Jazz Pharmaceuticals Submits Marketing Authorization Application to European Medicines Agency for Solriamfetol as a Treatment to Improve Wakefulness and Reduce Excessive Daytime Sleepiness in Adult Patients with Narcolepsy or Obstructive Sleep Apnea
"Excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea can be debilitating for patients and challenging for the medical community to diagnose and treat," said
Jazz has studied solriamfetol extensively via the Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) Phase 3 program, which was comprised of four studies that evaluated:
- solriamfetol in
EDSin adult patients with narcolepsy (TONES 2) or OSA (TONES 3 and TONES 4), and
- the long-term safety and maintenance of efficacy for solriamfetol as a treatment for
EDSin patients with narcolepsy or OSA (TONES 5).
Jazz presented long-term safety and maintenance of efficacy results from the TONES 5 Phase 3 study of solriamfetol in adult patients with
Notes to Editors
About Obstructive Sleep Apnea and Excessive Daytime Sleepiness
In the EU, obstructive sleep apnea (OSA) is a prevalent disease (as high as 14% in men and 7% in women) in which excessive daytime sleepiness is a major presenting complaint in many cases.1 Excessive daytime sleepiness in OSA is associated with impairments in cognitive function, safety, productivity, interpersonal relationships, and overall quality of life. Positive Airway Pressure (PAP) therapy, with its most common form being Continuous Positive Airway Pressure (CPAP), has been shown to be an effective therapy for sleep-related airway obstruction, with frequent improvement in excessive daytime sleepiness in many patients; however, pathological sleepiness often continues despite primary treatment of the airway obstruction with PAP or other therapies.2-5 It is estimated that excessive daytime sleepiness persists in one in three people utilizing CPAP for OSA.6
About Narcolepsy and Excessive Daytime Sleepiness
Narcolepsy is a debilitating neurological disorder characterized by excessive daytime sleepiness, and the inability to regulate sleep-wake cycles normally.7 It affects an estimated one in 2,000 people in the EU,8 with symptoms typically appearing in early adulthood. Globally, it is estimated that more than 50% of patients with narcolepsy have not been diagnosed.9 Studies have shown it may take 10 years or more for people with narcolepsy to receive a correct diagnosis.10 Excessive daytime sleepiness is the primary symptom of narcolepsy and is present in all people with the disorder.11 Excessive daytime sleepiness is characterized by the inability to stay awake and alert during the day, resulting in unplanned drowsiness or lapses into sleep.7, 11,12
Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in development for treatment of
- Jennum P, Riha RL. Epidemiology of sleep apnoea/hypopnoea syndrome and sleep-disordered breathing. Eur Respir J. 2009 Apr;33(4):907-14.
- Pepin JL, et al. Eur Resp J. 2009;33:1062–1067.
- Weaver TE, et al. Sleep. 2007;30(6):711–719.
- Gasa M, et al. J Sleep Res. 2013;22(4):389–397.
- Koutsourelakis I, et al. Eur Resp J. 2009;34(3):687–693.
- Antic N, et al. The Effect of CPAP in Normalizing Daytime Sleepiness, Quality of Life, and Neurocognitive Function in Patients with Moderate to Severe OSA. Sleep. 2011:34(1)111-119.
- Thorpy M, Krieger A. Delayed diagnosis of narcolepsy: characterization and impact. Sleep Medicine. 2014;15(5):502–507.
- Ohayon MM et al. Prevalence of narcolepsy symptomatology and diagnosis in the European general population; Neurology 2002, 58. 1826-1833.
- Ahmed I, Thorpy, M. Clinical Features, Diagnosis and Treatment of Narcolepsy. Clin Chest Med. 2010;31(2):371-381.
- Morrish E, King M, et al. Factors associated with a delay in the diagnosis of narcolepsy. Sleep Medicine. 2004;5(1):37-41.
American Academy of Sleep Medicine. The International Classification of Sleep Disorders. Third Edition (ICSD-3). 2014.
- Ahmed I, Thorpy, M. Sleepiness: Causes, Consequences and Treatment, ed. Cambridge
University Press. 2011:36-49.
View original content to download multimedia:http://www.prnewswire.com/news-releases/jazz-pharmaceuticals-submits-marketing-authorization-application-to-european-medicines-agency-for-solriamfetol-as-a-treatment-to-improve-wakefulness-and-reduce-excessive-daytime-sleepiness-in-adult-patients-with-narcolepsy-or-obst-300747377.html
Media Contact: Jacqueline Kirby, Vice President, Corporate Affairs & Government Relations, Ireland +353 1 697 2141, U.S. +1 215 867 4910; Investor Contact: Kathee Littrell, Vice President, Investor Relations, Ireland +353 1 634 7887, U.S. +1 650 496 2717