gamma-Hydroxybutyric acid

Avadel Pharmaceuticals to Present at the Ladenburg Thalmann Annual Healthcare Conference 2021

Retrieved on: 
Wednesday, July 7, 2021
Psychoactive drugs, Sleep disorders, Branches of biology, Neurochemistry, Narcolepsy, Sodium oxybate, Cataplexy, gamma-Hydroxybutyric acid, Excessive daytime sleepiness, Food and Drug Administration, Idiopathic hypersomnia

ET.

Key Points: 
  • ET.
  • A live webcast of this event, as well as an archived recording, will be available on Avadels Investor Relations website, www.investors.avadel.com , for 90 days following the conference.
  • Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly, extended-release formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.
  • For more information, please visit www.avadel.com .

Jazz Pharmaceuticals Announces Orphan Drug Exclusivity for Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution

Retrieved on: 
Friday, June 25, 2021
Chemistry, Physical sciences, Natural sciences, Dietary minerals, Alkali metals, Chemical elements, Desiccants, Reducing agents, Sodium oxybate, Potassium, Sodium, gamma-Hydroxybutyric acid

According to FDA, "Xywav (calcium, magnesium, potassium, and sodium oxybates) is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem."

Key Points: 
  • According to FDA, "Xywav (calcium, magnesium, potassium, and sodium oxybates) is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem."
  • "We are pleased that FDA has recognized the greater safety of Xywav by virtue of the greatly reduced chronic sodium burden.
  • The seven-year market exclusivity for Xywav began on July 21, 2020, the date of FDA approval.
  • Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution Prescribing Information.Palo Alto, CA:Jazz Pharmaceuticals, Inc.
    Black J,Reaven NL, Funk SE, et al.

Jazz Pharmaceuticals Announces Orphan Drug Exclusivity for Xywav™ (calcium, magnesium, potassium, and sodium oxybates) Oral Solution

Retrieved on: 
Friday, June 25, 2021
Chemistry, Physical sciences, Natural sciences, Dietary minerals, Alkali metals, Chemical elements, Desiccants, Reducing agents, Sodium oxybate, Potassium, Sodium, gamma-Hydroxybutyric acid

According to FDA, "Xywav (calcium, magnesium, potassium, and sodium oxybates) is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem."

Key Points: 
  • According to FDA, "Xywav (calcium, magnesium, potassium, and sodium oxybates) is clinically superior to Xyrem by means of greater safety because Xywav provides a greatly reduced chronic sodium burden compared to Xyrem."
  • "We are pleased that FDA has recognized the greater safety of Xywav by virtue of the greatly reduced chronic sodium burden.
  • The seven-year market exclusivity for Xywav began on July 21, 2020, the date of FDA approval.
  • Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution Prescribing Information.Palo Alto, CA:Jazz Pharmaceuticals, Inc.
    Black J,Reaven NL, Funk SE, et al.

XWPharma Announces Positive Results from Phase 1 Clinical Trials of XW10172, in Development as Once-Nightly Therapy for Sleep Disorders in Patients with Neurodegenerative Diseases

Retrieved on: 
Monday, June 14, 2021
Branches of biology, Psychoactive drugs, Sleep disorders, Neuroscience, Narcolepsy, Sodium oxybate, Excessive daytime sleepiness, Somnolence, gamma-Hydroxybutyric acid, Sleep, Microsleep, Idiopathic hypersomnia

For patients with a variety of sleep disorders, these results establish desired drug properties, including a favorable safety profile and optimal pharmacokinetics suitable for once-nightly dosing of XW10172, said Dr. Canafax.

Key Points: 
  • For patients with a variety of sleep disorders, these results establish desired drug properties, including a favorable safety profile and optimal pharmacokinetics suitable for once-nightly dosing of XW10172, said Dr. Canafax.
  • Based on these data, we believe the drug offers potential as treatment in sleep disorders in patients with Parkinsons disease and patients with other neurodegenerative diseases, for which no drugs are currently indicated despite the high unmet medical need.
  • Additionally, once-nightly dosing and the absence of sodium are features that support XW10172 as potential best-in-class treatment for patients with narcolepsy.
  • Two investigator-initiated trials have reported sodium oxybate to be effective in treating excessive daytime sleepiness in patients with Parkinsons disease and improved sleep architecture.

 Jazz Pharmaceuticals Presents 18 Abstracts in Sleep Medicine at SLEEP 2021

Retrieved on: 
Wednesday, June 9, 2021
Psychoactive drugs, Drugs, Euphoriants, Stimulants, Orphan drugs, Sedatives, Phenethylamines, Solriamfetol, gamma-Hydroxybutyric acid, Heroin, Medication

Abuse or misuse of illegal GHB alone or with other drugs that cause changes in alertness (or consciousness) has caused serious side effects.

Key Points: 
  • Abuse or misuse of illegal GHB alone or with other drugs that cause changes in alertness (or consciousness) has caused serious side effects.
  • Call your doctor right away if you or your child has any of these serious side effects.
  • In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma LLC.
  • Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia.

Avadel Pharmaceuticals to Present at the Jefferies Virtual Healthcare Conference

Retrieved on: 
Tuesday, May 25, 2021
Psychoactive drugs, Sleep disorders, Branches of biology, Neurochemistry, Narcolepsy, Sodium oxybate, Cataplexy, gamma-Hydroxybutyric acid, Excessive daytime sleepiness, Food and Drug Administration, Pitolisant, Idiopathic hypersomnia

ET.

Key Points: 
  • ET.
  • A live webcast of this event, as well as an archived recording, will be available on Avadels Investor Relations website, www.investors.avadel.com , for 90 days following the conference.
  • Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly, extended-release formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy.
  • For more information, please visit www.avadel.com .

XWPharma Announces Abstract for XW10172 Accepted for Presentation at the Associated Professional Sleep Societies SLEEP 2021 Annual Meeting

Retrieved on: 
Wednesday, May 19, 2021
Branches of biology, Sleep disorders, Glutamate, Neurochemistry, Psychoactive drugs, General anesthetics, Neurotransmitters, Amphetamine, Narcolepsy, gamma-Hydroxybutyric acid, Excessive daytime sleepiness, AMPA

The drug and formulation are designed to deliver oxybate without the sodium content of other products that is associated with increased cardiovascular health risk and monitoring requirements.

Key Points: 
  • The drug and formulation are designed to deliver oxybate without the sodium content of other products that is associated with increased cardiovascular health risk and monitoring requirements.
  • XWPharma's expertise in drug design is focused on providing potential first- and best-in-class medicines with differentiated features to address the unmet medical needs of patients suffering from debilitating neurological diseases.
  • XW10172 is a clinical-stage conjugate of the GABAB agonist, oxybate, in development as an investigational once-nightly therapy intended to regulate the patient\xe2\x80\x99s sleep cycle in order to alleviate excessive daytime sleepiness and other consequences of sleep dysfunction associated with neurodegenerative diseases, including Parkinson\xe2\x80\x99s disease and narcolepsy.
  • XW10508 is a glutamatergic NMDA antagonist and AMPA activator in development as an oral, once-daily therapy with potential abuse deterrent properties, designed for the treatment of major depressive disorder and chronic pain.\n"

Avadel to Present New Data from its Pivotal REST-ON Phase 3 Study of FT218 at the American Academy of Neurology Annual Meeting 2021

Retrieved on: 
Thursday, April 8, 2021
Psychoactive drugs, Branches of biology, Neurochemistry, Food and Drug Administration, Pharmaceuticals policy, gamma-Hydroxybutyric acid, Narcolepsy, Sodium oxybate, Prescription Drug User Fee Act, Micropump

FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadels MicroPump controlled-release (CR) technology.

Key Points: 
  • FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadels MicroPump controlled-release (CR) technology.
  • The NDA for FT218 was accepted by the FDA in February 2021 and assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2021.
  • FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy.
  • In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

Avadel Pharmaceuticals to Participate in a Fireside Chat at Stifel’s Third Annual CNS Day on March 31st

Retrieved on: 
Thursday, March 18, 2021
Sleep disorders, Branches of biology, Psychoactive drugs, Neurochemistry, Narcolepsy, Sodium oxybate, Cataplexy, Excessive daytime sleepiness, gamma-Hydroxybutyric acid, Somnolence

DUBLIN, Ireland, March 18, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, announced today that members of the Avadel management team will participate in a fireside chat at Stifel's Third Annual CNS Day, which is being held on March 31st.

Key Points: 
  • DUBLIN, Ireland, March 18, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, announced today that members of the Avadel management team will participate in a fireside chat at Stifel's Third Annual CNS Day, which is being held on March 31st.
  • Avadels fireside chat is scheduled for 3 p.m.
  • ET on Wednesday, March 31st.
  • A live webcast of this event, as well as an archived recording, will be available at ( click here ), as well as on Avadels website, www.avadel.com , for 90 days from being made available.

Avadel Pharmaceuticals Announces Publication of Once-Nightly FT218 Pharmacokinetic Studies

Retrieved on: 
Tuesday, March 2, 2021
Psychoactive drugs, Branches of biology, Sleep disorders, Neurochemistry, Sodium oxybate, Narcolepsy, gamma-Hydroxybutyric acid, Cataplexy, Bioequivalence, Excessive daytime sleepiness, Pharmacokinetics

DUBLIN, Ireland, March 02, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc(Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the online publication in Clinical Therapeutics of four Phase 1 studies from the FT218 pharmacokinetic program.

Key Points: 
  • DUBLIN, Ireland, March 02, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc(Nasdaq: AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the online publication in Clinical Therapeutics of four Phase 1 studies from the FT218 pharmacokinetic program.
  • Once-nightly FT218 utilizes Avadels proprietary, controlled-release technology platform to optimize the pharmacokinetic profile of sodium oxybate by providing a blend of immediate-release and controlled-release microparticles.
  • Such forward-looking statements include, but are not limited to, the pharmacokinetic profile of FT218, the bioequivalence of FT218 to twice-nightly sodium oxybate, and the potential benefits of FT218, if approved.
  • The pharmacokinetics of once-nightly controlled- release sodium oxybate (FT218): overview of results from four phase 1 studies.