Avadel Pharmaceuticals

Avadel Pharmaceuticals reports $50 million in LUMRYZ revenue, 2,300 patients on the drug, and FDA approval for pediatric use. The company also secured a court ruling affirming LUMRYZ's clinical superiority over twice-nightly oxybates and is progressing its Phase 3 REVITALYZ study.

US court upholds FDA approval of Avadel Pharmaceuticals' Lumryz, a once-nightly oxybate for narcolepsy, rejecting Jazz Pharmaceuticals' challenge on orphan status and clinical superiority grounds. Lumryz retains orphan drug exclusivity and is deemed clinically superior to existing treatments.

Avadel Pharmaceuticals' LUMRYZ received a favorable court ruling affirming FDA approval, despite Jazz Pharmaceuticals' challenge under the Orphan Drug Act. LUMRYZ, the only once-at-bedtime oxybate treatment for narcolepsy, was also approved for pediatric use and demonstrated efficacy in clinical trials. Avadel anticipates operating income in Q3 2024, with analysts projecting over $600 million in sales by 2030. A study found 94% of participants preferred LUMRYZ over twice-nightly treatments.

Avadel Pharmaceuticals announced the U.S. District Court upheld the FDA's approval of LUMRYZ, a once-at-bedtime oxybate treatment for narcolepsy, against Jazz Pharmaceuticals' lawsuit. LUMRYZ retains its Orphan Drug Exclusivity.

The Mind Moments® podcast features Anne Marie Morse, DO, FAASM, discussing the FDA's approval of sodium oxybate for pediatric narcolepsy, emphasizing clinical considerations and cautious use.

SPN-820, an intracellular modulator of mTORC1, showed safety and efficacy in a phase IIa study for major depressive disorder. A Danish study found a 4.5-fold higher risk of sudden cardiac death in schizophrenic patients. The FDA expanded approval of sodium oxybate (Lumryz) for narcolepsy in children aged 7 and up. A cohort study identified eight forms of traumatic and adverse childhood experiences that affect psychiatric risk and cognitive ability differently. Mental illness may increase COVID-19 severity. GIP and/or GLP-1 receptor agonists reduced opioid overdose and alcohol intoxication rates in adults with opioid or alcohol use disorder. Lykos Therapeutics plans an additional phase III trial for MDMA-assisted PTSD therapy after FDA rejection. A psychiatrist recommends dementia tests for Donald Trump. Maternal prenatal cannabis use was not linked to child autism spectrum disorder. Over 2,400 Kaiser Permanente mental health workers went on strike in Southern California. Home-based transcranial direct current stimulation improved depression scores in a phase II trial. A Lancet Psychiatry Commission aims to limit harms of problematic internet usage. The FCC voted to route 988 Suicide and Crisis Lifeline calls by geolocation.

FDA approved Lumryz for treating cataplexy or excessive daytime sleepiness in narcolepsy patients aged ≥7, expanding from adults only. Clinical trials showed significant improvements in wakefulness, condition, and reduced cataplexy episodes, regardless of alerting agents use. Lumryz offers a single bedtime dose, with Orphan Drug Exclusivity until 2031, but carries a Boxed Warning for CNS depression and misuse risks.

FDA approves sodium oxybate for pediatric narcolepsy; GLP-1 receptor agonists linked to reduced suicidal ideation in obese adolescents; Matthew Davis discusses pediatric health themes; TMS improves depressive symptoms and anxiety in adolescents; Melissa Fickey explains TMS therapy for MDD.

FDA approves Lumryz, a once-daily extended-release therapeutic, for cataplexy or excessive daytime sleepiness in narcolepsy patients aged 7 years and older, based on the REST-ON study results.