Jazz Pharmaceuticals Announces U.S. FDA Approval of Sunosi™ (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
Sunosi is expected to be commercially available in the U.S. following the final scheduling decision by the
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"Excessive daytime sleepiness can negatively impact the daily lives of people living with narcolepsy or obstructive sleep apnea at work, at home or in daily activities. With this approval, a new, daytime medicine that can provide sustained wakefulness throughout the day will be available for patients," said
At Week 12, 150 mg of Sunosi for narcolepsy patients and all doses for OSA patients demonstrated improvements in wakefulness compared to placebo as assessed in test sessions 1 (approximately one hour post-dose) through 5 (approximately nine hours post-dose) of the maintenance of wakefulness test (MWT).
"We're excited about this new therapeutic option for patients, and we are pleased with the information included in the Sunosi label as we believe it will give physicians the information needed to appropriately manage the vast majority of obstructive sleep apnea and narcolepsy patients with excessive daytime sleepiness," said
In 12 week clinical studies, approximately 68-74% of people taking Sunosi at the 75 mg dose and 78-90% of people taking Sunosi at the 150 mg dose reported improvement in their overall clinical condition, as assessed by the Patient Global Impression of Change (PGIc) scale.
Although the exact mechanism of action is unknown, the effects of Sunosi are thought to be mediated through its activity as a DNRI.
"Sunosi is an effective treatment option with a novel mechanism of action as a dual-acting dopamine and norepinephrine reuptake inhibitor," said
Sunosi is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating Sunosi for excessive daytime sleepiness in OSA. Modalities to treat the underlying airway obstruction should be continued during treatment with Sunosi. Sunosi is not a substitute for these modalities.
More information about Sunosi, including Full Prescribing Information and Medication Guide, is available here.
About Sunosi™ (solriamfetol)
Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA). In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize Sunosi from Aerial Biopharma.
Important Safety Information
SUNOSI can be a target for people who abuse prescription medicines or street drugs. Keep SUNOSI in a safe place to protect it from theft. Never give your SUNOSI to anyone else, because it may cause death or harm them. Selling or giving away SUNOSI may harm others and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Do not take SUNOSI if you are taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).
Before taking SUNOSI, tell your doctor about all of your medical conditions, including if you:
- have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol
- have had a heart attack or a stroke
- have kidney problems or diabetes
- have a history of mental health problems, (including psychosis and bipolar disorders), or of drug or alcohol abuse or addiction
- are pregnant or planning to become pregnant. It is not known if SUNOSI will harm your unborn baby.
- Pregnancy Registry: There is a pregnancy registry for women who take SUNOSI during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.
- are breastfeeding or plan to breastfeed. It is not known if SUNOSI passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SUNOSI.
Especially tell your healthcare provider if you take a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).
What are the possible side effects of SUNOSI?
SUNOSI may cause serious side effects, including:
- Increased blood pressure and heart rate. SUNOSI can cause blood pressure and heart rate increases that can increase the risk of heart attack, stroke, heart failure and death. Your doctor should check your blood pressure before you start and during treatment with SUNOSI. Your doctor may decrease your dose or tell you to stop taking SUNOSI if you develop high blood pressure that does not go away during treatment with SUNOSI.
- Mental (psychiatric) symptoms including anxiety, problems sleeping (insomnia), irritability and agitation. Tell your doctor if you develop anxiety, problems sleeping, irritability, agitation. Your doctor may change your dose or tell you to stop taking SUNOSI if you develop side effects during treatment with SUNOSI.
The most common side effects of SUNOSI include:
- decreased appetite
- problems sleeping
These are not all the possible side effects of SUNOSI. Call your doctor for advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the
About Obstructive Sleep Apnea and Excessive Daytime Sleepiness
Obstructive sleep apnea, commonly referred to as sleep apnea, is a highly prevalent disease (as high as 14% in men and 5% in women) in which excessive daytime sleepiness is a major presenting complaint in many cases.1-4 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 apnea that frequently results in improvement in excessive daytime sleepiness in many patients; however, not all patients tolerate CPAP therapy and among those who tolerate CPAP, usage is highly variable. Excessive daytime sleepiness may persist in people with sleep apnea despite using CPAP.
Narcolepsy is a chronic, debilitating neurological disorder characterized by excessive daytime sleepiness, and the inability to regulate sleep-wake cycles normally.5 It affects an estimated one in 2,000 people in the United States, with symptoms typically appearing in childhood. It is estimated that more than 50% of patients with narcolepsy have not been diagnosed.6 Studies have shown it may take 10 years or more for people with narcolepsy to receive a diagnosis.7 Excessive daytime sleepiness is the primary symptom of narcolepsy and is present in all people with the disorder.8 Excessive daytime sleepiness is characterized by the inability to stay awake and alert during the day resulting in unplanned lapses into sleep or drowsiness.6,8,9 There are five primary symptoms of narcolepsy, including excessive daytime sleepiness, cataplexy, sleep-related hallucinations, sleep paralysis and sleep disruption. While all patients with narcolepsy experience excessive daytime sleepiness, they may not experience all five symptoms.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the potential benefits of Sunosi, the expected timing of the commercial launch of Sunosi in the U.S., the company's belief that the Sunosi label will give physicians the information needed to appropriately manage the vast majority of OSA and narcolepsy patients with excessive daytime sleepiness, and other statements that are not historical facts. These forward-looking statements are based on the company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: the company's ability to effectively commercialize Sunosi in the U.S.; delays or problems in the supply or manufacture of Sunosi; obtaining and maintaining appropriate pricing and reimbursement for Sunosi; complying with applicable U.S. regulatory requirements; any delays in, or the outcome of, DEA scheduling for Sunosi; and other risks and uncertainties affecting the company, including those described from time to time under the caption "Risk Factors" and elsewhere in
1. Sleepfoundation.org. (2019). Sleep Apnea |
3. Peppard AE, et al. Increased Prevalence of Sleep-Disordered Breathing in Adults. Am J Epidemiol. 2013;177(9):1006-1014.
4. Ye, L. (2014). The different clinical faces of obstructive sleep apnoea: a cluster analysis.
5. Thorpy, M. and Krieger, A. (2014). Delayed diagnosis of narcolepsy: characterization and impact. Sleep Medicine, 15(5), pp.502-507.
6. Ahmed I, Thorpy, M. Clinical Features, Diagnosis and Treatment of Narcolepsy. Clin Chest Med. 2010;31(2):371-381.
7. Morrish E, King M, et al. Factors associated with a delay in the diagnosis of narcolepsy. Sleep Medicine. 2004;5(1):37-41.
8. Sateia, M. (2014). International Classification of Sleep Disorders-Third Edition. Chest, 146(5), pp.1387-1394.
9. Ahmed I, Thorpy, M. Sleepiness: Causes, Consequences and Treatment, ed. Cambridge
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