NSAIDS May Limit Passage of Narcolepsy Medication Gamma Hydroxybutyric Acid to the Brain
Previous studies completed by the UB researchers found that the NSAIDs ibuprofen and ketoprofen also affected the movement of GHB in the body.
Tag: Jazz Pharmaceuticals
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Latest2020 Roundup: The Year in FDA Clearances & Approvals for Sleep Medicine
It’s been an unusual year. But, mostly as usual, the US Food & Drug Administration continued to review device and drug applications across all fields of medicine.
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Taking Back Control in Hypersomnia Disorders
A common concern in narcolepsy and idiopathic hypersomnia is a feeling of having little control over symptoms, which can lead to despair. But disorders of excessive sleepiness do have both medication and non-medication treatment approaches.
7 Myths About Narcolepsy, Debunked
Sleep professionals and the general public have misperceptions about the neurological sleep disorder. How many did you believe?
Read MoreThese Sleep Medicine Products Got FDA Nod in 2019
Sleep Review annually rounds up the sleep medicine devices, pharmaceuticals, and more that earned US Food and Drug Administration clearance.
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FDA Accepts NDA for Low-Sodium Alternative to Xyrem for Narcolepsy
The FDA accepted for filing with Priority Review the Jazz Pharmaceuticals plc’s NDA seeking marketing approval for JZP-258, an investigational medicine for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.
Read MoreSolriamfetol Improves Quality of Life in People With Narcolepsy
Solriamfetol, a dopamine and norepinephrine reuptake inhibitor, offers short-term improvements in health-related quality of life (HRQoL), and work productivity in people with narcolepsy, according to study results published in Sleep Medicine.
Read MoreJazz Submits NDA for Lower-Sodium Narcolepsy Investigational Drug
Jazz Pharmaceuticals plc submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on January 21, 2020, seeking marketing approval for JZP-258, an investigational medicine for the treatment of...
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Survey: Your Narcolepsy Patients Don’t Necessarily Agree That Their Symptoms Are Controlled
Investigators surveyed health care providers as well as people with narcolepsy, and multiple...
Read MoreJazz Pharmaceuticals’ Sunosi Gets EU Marketing Authorization for Excessive Daytime Sleepiness in Narcolepsy or Obstructive Sleep Apnea
The European Commission has approved Jazz Pharmaceuticals plc’s Sunosi (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or...
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European Medicines Agency Committee Recommends Jazz Pharmaceuticals’ Solriamfetol for Marketing Authorization
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)...
Read MoreJazz Pharma’s Sleep Disorder Drug Gets European Panel Backing
Solriamfetol, which will be branded as Sunosi, has been backed for the treatment of excessive sleepiness in adult patients with narcolepsy and obstructive sleep apnea (OSA), according to a statement from the...
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In Phase 3, Low Sodium Alternative to Xyrem Achieves Primary and Secondary Endpoints
Positive data from the Phase 3 study of Jazz Pharmaceuticals plc’s investigational medicine,...
Read MoreDEA Designates Jazz Pharmaceutical’s Sunosi as Having Low Potential for Abuse, Low Risk of Dependence
The U.S. Drug Enforcement Agency (DEA) has designated Jazz Pharmaceuticals plc’s solriamfetol, also known as Sunosi, as a Schedule IV medicine, which is its category for drugs with a low potential for abuse and low risk of...
Read MoreProject Sleep Awards Record 18 Scholarships to Students Pursuing Higher Education
Project Sleep, a national organization that aims to educate individuals about the importance of sleep health, awarded 18 recipients with a 2019 Jack & Julie Narcolepsy Scholarship. This is the largest class of recipients to...
Read MoreJazz Pharmaceuticals Data to Showcase Ongoing Sleep Medicine Research at SLEEP 2019
Fourteen abstracts sponsored by Jazz Pharmaceuticals and one abstract from an investigator-sponsored trial focusing on sodium oxybate will be presented at SLEEP 2019 San Antonio from June 8-12, 2019. “Jazz is committed to...
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When Treating Narcolepsy Isn’t Enough
Health professionals mistaking narcolepsy for psychiatric conditions is real. But so is failing to...
Read MoreWithout Determining Liability, Jazz Pharmaceuticals Agrees to Pay $57 Million to Resolve US Government Allegations that It Paid Kickbacks Through Copay Assistance Foundation
Jazz Pharmaceuticals plc has agreed to pay $57 million to resolve allegations it violated the False Claims Act by illegally paying the Medicare or Civilian Health and Medical Program (ChampVA) copays for its own products,...
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