Narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH) are central nervous system (CNS) disorders of hypersomnolence seen in 0.05-0.1% of the population. Pharmacotherapy is the cornerstone of treatment, aimed at symptom management. Current approved pharmacotherapies for excessive sleepiness (ES) include traditional stimulants, wake promoting agents (modafinil and armodafinil), and sodium oxybate. Sodium oxybate is the only FDA approved agent for cataplexy in NT1. Despite available treatments, ES is insufficiently improved in most patients. In addition, pharmacotherapy is often associated with adverse effects, including depression and cardiovascular system activation. Our research focus is to expand pharmacotherapy clinical trials for patients with CNS hypersomnia and study the effectiveness of pharmacotherapy for NT1, NT2, and IH on sleep-related patient reported outcomes leveraging our large, diverse clinical and laboratory operations.
Nancy Foldvary-Schaefer, DO, MS
2019 - A Phase 2, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 mg and 4 mg SUVN-G3031 Compared to Placebo in Patients with Narcolepsy with and without Cataplexy, Suven Pharmaceuticals, Site PI: N. Foldvary-Schaefer
2019 - JZP080-301: A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) with an Open-label Safety Extension, Jazz Pharmaceuticals, Site PI: N. Foldvary-Schaefer
2018-2019 An Open Label Expanded Access Program Intended to Provide Treatment with HSB-101 (Pitolisant) to Adult Patients in the U.S. with Excessive Daytime Sleepiness Associated with Narcolepsy with or without Cataplexy, Harmony Biosciences; Site PI: N. Foldvary-Schaefer
2017-2019 A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in Subjects with Narcolepsy with Cataplexy, Jazz Pharmaceuticals; Site PI: N. Foldvary-Schaefer
2015-2018 A Long-Term, Open-Label Safety and Maintenance of Efficacy Study of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Narcolepsy or Obstructive Sleep Apnea, Jazz Pharmaceuticals, Site PI: N. Foldvary-Schaefer
2015-2018 A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy ofJZP-110 [(R)-2-amino-3-phenylpropylcarbamate hydrochloride] in the Treatment of Excessive Sleepiness in Subjects with Obstructive Sleep Apnea, Jazz Pharmaceuticals, Site PI: N. Foldvary-Schaefer
- Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. Malhotra A, Shapiro C, Pepin JL, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Chandler P, Lee L, Schwab R, Sleep. 2019 Nov 6. pii: zsz220. doi: 10.1093/sleep/zsz220. [Epub ahead of print]. PMID: 31691827.
- Effects of Pharmacotherapy Treatment on Patient Reported Outcomes in a Narcolepsy and Idiopathic Hypersomnia Cohort. Pascoe M, Bena J, Foldvary-Schaefer N., J Clin Sleep Med. 2019 Oct 30. pii: jc-19-00234. [Epub ahead of print]. PMID: 31662179.
- Pregnancy and Contraception Experiences in Women With Narcolepsy: A Narcolepsy Network Survey. Pascoe M, Carter LP, Honig E, Bena J, Foldvary-Schaefer N., J Clin Sleep Med. 2019 Oct 15;15(10):1421-1426. doi: 10.5664/jcsm.7966. PMID: 31596206.