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Nov 30
FDA Approves Shelf Life Extension for NAYZILAM® (midazolam) Nasal Spray, CIV

The U.S. Food and Drug Administration has reviewed new drug stability data and approved a shelf life extension from 12 to 24 months for NAYZILAM® (midazolam) nasal spray, CIV. NAYZILAM is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older.1

Patients and caregivers who have been prescribed NAYZILAM will now receive their medication with an extended expiry date of up to 24 months. NAYZILAM was first approved two years ago by the FDA.

NAYZILAM is the #1 prescribed branded nasal spray rescue treatment on the market.*

The approval of NAYZILAM was based on a placebo-controlled trial, with a primary efficacy endpoint of treatment success, defined by 2 components: seizure termination within 10 minutes and no seizure recurrence within 6 hours. 

NAYZILAM helped the majority of patients stop a seizure cluster within 10 minutes and helped patients return to baseline function in approximately 90 minutes.1-3†‡ Additionally, patients treated with NAYZILAM had a greater probability of not experiencing more seizures for 24 hours after treatment with NAYZILAM compared with placebo.

NAYZILAM has a Boxed Warning for concomitant use with opioids, abuse, misuse, and addiction, dependence and withdrawal reactions.  The most common adverse reactions (≥5% in any NAYZILAM treatment group) were somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea.   Midazolam is associated with a high incidence of partial or complete impairment of recall for the next several hours.1

It is estimated that more than 150,000 people in the U.S. with uncontrolled epilepsy also experience seizure clusters.4 Rescue treatment of seizure clusters is critical because, when left untreated, seizure clusters can increase the risk of physical injury, neurological damage, prolonged seizures, and status epilepticus.5 Seizure clusters are a form of seizure emergency that can evolve into prolonged seizures or status epilepticus.5

For additional medical information about NAYZILAM, patient assistance, or other information, please visit NAYZILAM.com or call ucbCARES® at 1-844-599-2273.

*IQVIA National Prescription Audit™. Based on 12-month data (8/20-7/21); U.S. Epilepsy Main Market; Patients 12 years and older. 
† Exploratory endpoint: Time to return to full baseline functionality as determined by the caregiver
‡ (range, 1.1–2.0 h)

About Epilepsy
Epilepsy is a chronic neurological disorder of the brain.6 It is the fourth most common neurological condition worldwide and affects approximately 65 million people.7 Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked epileptic seizures with a risk of further seizures.7

About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 30 years of experience in the research and development of anti-epileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies, and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support patients with epilepsy. 

NAYZILAM INDICATION AND IMPORTANT SAFETY INFORMATION1 

NAYZILAM was approved by the FDA in May 2019 for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older. 

CONTRAINDICATIONS
NAYZILAM is contraindicated in patients with acute narrow-angle glaucoma.

RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines, including NAYZILAM, and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.

ABUSE, MISUSE, AND ADDICTION
The use of benzodiazepines, including NAYZILAM, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing NAYZILAM and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.

DEPENDENCE AND WITHDRAWAL REACTIONS USE OF NAYZILAM MORE FREQUENTLY THAN RECOMMENDED
The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although NAYZILAM is indicated only for intermittent use, if used more frequently than recommended abrupt discontinuation or rapid dosage reduction of NAYZILAM may precipitate acute withdrawal reactions, which can be life-threatening. For patients using NAYZILAM more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue NAYZILAM.


RISKS OF CARDIORESPIRATORY ADVERSE REACTIONS
Serious cardiorespiratory adverse reactions have occurred after administration of midazolam. Warn patients and caregivers about the risks of respiratory depression, cardiac and respiratory arrest.
Respiratory depression was observed with the administration of NAYZILAM during clinical trials. Cardiac or respiratory arrest caused by NAYZILAM was not reported during clinical trials.

CENTRAL NERVOUS SYSTEM DEPRESSION FROM CONCOMITANT USE WITH OTHER CENTRAL NERVOUS SYSTEM DEPRESSANTS, OR MODERATE OR STRONG CYP3A4 INHIBITORS
Drug products containing midazolam, including NAYZILAM, have a central nervous system (CNS) depressant effect. 

Risks from Concomitant Use with Other CNS Depressants
NAYZILAM may cause an increased CNS-depressant effect when used with alcohol or other CNS depressants (e.g., opioids). Warn patients and caregivers that the use of NAYZILAM in combination with alcohol or other CNS depressant drugs may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

Risks from Concomitant Use with Moderate or Strong CYP3A4 Inhibitors
Concomitant use of NAYZILAM with moderate or strong CYP3A4 enzyme inhibitors may result in prolonged sedation because of a decrease in plasma clearance of midazolam. Caution patients against engaging in hazardous occupations requiring mental alertness, such as operating machinery, driving a motor vehicle or riding a bicycle until they have completely returned to their level of baseline functioning.

SUICIDAL BEHAVIOR AND IDEATION
Antiepileptic drugs (AEDs), including NAYZILAM, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor patients treated with NAYZILAM for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Advise patients and caregivers to be alert for these behavioral changes and to immediately report them to the healthcare provider.

IMPAIRED COGNITIVE FUNCTION
Midazolam, including NAYZILAM, is associated with a high incidence of partial or complete impairment of recall for several hours following an administered dose. Counsel patients on when they can engage in activities requiring complete mental alertness, operate hazardous machinery, or drive a motor vehicle after taking NAYZILAM.

GLAUCOMA
Benzodiazepines, including NAYZILAM, can increase intraocular pressure in patients with glaucoma. NAYZILAM may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. NAYZILAM is contraindicated in patients with narrow-angle glaucoma.

ADVERSE REACTIONS
In the randomized, double-blind, placebo-controlled trial, the most common adverse reactions (≥5% in any NAYZILAM treatment group) were somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea.

NAYZILAM is a Schedule IV controlled substance.

Please refer to full Prescribing Information. 

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NAYZILAM® and ucbCARES® are registered trademarks of the UCB Group of Companies. 
©2021 UCB, Inc., Smyrna, GA 30080. All rights reserved.  
US-P-NZ-SC-2100117 


References: 
1. NAYZILAM® (midazolam): US prescribing information. Smyrna (GA): UCB, Inc. 
2. UCB, Data on File. Proximagen, P261-401 Tables. 
3. Detyniecki K, Van Ess PJ, Sequeira DJ, et al. Safety and efficacy of midazolam nasal spray in the outpatient treatment of patients with seizure clusters—a randomized, double-blind, placebo-controlled trial. Epilepsia. 2019;60:1797-1808. 
4. Chen B, Choi H, Hirsch L, et al. Prevalence and risk factors of seizure clusters in adult patients with epilepsy. Epilepsy Res. 2017;133:98-102.
5. Penovich PE, Buelow J, Steinberg K, Sirven J, Wheless J. Burden of seizure clusters on patients with epilepsy and caregivers: survey of patient, caregiver, and clinician perspectives. Neurologist. 2017;22(6):207-214. 
6. The Epilepsy Foundation of America. About epilepsy basics. http://www.epilepsy.com/learn/about-epilepsy-basics. Accessed 3 August 2021.
7. The Epilepsy Foundation of America. Who gets epilepsy? http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy. Accessed 3 August 2021.
 

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