Axsome Therapeutics Hosts Sunosi® Investor Update Virtual Event Today with Key Opinion Leaders
The event will include clinical overviews of current and potential future indications provided by three key opinion leaders (KOLs). The Axsome senior management team will also provide an overview of Sunosi commercial activities and clinical development plans. The presenters will be available to answer questions at the end of the presentations. To access the event please click here.
Presenting Key Opinion Leaders (KOLs):
Richard K. Bogan, MD, FCCP, Principal of Bogan Sleep Consultants, Associate Clinical Professor at the University of South Carolina School of Medicine, and Associate Clinical Professor at Medical University of South Carolina. Dr. Boganwill provide an overview of excessive daytime sleepiness associated with narcolepsy. Andrew Krystal, MD, Ray and Dagmar Dolby Distinguished Professor of Psychiatry and Neurology at UCSF Weill Institute for Neurosciences, and Vice-Chair for Research in the Department of Psychiatry. Dr. Krystalwill provide an overview of excessive daytime sleepiness in obstructive sleep apnea. Stephen V. Faraone, PhD, Distinguished Professor in the Departments of Psychiatry and Neuroscience & Physiology at SUNY Upstate Medical Universityand Vice-Chair for Research in the Department of Psychiatry. Dr. Faraonewill provide an overview of attention deficit hyperactivity disorder (ADHD).
The live webcast may be accessed on the "Webcasts & Presentations" page of the "Investors" section of the Axsome website at axsome.com. A replay of the webcast will be available for approximately 30 days following the live event.
About Sunosi® (solriamfetol)
Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor shown to improve wakefulness in adults living with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA). Sunosi received
More information about Sunosi, including Full Prescribing Information and Medication Guide, is available here.
Important Safety Information
SUNOSI (solriamfetol) is available in 75 mg and 150 mg tablets and is a federally controlled substance (CIV) because it contains solriamfetol that 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 or sell your SUNOSI to anyone else because it may cause death or harm them and it is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
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 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.
- 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.
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, 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 any of these symptoms. 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 FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please find full Prescribing Information here: https://sunosihcp.com/assets/files/sunosi-pi.pdf
SUN CON ISI 05/2022
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. 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 serious and debilitating neurological condition that causes dysregulation of the sleep-wake cycle and is characterized clinically by excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nocturnal sleep. Narcolepsy afflicts an estimated 185,000 individuals in the
Forward Looking Statements
Certain matters discussed in this press release are "forward-looking statements". We may, in some cases, use terms such as "predicts," "believes," "potential," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company's statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of our Sunosi® product and the success of our efforts to obtain any additional indication(s) with respect to Sunosi®; the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application ("NDA") for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain
Chief Operating Officer
Source: Axsome Therapeutics, Inc.