`UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.…
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`UCB announces NAYZILAM® (midazolam)
`nasal spray now approved by FDA to treat
`intermittent, stereotypic episodes of
`frequent seizure activity in people living
`with epilepsy in the U.S.
`
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`Published: May 20, 2019
`
`NAYZILAM® (midazolam) nasal spray CIV is a nasally
`administered benzodiazepine 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.
`NAYZILAM allows for administration by a non-healthcare
`professional in patients actively seizing when and where a
`seizure cluster occurs.
`Approval of NAYZILAM adds to UCB's already existing anti-
`epilepsy drug portfolio, reinforcing the company's position as a
`global leader in epilepsy.
`
`UCB
`, /PRNewswire/ --
` and BRUSSELS ATLANTA May 20, 2019
`
`
`
` announced
`U.S. Food and Drug Administration (FDA)
`today that the
` has approved
`a New Drug Application for the company's newest anti-epileptic drug
`®
`(AED) NAYZILAM (midazolam) nasal spray CIV, a benzodiazepine
`indicated for the acute treatment of intermittent, stereotypic episodes of
`frequent seizure activity (i.e., seizure clusters, acute repetitive seizures)
`
`https://www.biospace.com/article/releases/ucb-announces-nayzilam-midazolam-nasal-spray-now-approved-by-fda-to-treat-intermittent-stereotypic-episodes-of-frequent-seizure-activity-in-people-living-… 1/14
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`10/31/2019
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`UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.…
`that are distinct from a patient's usual seizure pattern in patients with
`epilepsy 12 years of age and older. NAYZILAM now provides patients and
`caregivers with the first and only FDA-approved nasal option for treating
`seizure clusters.
`
`It is estimated that more than 150,000 people in the U.S. with
`1
`uncontrolled epilepsy also experience seizure clusters.
` Rescue
`treatment of seizure clusters is critical because when left untreated,
`seizure clusters can increase the risk of physical injury, neurological
`2
`damage, prolonged seizures, and status epilepticus.
` Despite the impact
`of seizure clusters, many diagnosed patients may go untreated because
`3, 4, 5, 6
`currently available treatment options are not preferred.
`
`NAYZILAM is a short-term treatment for seizure clusters in patients with
`epilepsy. The nasal spray is designed as a single-use treatment that can
`be carried with a patient. NAYZILAM allows for administration by a non-
`healthcare professional in patients actively seizing when and where a
`seizure cluster occurs. NAYZILAM can provide value to patients who are
`experiencing these disruptive seizures.
`
`"As global leaders in epilepsy, the approval of NAYZILAM complements our
`already strong epilepsy portfolio, improving our ability to provide value to
`https://www.biospace.com/article/releases/ucb-announces-nayzilam-midazolam-nasal-spray-now-approved-by-fda-to-treat-intermittent-stereotypic-episodes-of-frequent-seizure-activity-in-people-living-… 2/14
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`10/31/2019
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`UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.…
`people living with poorly controlled seizures, and builds on our passion and
`expertise in this field. We are pleased to expand and diversify the solutions
`we can offer to the epilepsy community, providing an innovative and
`differentiated solution to help support management of seizure clusters," said
`, Chief Executive Officer, UCB.Jean-Christophe Tellier
`
`
`NAYZILAM is the first new medication approved to treat seizure clusters
`in more than 20 years in the U.S. Its nasal delivery could provide
`significant value to patients who currently have limited treatment
`options.
`
`"When a patient experiences seizure clusters, there is often significant impact
`on their overall quality of life, in addition to posing greater risks for increased
`emergency department related hospitalizations and more serious seizure
`
`emergencies," said Dr. Steven S. Chung, MD, Executive Director and Program
`
`Chair of the Neuroscience Institute and Director of the Epilepsy Program at
`Banner – University Medical Center. "Further, as a neurologist specializing in
`epilepsy, treating seizure clusters today presents a challenging barrier for
`many patients. The availability of a new treatment option, such as NAYZILAM,
`has potential to help improve the lives of patients and their families by
`providing another option for rescue care."
`
`
`
`UCB acquired NAYZILAM from Proximagen LLC in June 2018. UCB looks
`forward to NAYZILAM launching in the U.S. To learn more, go to
`www.Nayzilam.com
`.
`
`About NAYZILAM
`®
`NAYZILAM (midazolam) nasal spray CIV is a benzodiazepine 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.
`
`https://www.biospace.com/article/releases/ucb-announces-nayzilam-midazolam-nasal-spray-now-approved-by-fda-to-treat-intermittent-stereotypic-episodes-of-frequent-seizure-activity-in-people-living-… 3/14
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`10/31/2019
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`UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.…
`The effectiveness of NAYZILAM 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 was
`established in a randomized, double-blind, placebo-controlled trial
`(Study 1; NCT 01390220). Study 1 enrolled patients with epilepsy on a
`stable regimen of antiepileptic drugs who were identified by their
`physicians as having intermittent, stereotypic episodes of frequent
`seizure activity that were distinct from the patient's usual seizure
`pattern.
`
`Study 1 was conducted in two phases: an open-label Test Dose Phase
`followed by a randomized, double-blind, placebo-controlled,
`Comparative Phase. In the Test Dose Phase, tolerability was assessed in
`292 patients who, in the absence of a seizure, received two 5 mg doses
`of NAYZILAM (10 mg total dosage) separated by 10 minutes. Patients
`were excluded from participation in the Comparative Phase if they failed
`to meet pre-defined blood pressure, heart rate, sedation,
`electrocardiogram, and peripheral oxygen saturation criteria.
`
`In the Comparative Phase, 201 patients treated a single seizure cluster
`episode in an outpatient setting with either a blinded dose of NAYZILAM
`5 mg (134 patients) or placebo (67 patients). If the seizure activity
`persisted or recurred, patients in both groups had the option to receive a
`subsequent unblinded dose of NAYZILAM 5 mg to be used between 10
`minutes and 6 hours after administration of the initial blinded dose of
`study drug.
`
`The primary efficacy endpoint for Study 1 was treatment success,
`defined as the termination of seizures within 10 minutes after the initial
`blinded dose of study drug and the absence of a recurrence of seizures
`within 6 hours of the initial blinded dose of study drug. A statistically
`
`https://www.biospace.com/article/releases/ucb-announces-nayzilam-midazolam-nasal-spray-now-approved-by-fda-to-treat-intermittent-stereotypic-episodes-of-frequent-seizure-activity-in-people-living-… 4/14
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`UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.…
`significantly higher percentage of NAYZILAM-treated patients met the
`primary efficacy endpoint. Numerical differences in favor of NAYZILAM
`were observed on each of the components of the treatment success
`responder definition; termination of seizure(s) within 10 minutes after
`initial dose of study drug (80.6 versus 70.1%) and the absence of seizure
`recurrence between 10 minutes and 6 hours after the initial dose of
`study drug (58.2 versus 37.3%). The most common adverse reactions
`(≥5% in any NAYZILAM treatment group) were somnolence, headache,
`nasal discomfort, throat irritation, and rhinorrhea.
`
`Study 1 also evaluated the occurrence and time to next seizure after the
`initial blinded dose of study drug. A smaller proportion of NAYZILAM-
`treated patients experienced the next seizure within 24 hours after the
`initial blinded dose of study drug (37.3% versus 46.3%). NAYZILAM-
`treated patients experienced a statistically longer time-to-next-seizure
`than the placebo group.
`
`About Epilepsy7, 8, 9, 10
`Epilepsy is a chronic neurological disorder of the brain. It is the fourth
`most common neurological condition worldwide and affects
`approximately 65 million people. In the U.S. more than 3.4 million people
`have epilepsy. Anyone can develop epilepsy; it occurs across all ages,
`races and genders, and is defined as one or more unprovoked seizures
`with a risk of further seizures. Around one third of patients with epilepsy
`currently live with uncontrolled seizures.
`
`About Seizure Clusters
`Of the one third of patients living with uncontrolled epilepsy, it is
`estimated that more than 150,000 people in the U.S. with refractory
`1
`epilepsy also experience seizure clusters.
` Seizure clusters are broadly
`defined as acute episodes of consecutive seizures that occur within a
`
`https://www.biospace.com/article/releases/ucb-announces-nayzilam-midazolam-nasal-spray-now-approved-by-fda-to-treat-intermittent-stereotypic-episodes-of-frequent-seizure-activity-in-people-living-… 5/14
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`UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.…
`short period of time with a patient regaining consciousness during the
`interictal period. These clusters are also distinguishable from a person's
`1, 11, 12, 13, 14
`typical seizure pattern.
` Other names for seizure clusters
`include acute-repetitive seizures (ARS), serial seizures, crescendo
`seizures, and seizure flurries, which highlight the repetitive nature of the
`15
`seizures.
`Seizure clusters are a form of seizure emergency that can
`2
`evolve into prolonged seizures or status epilepticus.
`
`About UCB in Epilepsy
`UCB has a rich heritage in epilepsy with over 20 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.
`
`Important Safety Information for NAYZILAM
`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.
`
`CONTRAINDICATIONS
`NAYZILAM is contraindicated in patients with acute narrow-angle
`glaucoma.
`
`https://www.biospace.com/article/releases/ucb-announces-nayzilam-midazolam-nasal-spray-now-approved-by-fda-to-treat-intermittent-stereotypic-episodes-of-frequent-seizure-activity-in-people-living-… 6/14
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`UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.…
`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 use in
`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.
`
`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.
`
`https://www.biospace.com/article/releases/ucb-announces-nayzilam-midazolam-nasal-spray-now-approved-by-fda-to-treat-intermittent-stereotypic-episodes-of-frequent-seizure-activity-in-people-living-… 7/14
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`UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.…
`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
`
`https://www.biospace.com/article/releases/ucb-announces-nayzilam-midazolam-nasal-spray-now-approved-by-fda-to-treat-intermittent-stereotypic-episodes-of-frequent-seizure-activity-in-people-living-… 8/14
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`10/31/2019
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`UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.…
`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 the full Prescribing Information at www.Nayzilam.com.
`
`
`
`For additional medical information about NAYZILAM, patient assistance,
`
`or any other information please visit our website or call ucbCARES at 1-
`
`844-599-2273.
`
`®
`Nayzilam is a registered trademark of UCB Biopharma SPRL.
`
`©2019 UCB, Inc., Smyrna, GA 30080. All rights reserved.
`
`
`For further information:
`
`Corporate Communications
`
`Erica Puntel
`
`U.S. Communications, UCB
`
`Investor Relations
`
`T +404.938.5359
`
`Antje Witte,
`
`Erica.Puntel@ucb.com
`
`Investor Relations, UCB
`
`France Nivelle
`
`T+32.2.559.94.14,
`
`Global Communications, UCB
`
`antje.witte@ucb.com
`
`T+32.2.559.9178,
`
`France.nivelle@ucb.com
`
`Jim Baxter
`
`Isabelle Ghellynck,
`
`Neurology Communications, UCB
`
`Investor Relations, UCB
`
`https://www.biospace.com/article/releases/ucb-announces-nayzilam-midazolam-nasal-spray-now-approved-by-fda-to-treat-intermittent-stereotypic-episodes-of-frequent-seizure-activity-in-people-living-… 9/14
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`UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.…
`T+32.2.473.78.85.01,
`T +32.2.559.9588,
`
`jim.baxter@ucb.com
`
`isabelle.ghellynck@ucb.com
`
`Laurent Schots
`
`Media Relations, UCB
`
`T+32.2.559.92.64,
`
`laurent.schots@ucb.com
`
`About UCB
`
`
`
`UCB, Brussels, Belgium www.ucb.com ( ) is a global biopharmaceutical
`company focused on the discovery and development of innovative
`medicines and solutions to transform the lives of people living with
`severe diseases in immunology or neurology. With around 7 500 people,
`operating in 40 countries, the company generated revenue of € 4.6
`billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow
`us on Twitter: @UCBUSA
`
`Forward looking statements
`This press release contains forward-looking statements based on current
`plans, estimates and beliefs of management. All statements, other than
`statements of historical fact, are statements that could be deemed
`forward-looking statements, including estimates of revenues, operating
`margins, capital expenditures, cash, other financial information,
`expected legal, political, regulatory or clinical results and other such
`estimates and results. By their nature, such forward-looking statements
`are not guarantees of future performance and are subject to risks,
`uncertainties and assumptions which could cause actual results to differ
`materially from those that may be implied by such forward-looking
`statements contained in this press release. Important factors that could
`result in such differences include: changes in general economic, business
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`and competitive conditions, the inability to obtain necessary regulatory
`approvals or to obtain them on acceptable terms, costs associated with
`research and development, changes in the prospects for products in the
`pipeline or under development by UCB, effects of future judicial
`decisions or governmental investigations, product liability claims,
`challenges to patent protection for products or product candidates,
`changes in laws or regulations, exchange rate fluctuations, changes or
`uncertainties in tax laws or the administration of such laws and hiring
`and retention of its employees.
`
`Additionally, information contained in this document shall not constitute
`an offer to sell or the solicitation of an offer to buy any securities, nor
`shall there be any offer, solicitation or sale of securities in any
`jurisdiction in which such offer, solicitation or sale would be unlawful
`prior to the registration or qualification under the securities laws of such
`jurisdiction. UCB is providing this information as of the date of this
`document and expressly disclaims any duty to update any information
`contained in this press release, either to confirm the actual results or to
`report a change in its expectations.
`
`There is no guarantee that new product candidates in the pipeline will
`progress to product approval or that new indications for existing
`products will be developed and approved. Products or potential products
`which are the subject of partnerships, joint ventures or licensing
`collaborations may be subject to differences between the partners. Also,
`UCB or others could discover safety, side effects or manufacturing
`problems with its products after they are marketed.
`
`Moreover, sales may be impacted by international and domestic trends
`toward managed care and health care cost containment and the
`reimbursement policies imposed by third-party payers as well as
`legislation affecting biopharmaceutical pricing and reimbursement.
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`References:
`
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`Buchsbaum R, Detyniecki K. Prevalence and risk factors of seizure
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`
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` 2019;92:53-56.
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`5. de Haan GJ, van der Geest P, Doelman G, Bertram E, Edelbroek P. A
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`.
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`2010;51(3):478-482
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`
`.March 2019
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` accessed http://www.epilepsy.com/learn/about-epilepsy-basics 27
`
`
`.March 2019
`
`
`
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`https://www.biospace.com/article/releases/ucb-announces-nayzilam-midazolam-nasal-spray-now-approved-by-fda-to-treat-intermittent-stereotypic-episodes-of-frequent-seizure-activity-in-people-living… 12/14
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`UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.…
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` accessedhttp://www.epilepsy.com/learn/epilepsy-101/what-epilepsy
`
`.27 March 2019
`10. The Epilepsy Foundation of America. Who gets epilepsy?
`.http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy
`
`accessed 27 March 2019
`11. Mitchell WG. Status epilepticus and acute repetitive seizures in
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`treatment. Epilepsia. 1996;37 Suppl 1:S74-S80.
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`13. Dreifuss FE, Rosman NP, Cloyd JC, et al. A comparison of rectal
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`doi:10.1016/j.seizure.2018.05.013
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`US-P-NZ-SC-1900024
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`multimedia:http://www.prnewswire.com/news-releases/ucb-announces-
`nayzilam-midazolam-nasal-spray-now-approved-by-fda-to-treat-
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`https://www.biospace.com/article/releases/ucb-announces-nayzilam-midazolam-nasal-spray-now-approved-by-fda-to-treat-intermittent-stereotypic-episodes-of-frequent-seizure-activity-in-people-living… 13/14
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`Neurelis - EX. 2018
`Aquestive Therapeutics, Inv. v. Neurelis, Inc. - IPR2019-00451
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`10/31/2019
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`UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.…
`intermittent-stereotypic-episodes-of-frequent-seizure-activity-in-people-
`living-with-epilepsy-in-the-us-300852851.html
`
`SOURCE UCB, Inc.
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`Company Codes:
`EuronextBrussels:UCB, OTC-PINK:UCBJY
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`Neurelis - EX. 2018
`Aquestive Therapeutics, Inv. v. Neurelis, Inc. - IPR2019-00451
`
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