Journal: CNS Drugs

Article Title: Therapeutic Use of γ-Hydroxybutyrate: History and Clinical Utility of Oxybates and Considerations of Once- and Twice-Nightly Dosing in Narcolepsy

doi: 10.1007/s40263-024-01150-8

Figure Lengend Snippet: Mean plasma concentrations of orally administered SXB formulations in healthy volunteers. Mean plasma concentrations of 6-g ON-SXB and twice-nightly SXB formulations over a 14-h period in 25 healthy adult volunteers (adapted from Bogan R, et al. Sleep Medicine. 2022;100:442–447 ). *Published GHB plasma levels associated with lack of arousability are illustrated (Busardò FP, Jones AW. Curr Neuropharmacol . 2015;13(1):47–70 ). The estimated plasma concentration of GHB at which there is a risk of death due to respiratory depression is approximately > 500 mg/L (Busardò FP, Jones AW. Curr Neuropharmacol . 2015;13(1):47–70 ). In a study of 16 healthy adult volunteers who were assessed 20–300 min following intravenous administration of GHB, the mean plasma concentration associated with deep sleep/no response to stimuli was approximately 311 mg/L (Helrich M, et al. Anesthesiology. 1964;25:771–775 ). GHB γ-hydroxybutyrate, ON-SXB once-nightly sodium oxybate, SXB sodium oxybate

Article Snippet: Additional sponsors have described efforts to develop extended-release oxybate formulations for once-nightly dosing (XW10172, XW Pharma; Tris Pharma; JZP324, Jazz Pharmaceuticals) [ – ].

Techniques: Clinical Proteomics, Concentration Assay

Journal: CNS Drugs

Article Title: Therapeutic Use of γ-Hydroxybutyrate: History and Clinical Utility of Oxybates and Considerations of Once- and Twice-Nightly Dosing in Narcolepsy

doi: 10.1007/s40263-024-01150-8

Figure Lengend Snippet: Illustrative hypnogram: sleep architecture of a 24-year-old female patient with NT1 before and after treatment with ON-SXB. Illustrative hypnogram of sleep cycles assessed using overnight polysomnography performed in clinic (Kushida CA, et al. Sleep . 2022;45(6):zsab200 ) of an individual with NT1 before and after 13-week treatment with ON-SXB. 1, N1 sleep stage; 2, N2 sleep stage; 3, N3 sleep stage; 4, N4 sleep stage, NT1 narcolepsy type 1, ON-SXB once-nightly sodium oxybate, R rapid eye movement sleep stage, W wake sleep

Article Snippet: Additional sponsors have described efforts to develop extended-release oxybate formulations for once-nightly dosing (XW10172, XW Pharma; Tris Pharma; JZP324, Jazz Pharmaceuticals) [ – ].

Techniques:

Journal: CNS Drugs

Article Title: Therapeutic Use of γ-Hydroxybutyrate: History and Clinical Utility of Oxybates and Considerations of Once- and Twice-Nightly Dosing in Narcolepsy

doi: 10.1007/s40263-024-01150-8

Figure Lengend Snippet: Effects of ON-SXB treatment on sleep architecture parameters with and without concomitant alerting agent use. Change from baseline in ( A ) sleep stage shifts, ( B ) nocturnal arousals, ( C ) VAS sleep quality, and ( D ) VAS refreshing nature of sleep, for participants with or without concomitant alerting agent use (mITT population; Roth T, et al. CNS Drugs . 2022;36(4):377–387 ). * P < 0.05, ** P ≤ 0.01, *** P ≤ 0.001. VAS was on a scale of 1–100. LSM least squares mean, mITT modified intent to treat, ON-SXB once-nightly sodium oxybate, PSG polysomnography, VAS visual analog scale

Article Snippet: Additional sponsors have described efforts to develop extended-release oxybate formulations for once-nightly dosing (XW10172, XW Pharma; Tris Pharma; JZP324, Jazz Pharmaceuticals) [ – ].

Techniques: Modification

Journal: CNS Drugs

Article Title: Therapeutic Use of γ-Hydroxybutyrate: History and Clinical Utility of Oxybates and Considerations of Once- and Twice-Nightly Dosing in Narcolepsy

doi: 10.1007/s40263-024-01150-8

Figure Lengend Snippet: Mean plasma concentrations of orally administered SXB formulations in healthy volunteers. Mean plasma concentrations of 6-g ON-SXB and twice-nightly SXB formulations over a 14-h period in 25 healthy adult volunteers (adapted from Bogan R, et al. Sleep Medicine. 2022;100:442–447 ). *Published GHB plasma levels associated with lack of arousability are illustrated (Busardò FP, Jones AW. Curr Neuropharmacol . 2015;13(1):47–70 ). The estimated plasma concentration of GHB at which there is a risk of death due to respiratory depression is approximately > 500 mg/L (Busardò FP, Jones AW. Curr Neuropharmacol . 2015;13(1):47–70 ). In a study of 16 healthy adult volunteers who were assessed 20–300 min following intravenous administration of GHB, the mean plasma concentration associated with deep sleep/no response to stimuli was approximately 311 mg/L (Helrich M, et al. Anesthesiology. 1964;25:771–775 ). GHB γ-hydroxybutyrate, ON-SXB once-nightly sodium oxybate, SXB sodium oxybate

Article Snippet: Additional sponsors have described efforts to develop extended-release oxybate formulations for once-nightly dosing (XW10172, XW Pharma; Tris Pharma; JZP324, Jazz Pharmaceuticals) [ – ].

Techniques: Clinical Proteomics, Concentration Assay

Journal: CNS Drugs

Article Title: Therapeutic Use of γ-Hydroxybutyrate: History and Clinical Utility of Oxybates and Considerations of Once- and Twice-Nightly Dosing in Narcolepsy

doi: 10.1007/s40263-024-01150-8

Figure Lengend Snippet: Illustrative hypnogram: sleep architecture of a 24-year-old female patient with NT1 before and after treatment with ON-SXB. Illustrative hypnogram of sleep cycles assessed using overnight polysomnography performed in clinic (Kushida CA, et al. Sleep . 2022;45(6):zsab200 ) of an individual with NT1 before and after 13-week treatment with ON-SXB. 1, N1 sleep stage; 2, N2 sleep stage; 3, N3 sleep stage; 4, N4 sleep stage, NT1 narcolepsy type 1, ON-SXB once-nightly sodium oxybate, R rapid eye movement sleep stage, W wake sleep

Article Snippet: Additional sponsors have described efforts to develop extended-release oxybate formulations for once-nightly dosing (XW10172, XW Pharma; Tris Pharma; JZP324, Jazz Pharmaceuticals) [ – ].

Techniques:

Journal: CNS Drugs

Article Title: Therapeutic Use of γ-Hydroxybutyrate: History and Clinical Utility of Oxybates and Considerations of Once- and Twice-Nightly Dosing in Narcolepsy

doi: 10.1007/s40263-024-01150-8

Figure Lengend Snippet: Effects of ON-SXB treatment on sleep architecture parameters with and without concomitant alerting agent use. Change from baseline in ( A ) sleep stage shifts, ( B ) nocturnal arousals, ( C ) VAS sleep quality, and ( D ) VAS refreshing nature of sleep, for participants with or without concomitant alerting agent use (mITT population; Roth T, et al. CNS Drugs . 2022;36(4):377–387 ). * P < 0.05, ** P ≤ 0.01, *** P ≤ 0.001. VAS was on a scale of 1–100. LSM least squares mean, mITT modified intent to treat, ON-SXB once-nightly sodium oxybate, PSG polysomnography, VAS visual analog scale

Article Snippet: Additional sponsors have described efforts to develop extended-release oxybate formulations for once-nightly dosing (XW10172, XW Pharma; Tris Pharma; JZP324, Jazz Pharmaceuticals) [ – ].

Techniques: Modification

Journal: Frontiers in Veterinary Science

Article Title: A review of moxidectin vs. other macrocyclic lactones for prevention of heartworm disease in dogs with an appraisal of two commercial formulations

doi: 10.3389/fvets.2024.1377718

Figure Lengend Snippet: Efficacy of moxidectin and other commonly used macrocyclic lactones against resistant strains of Dirofilaria immitis in laboratory studies: effects on geometric mean worm counts.

Article Snippet: An extended-release microsphere suspension formulation of moxidectin (PH6) was launched in June 2001 in the United States by the former manufacturer Fort Dodge Animal Health, having demonstrated the safety of PH6 as requested by the US Food and Drug Administration Center for Veterinary Medicine (FDA CVM) ( ).

Techniques: Negative Control

Journal: Frontiers in Veterinary Science

Article Title: A review of moxidectin vs. other macrocyclic lactones for prevention of heartworm disease in dogs with an appraisal of two commercial formulations

doi: 10.3389/fvets.2024.1377718

Figure Lengend Snippet: Efficacy of moxidectin and other commonly used macrocyclic lactones against resistant strains of Dirofilaria immitis in laboratory studies: effects on antigen test and micofilariae.

Article Snippet: An extended-release microsphere suspension formulation of moxidectin (PH6) was launched in June 2001 in the United States by the former manufacturer Fort Dodge Animal Health, having demonstrated the safety of PH6 as requested by the US Food and Drug Administration Center for Veterinary Medicine (FDA CVM) ( ).

Techniques: Negative Control

Journal: Frontiers in Veterinary Science

Article Title: A review of moxidectin vs. other macrocyclic lactones for prevention of heartworm disease in dogs with an appraisal of two commercial formulations

doi: 10.3389/fvets.2024.1377718

Figure Lengend Snippet: Effect of moxidectin compared to other commonly used macrocyclic lactones on Dirofilaria immitis antigen test and micofilariae in field studies.

Article Snippet: An extended-release microsphere suspension formulation of moxidectin (PH6) was launched in June 2001 in the United States by the former manufacturer Fort Dodge Animal Health, having demonstrated the safety of PH6 as requested by the US Food and Drug Administration Center for Veterinary Medicine (FDA CVM) ( ).

Techniques: