APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the µ-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy

Autor: Viscusi ER, Skobieranda F, Soergel DG, Cook E, Burt DA, Singla N

Publikováno v: Journal of Pain Research, Vol Volume 12, Pp 927-943 (2019)

Eugene R Viscusi,1 Franck Skobieranda,2 David G Soergel,2 Emily Cook,2 David A Burt,2 Neil Singla3 1Department of Anesthesiology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, USA; 2Trevena Inc., Chesterbrook, PA, US

Externí odkaz: https://doaj.org/article/577a02507a4b4e65b30009f7438b96ba

Two-Part Phase 1 Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of TRV734 in Healthy Adults.

Autor: Ramos KA; Trevena, Inc., Chesterbrook, Pennsylvania, USA., James IE; Trevena, Inc., Chesterbrook, Pennsylvania, USA., Skobieranda F; Trevena, Inc., Chesterbrook, Pennsylvania, USA., Soergel DG; Trevena, Inc., Chesterbrook, Pennsylvania, USA., Ruff D; ICON Early Phase Services, San Antonio, Texas, USA., Fossler MJ; Trevena, Inc., Chesterbrook, Pennsylvania, USA.

Publikováno v: Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2022 Jan; Vol. 11 (1), pp. 51-62. Date of Electronic Publication: 2021 Sep 03.

Once-nightly sodium oxybate (FT218) in the treatment of narcolepsy: a letter to the editor commenting on the recent publication by C. Kushida et al.

Autor: Skobieranda F; Clinical Development, Neuroscience, Jazz Pharmaceuticals, Philadelphia, PA, USA., Candler S; US Medical Affairs, Neuroscience, Jazz Pharmaceuticals, Philadelphia, PA, USA., Macfadden W; Global Medical Affairs, Neuroscience, Jazz Pharmaceuticals, Philadelphia, PA, USA.

Publikováno v: Sleep [Sleep] 2022 Jun 13; Vol. 45 (6).

Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study.

Autor: Dauvilliers Y; Sleep and Wake Disorders Centre, Department of Neurology, Gui de Chauliac Hospital, Montpellier, France; University of Montpellier, INSERM Institute Neuroscience Montpellier, Montpellier, France. Electronic address: ydauvilliers@yahoo.fr., Arnulf I; Sleep Disorder Unit, Pitié-Salpêtrière Hospital and Sorbonne University, Paris, France., Foldvary-Schaefer N; Cleveland Clinic Lerner College of Medicine, Cleveland, OH, USA., Morse AM; Janet Weis Children's Hospital, Geisinger, Danville, PA, USA., Šonka K; Department of Neurology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic., Thorpy MJ; Albert Einstein College of Medicine, Bronx, NY, USA., Mignot E; Stanford University Center for Narcolepsy, Redwood City, CA, USA., Chandler P; Jazz Pharmaceuticals, Palo Alto, CA, USA., Parvataneni R; Jazz Pharmaceuticals, Palo Alto, CA, USA., Black J; Jazz Pharmaceuticals, Palo Alto, CA, USA; Stanford Center for Sleep Sciences and Medicine, Palo Alto, CA, USA., Sterkel A; Jazz Pharmaceuticals, Palo Alto, CA, USA., Chen D; Jazz Pharmaceuticals, Palo Alto, CA, USA., Skobieranda F; Jazz Pharmaceuticals, Philadelphia, PA, USA., Bogan RK; University of South Carolina School of Medicine, Columbia, SC, USA.

Publikováno v: The Lancet. Neurology [Lancet Neurol] 2022 Jan; Vol. 21 (1), pp. 53-65.

Efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate [LXB]; JZP-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy.

Autor: Bogan RK; School of Medicine, University of South Carolina, Columbia, SC., Thorpy MJ; Department of Neurology, Albert Einstein College of Medicine, Bronx, NY., Dauvilliers Y; Sleep and Wake Disorders Centre, Department of Neurology, Gui de Chauliac Hospital, Montpellier, France.; Department of Neurology, University of Montpellier, INSERM U1061, Montpellier, France., Partinen M; Helsinki Sleep Clinic, Vitalmed Research Center, Helsinki, Finland., Del Rio Villegas R; Neurophysiology and Sleep Disorders Unit, Hospital Vithas Nuestra Señora de America, Madrid, Spain., Foldvary-Schaefer N; Sleep Disorders Center, Cleveland Clinic, Cleveland, OH., Skowronski R; Global Clinical Development, Jazz Pharmaceuticals, Inc., Palo Alto, CA., Tang L; Biostatistics, Jazz Pharmaceuticals, Inc., Palo Alto, CA., Skobieranda F; Global Clinical Development, Jazz Pharmaceuticals, Inc., Palo Alto, CA., Šonka K; Department of Neurology, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.

Publikováno v: Sleep [Sleep] 2021 Mar 12; Vol. 44 (3).