Giving People with Narcolepsy the Opportunity for Better Days and Nights

At Avadel, we recognize that narcolepsy is a medical condition that may not be well understood by the general public, so let’s start with some facts:??

• Narcolepsy is a chronic neurologic disorder that affects one in every 2,000 people in the United States.
• For people living with narcolepsy, the lines between being asleep and awake are blurred. Instead of normal sleep patterns, they experience interrupted nightly sleep, as well as episodes of overwhelming urges to sleep while awake – impacting every aspect of their lives.
• During the day, excessive daytime sleepiness (EDS) can lead to missed work, school and time with family and friends.
• During the night, disturbances can keep restorative sleep, that helps people feel refreshed, out of reach.

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It’s estimated that 2/3 of people with narcolepsy experiencing disrupted nighttime sleep; they generally fall asleep quickly, but their sleep is not restorative. Treatment options may be an added burden. Wake-promoting agents and stimulants can cause insomnia, and immediate-release oxybates require patients to forcefully awaken during the middle of the night to take a second dose in order to get the full therapeutic benefit of their treatment, further disrupting an already disrupted sleep schedule.

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I’m proud to share that earlier this week, LUMRYZ? became the first and only FDA approved once-at-bedtime oxybate for the treatment of cataplexy or EDS, in adults living with narcolepsy.

Full Prescribing Information for LUMRYZ is available here . Important safety information can be found below.

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With the approval of LUMRYZ, adults living with narcolepsy can now take a single, bedtime treatment to manage their EDS or cataplexy. LUMRYZ eliminates the need for a second middle-of-the-night dose and the potential for that second dose to be taken too early, too late, or completely missed.

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With once-at-bedtime LUMRYZ, it is our hope that people living with this chronic condition can control their EDS or cataplexy, while not sacrificing their nights.?

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Please note that LUMRYZ has a boxed warning due to sodium oxybate being a central nervous system depressant that has potential for abuse and misuse. Most common adverse reactions (incidence > 5% and greater than placebo) reported for all doses of LUMRYZ combined were nausea, dizziness, enuresis, headache, and vomiting. Like other FDA-approved oxybates, LUMRYZ is available only through a Risk Evaluation and Mitigation Strategy, otherwise known as REMS – a set of safety requirements ensuring physicians formally confirm that patients are screened, educated, prepared, and monitored throughout their treatment.

A sincere thank you

I am deeply appreciative of the patients and investigators who participated in our pivotal Phase 3 REST-ON clinical trial, and our employees, who have remained relentlessly committed to bringing this new treatment option to the narcolepsy community.

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Now that LUMRYZ is approved, we look forward to positively impacting the lives of people living with narcolepsy, both in the near-term and in the future. Patients are, and will always be, at the center of everything we do at Avadel.

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To learn more about Avadel’s mission to transform treatments to transform lives and our enduring commitment to the narcolepsy community, visit www.avadel.com .

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IMPORTANT SAFETY INFORMATION

WARNING: Taking LUMRYZ? (sodium oxybate) with other central nervous system (CNS) depressants such as medicines used to make you fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope), and death.

The active ingredient of LUMRYZ (sodium oxybate) is a form of gamma hydroxybutyrate (GHB), a controlled substance. Abuse or misuse of illegal GHB alone or with other CNS depressants (drugs that cause changes in alertness or consciousness) have caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma, and death. Call your doctor right away if you have any of these serious side effects.

Because of these risks, LUMRYZ is available only by prescription and filled through certified pharmacies in the LUMRYZ REMS program. You must be enrolled in the LUMRYZ REMS to receive LUMRYZ. Further information is available at?www.LUMRYZREMS.com ?or by calling 1-877-453-1029.

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INDICATIONS

LUMRYZ?(sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in adults with narcolepsy:

• sudden onset of weak or paralyzed muscles (cataplexy)
• excessive daytime sleepiness (EDS)

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It is not known if LUMRYZ is safe and effective in people less than 18 years of age.

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Do not take LUMRYZ if you take?other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol, or have a rare problem called succinic semialdehyde dehydrogenase deficiency.

Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling or giving away LUMRYZ 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.

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Anyone who takes LUMRYZ should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least six (6) hours after taking LUMRYZ. Those activities should not be done until you know how LUMRYZ affects you.

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Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized.

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LUMRYZ can cause serious side effects, including the following:

• Breathing problems, including?slower breathing, trouble breathing, and/or short periods of not breathing while sleeping (eg, sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they take LUMRYZ.
• Mental health problems, including?confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness, and difficulty concentrating. Tell your doctor if you have or had depression or have tried to harm yourself.?Call your doctor right away if you have symptoms of mental health problems or a change in weight or appetite.
• Sleepwalking.?Sleepwalking can cause injuries. Call your doctor if you start sleepwalking.

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Tell your doctor if you are on a salt-restricted diet or if you have high blood pressure, heart failure, or kidney problems. LUMRYZ contains a lot of sodium (salt) and may not be right for you.

The most common side effects of LUMRYZ in adults include nausea, dizziness, bedwetting, headache, and vomiting. Your side effects may increase when you take higher doses of LUMRYZ. LUMRYZ can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of LUMRYZ.

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For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

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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.