta receptor selective agonist being developed for the acute treatment of migraine."

Clinical data • Live event • P1 data • PK/PD data • CNS Disorders • Infectious Disease • Migraine • Novel Coronavirus Disease • Pain

A Phase I, Randomized, Single‑Blind, Placebo‑Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Oral TRV250, a G Protein-Selective Delta Receptor Agonist, in Healthy Subjects. (PubMed, CNS Drugs) - "The findings from the first-in-human study support further evaluation of TRV250, a G-protein selective DOR agonist, in the treatment of acute migraine."

Clinical • Journal • PK/PD data • Cardiovascular • CNS Disorders • Epilepsy • Hematological Disorders • Migraine • Suicidal Ideation

Biased ligands as a path to safer analgesics (oliceridine, TRV734 and TRV250) (CPDD 2018) - No abstract available.

Biosimilar • CNS Disorders • Pain

Trevena pauses enrollment in proof-of-concept clinical trials for TRV250 And TRV734 (Reuters) - “Trevena…announced that enrollment has been paused in proof-of-concept clinical trials for trv250 and trv734….Trevena - withdrawing previous guidance with respect to timing of top line data for TRV250 and TRV734....Announced the U.S. FDA review of the resubmission of NDA for oliceridine is ongoing; Expects the FDA’S PDUFA goal date for completion of the FDA’s review of the NDA for oliceridine to remain August 7, 2020."

Enrollment status • NDA • PDUFA date

A Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous TRV250 (clinicaltrials.gov) - P1; N=360; Recruiting; Sponsor: Trevena Inc.

Clinical • New P1 trial

Trevena Presents Phase 1 Data on TRV250 for Acute Migraine at American College of Neuropsychopharmacology 2019 Annual Meeting (GlobeNewswire, Trevena Inc.) - "Trevena, Inc....today announced a poster presentation at the 58th Annual Meeting of the American College of Neuropsychopharmacology (ACNP), in Orlando, FL. The poster presentation featured results from a Phase 1 first-in-human study that evaluated the safety, tolerability, and pharmacokinetics (PK) of TRV250, the Company’s novel G protein-selective delta-receptor agonist being developed for the acute treatment of migraine....'The positive data from this Phase 1 study informed our recently initiated proof-of-concept study, with topline data anticipated in the second half of next year.'"

P1 data

Trevena Reports Third Quarter 2019 Results and Topline Data From Multi-Dose Healthy Volunteer QT Study (GlobeNewswire, Trevena Inc.) - "Company expects to resubmit NDA for oliceridine in Q1 2020 . Acute migraine proof-of-concept study for TRV250 initiated...Trevena, Inc...today announced topline results from its multi-dose QT study for IV oliceridine, reported its financial results for the third quarter ended September 30, 2019, and provided an overview of its recent operational highlights....Initiated TRV250 acute migraine proof-of-concept study....The Company anticipates reporting topline data from this study in the second half of 2020."

Clinical data • NDA • Trial status

A Phase 1 Healthy Volunteer Study of the Safety, Tolerability and Pharmacokinetics of TRV250, a G Protein-Selective Delta Receptor Agonist (ACNP 2019) - "In this first-in-human study, TRV250, a G protein-selective DOR agonist, showed safety, tolerability and a pharmacokinetic profile supporting its potential use in the treatment of acute migraine."

Clinical • P1 data • PK/PD data

Trevena reports second quarter 2019 results (GlobeNewswire) - "Advanced acute migraine proof-of-concept study protocol for TRV250. This double-blind, placebo-controlled clinical study will enroll approximately 120 migraineurs in a validated nitroglycerin (NTG) provocation migraine model...The Company continues to expect to initiate this study in the fourth quarter of 2019."

New trial