UCB (EBR:UCB) UCB Media Room - Press release: NAYZILAM® now available

Directive transparence : information réglementée

25/11/2019 13:31
https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQB3Ot-= 2BpMc7pD4jxEXaKFDl75BCXo9Kd9lxroPtRmR-2FZ9pPwgIm2i6G4QQ1SA9zeLzCANP-2BptEYq= nBVoeZWYyhXhxSZYxifUl1I5cGegCpdUtOpvP6pjnHq9-2FC0WgOJG8g0DUGTwaaWGksVKPGaec= CUv4-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQ= R0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsACe2NM5v3jMK267vkr9TRVKV-2BE90z31= tHMhDimwQyJUzr3TP-2FFVBZrSq3-2F5xjn6pvWMbNV68KhQ7IEPq43Tr1M9tAprllEdX4nT7jf= BYPqMd37w0vqmrCTIvG9PosaX8vBlZ7LWa5g14PUvXNlIjQZSGRL7zOs2dY-2FLO3qp2QqeGehK= eV6S4qAd0crBgfy1U-2FjhJmmnMgoQgwa2jVrqHQAeymRAMXQkcLJQlgiCzfqFsnDTXhGE2WErV= yGf1Ar8nFM-3D ** UCB Announces availability of NAYZILAM^=C2=AE (midazolam) Nasal Spray CI= V, the first and only nasal rescue treatment for seizure clusters in the U.= S. ------------------------------------------------------------ =C2=B7 NAYZILAM will be available in retail pharmacies on December 2, 2019 =C2=B7 Copay support and a patient assistance program will be provided by U= CB for eligible NAYZILAM patients*=C2=A0 Atlanta, Georgia (USA), November 25, 2019:=C2=A0=C2=A0UCB announced today t= hat NAYZILAM^=C2=AE (midazolam) nasal spray CIV will be available in retail= pharmacies on December 2, 2019, for the acute treatment of intermittent, s= tereotypic episodes of frequent seizure activity (i.e., seizure clusters, a= cute repetitive seizures) that are distinct from a patient=E2=80=99s usual = seizure pattern in patients with epilepsy 12 years of age and older.^1=C2= =A0 NAYZILAM is the first and only rescue nasal treatment approved to treat sei= zure clusters in the U.S. NAYZILAM is a ready-to-use solution that can be u= sed when and where a seizure cluster occurs and can be administered by a no= n-healthcare professional to a patient during or after a seizure within a c= luster.^1 As with all benzodiazepines, including NAYZILAM, concomitant use = of benzodiazepines and opioids may result in profound sedation, respiratory= depression, coma, and death.^1 =E2=80=9CDelivering another of the six potential new product launches, a UC= B mission over the next five years, NAZYILAM builds on UCB=E2=80=99s commit= ment to addressing the unmet needs of people living with epilepsy,=E2=80=9D= said Mike Davis, Head of Neurology in the U.S., UCB. =C2=A0=E2=80=9CFor th= e first time, people 12 years and older now have a nasally administered res= cue therapy shown to help manage seizure clusters. NAZYILAM can be administ= ered anywhere seizure clusters strike, allowing families to take back valua= ble moments that would otherwise be lost.=E2=80=9D It is estimated that more than 150,000 people in the U.S. with uncontrolled= epilepsy also experience seizure clusters.^2-4 Rescue treatment of seizure= clusters is critical because when left untreated, seizure clusters can inc= rease the risk of physical injury, neurological damage, and status epilepti= cus.^5-8 Despite the impact of seizure clusters, many diagnosed patients ma= y go untreated because currently available treatment options are not prefer= red.^9-12 Currently, only one in five people living with seizure clusters r= eport using a rescue treatment.5 Many patients seek care in the emergency d= epartment.^5 =E2=80=9CSeizure clusters are a medical emergency that can have very seriou= s consequences for those living with them,=E2=80=9D said Dr. Laura Lubbers,= Chief Scientific Officer, Citizens United for Research in Epilepsy (CURE).= =E2=80=9CAn effective seizure cluster rescue treatment, like NAYZILAM, tha= t is convenient and easily administered, along with a seizure cluster actio= n plan, can change the lives of people living with seizure clusters and the= ir families.=E2=80=9D=C2=A0 The approval of NAYZILAM was based on a placebo-controlled trial, with a pr= imary efficacy endpoint of treatment success, defined by 2 components: 1) s= eizure termination within 10 minutes and 2) no seizure recurrence within 6 = hours.^1=C2=A0NAYZILAM helped the majority of patients stop a seizure clust= er fast and helped patients return to baseline function in approximately 90= minutes.^1,13 The most common adverse reactions (=E2=89=A55% in any NAYZIL= AM treatment group) were somnolence, headache, nasal discomfort, throat irr= itation, and rhinorrhea.^1 =C2=A0Midazolam is associated with a high incide= nce of partial or complete impairment of recall for the next several hours.= ^1 UCB is committed to finding solutions for patients with unmet needs, includ= ing people living with seizure clusters. NAYZILAM builds on UCB=E2=80=99s l= ong-standing leadership in epilepsy and commitment to enabling patients to = live their best lives.=C2=A0 It is anticipated that NAYZILAM prescriptions will cost commercial patients= $40 per box.^13 Each box contains two doses.^1 With the NAYZILAM Savings C= ard, eligible patients could pay $20 per box.^13=C2=A0 For additional medical information about NAYZILAM, patient assistance, or a= ny other information please visit NAYZILAM.com or call ucbCARES^=C2=AE at 1= -844-599-2273. Full affordability information can be found at UCBUSA.news/A= ffordability.=C2=A0 UCB acquired NAYZILAM from Proximagen LLC in June 2018. About NAYZILAM^1 NAYZILAM^=C2=AE (midazolam) nasal spray CIV is a benzodiazepine indicated f= or the acute treatment of intermittent, stereotypic episodes of frequent se= izure activity (i.e., seizure clusters, acute repetitive seizures) that are= distinct from a patient=E2=80=99s usual seizure pattern in patients with e= pilepsy 12 years of age and older. The effectiveness of NAYZILAM was established in a randomized, double-blind= , placebo-controlled trial (Study 1; NCT01390220). Study 1 enrolled patients with epilepsy on a stable regimen of antiepilepti= c drugs who were identified by their physicians as having intermittent, ste= reotypic episodes of frequent seizure activity that were distinct from the = patient=E2=80=99s usual seizure pattern.=C2=A0 =C2=A0 Study 1 was conducted in two phases: an open-label Test Dose Phase followed= by a randomized, double-blind, placebo-controlled, Comparative Phase. In t= he Test Dose Phase, tolerability was assessed in 292 patients who, in the a= bsence of a seizure, received two 5 mg doses of NAYZILAM (10 mg total dosag= e) separated by 10 minutes. Patients were excluded from participation in th= e Comparative Phase if they failed to meet pre-defined blood pressure, hear= t rate, sedation, electrocardiogram, and peripheral oxygen saturation crite= ria. =C2=A0 In the Comparative Phase, 201 patients treated a single seizure cluster epi= sode in an outpatient setting with either a blinded dose of NAYZILAM 5 mg (= 134 patients) or placebo (67 patients). If the seizure activity persisted o= r 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 a= fter administration of the initial blinded dose of study drug.=C2=A0 =C2=A0 The primary efficacy endpoint for Study 1 was treatment success, defined as= the termination of seizures within 10 minutes after the initial blinded do= se of study drug and the absence of a recurrence of seizures within 6 hours= of the initial blinded dose of study drug. A statistically significantly h= igher percentage of NAYZILAM-treated patients met the primary efficacy endp= oint=C2=A0(53.7 versus 34.3%; p=3D0.011). Numerical differences in favor of NAYZILAM were observed on each of the com= ponents of the treatment success responder definition; termination of seizu= re(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 afte= r the initial dose of study drug (58.2 versus 37.3%). The most common adver= se reactions (=E2=89=A55% in any NAYZILAM treatment group) were somnolence,= headache, nasal discomfort, throat irritation, and rhinorrhea. =C2=A0 Study 1 also evaluated the occurrence and time to next seizure after the in= itial blinded dose of study drug. A smaller proportion of NAYZILAM-treated = patients experienced the next seizure within 24 hours after the initial bli= nded dose of study drug (37.3% versus 46.3%). NAYZILAM-treated patients exp= erienced a statistically longer time-to-next-seizure than the placebo group= .=C2=A0=C2=A0 For all seizure clusters treated with NAYZILAM, the median time to return t= o full baseline functionality after trial drug administration was approxima= tely 90 minutes.13 Patients=E2=80=99 return to baseline functionality was e= valuated by recording the time when the subject was able to return to what = he/she was doing prior to having a seizure cluster.13,14 Midazolam is assoc= iated with a high incidence of partial or complete impairment of recall for= the next several hours. *Eligibility Criteria and Terms: The savings card is not valid for use by p= atients who are covered by any federal or state-funded healthcare program (= including, but not limited to, Medicare [Part D and Medigap] and those who = are Medicare-eligible and enrolled in an employer-sponsored health plan for= retirees, Medicaid, any state pharmaceutical assistance program, TRICARE, = VA, or DoD), or for cash-paying patients. A valid NAYZILAM prescription con= sistent with the approved FDA labeling is required. Other Eligibility Crite= ria and Terms apply. Full Eligibility Criteria and Terms are available at w= ww.Nayzilam.com/Savings (https://u7061146.ct.sendgrid.net/wf/click?upn=3DG6= 2jSYfZdO-2F12d8lSllQB3TPzMX-2Bi53OyERb5LEmf1puI2f-2Blpvc24lM6-2BVVj1r5_-2B-= 2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rB= LYSOuAKeTefElHQ9EZfLoWbvi8z1TsACe2NM5v3jMK267vkr9TRVKV-2BE90z31tHMhDimwQyJU= zr3TP-2FFVBZrSq3-2F5xjn6pvWMbNV68KhQ7IEPq43Tr1M9tAprllEdX4nT7jfBYPqMd2K8QAh= -2BFz42xndcGDJdIjAKGpPjZfHHTR8AFZjJ1UzjHSRFp08XwA6Sv0fpeYKGbN-2Btd8gbbVujLn= jayTslT3MlY52Jrp8G5GpAxASdSR-2FKO-2BO6dmaUc9D-2FnZMIUnMic-2F0Hp-2FfoHBTIRY-= 2BoX0S4diw-3D available upon request by calling ucbCARES^=C2=AE at 1-844-59= 9-2273. =C2=A0 About Epilepsy^15-18 Epilepsy is a chronic neurological disorder of the brain. It is the fourth = most common neurological condition worldwide and affects approximately 65 m= illion people. In the U.S. more than 3.4 million people have epilepsy. Anyo= ne 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 seizur= es. Around one third of patients with epilepsy currently live with uncontro= lled seizures. =C2=A0 About Seizure Clusters Among the one third of patients living with uncontrolled epilepsy, it is es= timated that more than 150,000 of these patients in the U.S. experience sei= zure clusters.^2-4=C2=A0Seizure clusters are broadly defined as acute episo= des of consecutive seizures that occur within a short period of time when a= patient recovers during the interictal period.^[5,19] These clusters are a= lso distinguishable from a person=E2=80=99s typical seizure pattern.^5 Othe= r names for seizure clusters include acute-repetitive seizures (ARS), seria= l seizures, crescendo seizures, and seizure flurries, which highlight the r= epetitive nature of the seizures.^20=C2=A0Seizure clusters are a form of se= izure emergency that can evolve into status epilepticus.^5 =C2=A0 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 understan= ding of epilepsy and its treatment. We partner and create super-networks wi= th world-leading scientists and clinicians in academic institutions, pharma= ceutical companies, and other organizations who share our goals. At UCB, we= are inspired by patients, and driven by science in our commitment to suppo= rt patients with epilepsy. Important Safety Information for NAYZILAM^1 NAYZILAM is indicated for the acute treatment of intermittent, stereotypic = episodes of frequent seizure activity (i.e., seizure clusters, acute repeti= tive seizures) that are distinct from a patient=E2=80=99s usual seizure pat= tern in patients with epilepsy 12 years of age and older. =C2=A0 CONTRAINDICATIONS NAYZILAM is contraindicated in patients with acute narrow-angle glaucoma. =C2=A0 RISKS FROM CONCOMITANT USE WITH OPIOIDS =C2=B7 Concomitant use of benzodiazepines, including NAYZILAM, and opioids may res= ult in profound sedation, respiratory depression, coma, and death.=C2=A0 =C2=B7 Reserve concomitant prescribing of these drugs for use in patients for whom= alternative treatment options are inadequate. =C2=B7 Limit dosages and durations to the minimum required. =C2=B7 Follow patients for signs and symptoms of respiratory depression and sedati= on. RISKS OF CARDIORESPIRATORY ADVERSE REACTIONS Serious cardiorespiratory adverse reactions have occurred after administrat= ion of midazolam. Warn patients and caregivers about the risks of respirato= ry depression, cardiac and respiratory arrest. =C2=A0 Respiratory depression was observed with the administration of NAYZILAM dur= ing clinical trials. Cardiac or respiratory arrest caused by NAYZILAM was n= ot reported during clinical trials. =C2=A0 CENTRAL NERVOUS SYSTEM DEPRESSION FROM CONCOMITANT USE WITH OTHER CENTRAL N= ERVOUS SYSTEM DEPRESSANTS, OR MODERATE OR STRONG CYP3A4 INHIBITORS Drug products containing midazolam, including NAYZILAM, have a central nerv= ous system (CNS) depressant effect.=C2=A0 =C2=A0 Risks from Concomitant Use with Other CNS Depressants NAYZILAM may cause an increased CNS-depressant effect when used with alcoho= l or other CNS depressants (e.g., opioids). Warn patients and caregivers th= at the use of NAYZILAM in combination with alcohol or other CNS depressant = drugs may increase the risk of hypoventilation, airway obstruction, desatur= ation, or apnea and may contribute to profound and/or prolonged drug effect. =C2=A0 Risks from Concomitant Use with Moderate or Strong CYP3A4 Inhibitors Concomitant use of NAYZILAM with moderate or strong CYP3A4 enzyme inhibitor= s may result in prolonged sedation because of a decrease in plasma clearanc= e of midazolam. Caution patients against engaging in hazardous occupations = requiring mental alertness, such as operating machinery, driving a motor ve= hicle or riding a bicycle until they have completely returned to their leve= l of baseline functioning. =C2=A0 SUICIDAL BEHAVIOR AND IDEATION Antiepileptic drugs (AEDs), including NAYZILAM, increase the risk of suicid= al thoughts or behavior in patients taking these drugs for any indication. = Monitor patients treated with NAYZILAM for the emergence or worsening of de= pression, suicidal thoughts or behavior, and/or any unusual changes in mood= or behavior. Advise patients and caregivers to be alert for these behavior= al changes and to immediately report them to the healthcare provider. =C2=A0 IMPAIRED COGNITIVE FUNCTION Midazolam, including NAYZILAM, is associated with a high incidence of parti= al or complete impairment of recall for several hours following an administ= ered dose. Counsel patients on when they can engage in activities requiring= complete mental alertness, operate hazardous machinery, or drive a motor v= ehicle after taking NAYZILAM. =C2=A0 GLAUCOMA Benzodiazepines, including NAYZILAM, can increase intraocular pressure in p= atients with glaucoma. NAYZILAM may be used in patients with open-angle gla= ucoma only if they are receiving appropriate therapy. NAYZILAM is contraind= icated in patients with narrow-angle glaucoma. =C2=A0 ADVERSE REACTIONS In the randomized, double-blind, placebo-controlled trial, the most common = adverse reactions (=E2=89=A55% in any NAYZILAM treatment group) were somnol= ence, headache, nasal discomfort, throat irritation, and rhinorrhea. =C2=A0 NAYZILAM is a Schedule IV controlled substance. =C2=A0 Please refer to the full Prescribing Information at www.UCB-USA.com.=C2=A0 = (https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQB13L= 1-2FEHVunnJvWTK7OpcrgltwNxhoCKurBduUbGDgJM_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8Rp= J4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1= TsACe2NM5v3jMK267vkr9TRVKV-2BE90z31tHMhDimwQyJUzr3TP-2FFVBZrSq3-2F5xjn6pvWM= bNV68KhQ7IEPq43Tr1M9tAprllEdX4nT7jfBYPqMd7OgelvdOU2dSbCpNG-2B-2BlrW5hx8d3yt= XxYsVt2g4XtjY3xS9k9YC07PGh8QdCBME0SoiAcNure08DAPF7Phjtl21z4HKeFoJLUsnFKRGjF= 8SXrBKM4SgvtYlO2ROxFHLpQPC3djRy5aZXW0JdD3k62k-3D =C2=A0 For additional medical information about NAYZILAM, patient assistance, or a= ny other information please visit our website or call ucbCARES at 1-844-599= -2273. =C2=A0 ### =C2=A0 NAYZILAM^=C2=AE and ucbCARES^=C2=AE are registered trademarks of the UCB Gr= oup of Companies. =C2=A92019 UCB, Inc., Smyrna, GA 30080. All rights reserved. =C2=A0 For further information, UCB: U.S. Communications Erica Puntel=C2=A0=C2=A0 =C2=A0 Communications, U.S.=C2=A0 T. 404.938.5359 =C2=A0 Brand Communications Jim Baxter=C2=A0 Neurology Communications, UCB T+32.2.473.78.85.01 jim.baxter@ucb.com=C2=A0 =C2=A0 Investor Relations Antje Witte=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0 Investor Relations, UCB T +32.2.559.94.14 antje.witte@ucb.com =C2=A0 Isabelle Ghellynck, Investor Relations, UCB T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0 =C2=A0 About UCB UCB, Brussels, Belgium (www.ucb.com (https://u7061146.ct.sendgrid.net/wf/cl= ick?upn=3DG62jSYfZdO-2F12d8lSllQBw0oh-2B0jU5L7x-2BtFd3jcAPw-3D_-2B-2Ft0TnE1= oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKe= TefElHQ9EZfLoWbvi8z1TsACe2NM5v3jMK267vkr9TRVKV-2BE90z31tHMhDimwQyJUzr3TP-2F= FVBZrSq3-2F5xjn6pvWMbNV68KhQ7IEPq43Tr1M9tAprllEdX4nT7jfBYPqMd8UTWsv-2FZiza5= ucflkxTqGcF-2FrbEdbTvdvyPiPygq3edkeknTk2LVmNxbKQ0mjUn76W-2Ff4lFUnnAmYHQzXzp= 76taAAykwNRjWasPlFxHwdsXGvPLTX3mUs76xK6eJ6Ni9du2FtbY1589xoBcjAbQF-2F0-3D ) = is a global biopharmaceutical company focused on the discovery and developm= ent of innovative medicines and solutions to transform the lives of people = living with severe diseases in immunology or neurology. With around 7 500 p= eople, operating in 40 countries, the company generated revenue of =E2=82= =AC 4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). = Follow us on Twitter: @UCBUSA (https://u7061146.ct.sendgrid.net/wf/click?up= n=3DG62jSYfZdO-2F12d8lSllQBxDfFLNPVU-2Fq1y44E3KN7CZqsbmJ8wve8VrfwmQpmItH_-2= B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7= rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsACe2NM5v3jMK267vkr9TRVKV-2BE90z31tHMhDimwQy= JUzr3TP-2FFVBZrSq3-2F5xjn6pvWMbNV68KhQ7IEPq43Tr1M9tAprllEdX4nT7jfBYPqMdyosz= wJF0F8RbyZNt284FrqaB-2B1GMzV9qm-2BZgS-2BF841RZoxmVPkElD9W15UpdijHLVXjq07H00= klPdJuod3hpxI6zlwNeVVrBSioCM3dpzY7MGaeDBjYWtjmsvkqwHYt7kvkHCA7KqywMCM7SlYUo= Ic-3D =C2=A0 Forward looking statements=C2=A0 This press release contains forward-looking statements based on current pla= ns, estimates and beliefs of management. All statements, other than stateme= nts of historical fact, are statements that could be deemed forward-looking= statements, including estimates of revenues, operating margins, capital ex= penditures, cash, other financial information, expected legal, political, r= egulatory or clinical results and other such estimates and results. By thei= r nature, such forward-looking statements are not guarantees of future perf= ormance and are subject to risks, uncertainties and assumptions which could= cause actual results to differ materially from those that may be implied b= y such forward-looking statements contained in this press release. Importan= t factors that could result in such differences include: changes in general= economic, business and competitive conditions, the inability to obtain nec= essary regulatory approvals or to obtain them on acceptable terms, costs as= sociated with research and development, changes in the prospects for produc= ts in the pipeline or under development by UCB, effects of future judicial = decisions or governmental investigations, product liability claims, challen= ges to patent protection for products or product candidates, changes in law= s or regulations, exchange rate fluctuations, changes or uncertainties in t= ax laws or the administration of such laws and hiring and retention of its = employees.=C2=A0 =C2=A0 Additionally, information contained in this document shall not constitute a= n 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 jurisdi= ction in which such offer, solicitation or sale would be unlawful prior to = the registration or qualification under the securities laws of such jurisdi= ction. UCB is providing this information as of the date of this document an= d expressly disclaims any duty to update any information contained in this = press release, either to confirm the actual results or to report a change i= n its expectations. =C2=A0 There is no guarantee that new product candidates in the pipeline will prog= ress to product approval or that new indications for existing products will= be developed and approved. Products or potential products which are the su= bject of partnerships, joint ventures or licensing collaborations may be su= bject to differences between the partners. Also, UCB or others could discov= er safety, side effects or manufacturing problems with its products after t= hey are marketed. =C2=A0 Moreover, sales may be impacted by international and domestic trends toward= managed care and health care cost containment and the reimbursement polici= es imposed by third-party payers as well as legislation affecting biopharma= ceutical pricing and reimbursement. =C2=A0 References:=C2=A0 1. NAYZILAM^=C2=AE (midazolam) nasal spray CIV. US Prescribing Information.= =C2=A0 2. Zack M, R Kobau. National and State Estimates of the Numbers of Adults a= nd Children with Active Epilepsy. CDC MMWR. 2017. 66:821-825. 3. Kwan P, M Brodie. Early Identification of Refractory Epilepsy. NEJM. 200= 5. 342:314-319. 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, et al. Burden of seizure clusters on p= atients with epilepsy and caregivers survey of patient, caregiver, and clin= ician perspectives. The Neurologist. 2017;22:207=E2=80=93214. 6. Haut S. Seizure clusters: characteristics and treatment. Current Opinion= Neurology. 28:143=E2=80=93150, 2015. 7. Buck D, et al. Patients' Experiences of Injury as a Result of Epilepsy. = Epilepsia. 38(4):439-444, 1997. 8. Cereghino JJ, Mitchell WG, Murphy J, et al. Treating repetitive seizures= with a rectal diazepam formulation: a randomized study. The North American= Diastat Study Group. Neurology. 1998;51(5):1274-1282. 9. Holsti M, Dudley N, Schunk J, et al. Intranasal midazolam vs rectal diaz= epam for the home treatment of acute seizures in pediatric patients with ep= ilepsy. Arch Pediatr Adolesc Med. 2010;164(8):747-753. 10. de Haan GJ, van der Geest P, Doelman G, Bertram E, Edelbroek P. A compa= rison of midazolam nasal spray and diazepam rectal solution for the residen= tial treatment of seizure exacerbations. Epilepsia. 2010;51(3):478-482 11. Nunley S, Glynn P, Rust S, Vidaurre J, Albert DVF, Patel AD. A hospital= -based study on caregiver preferences on acute seizure rescue medications i= n pediatric patients with epilepsy: intranasal midazolam versus rectal diaz= epam. Epilepsy Behav. 2019;92:53-56. 12. Bhattacharyya M, Kalra V, Gulati S. Intranasal midazolam vs rectal diaz= epam in acute childhood seizures. Pediatr Neurol. 2006;34(5):355-359. 13. Data on File, UCB Inc. 14. Detyniecki K, Van Ess P, Sequeira D, Wheless J, Meng T, Pullman W. Safe= ty and efficacy of midazolam nasal spray in the outpatient treatment of pat= ients with seizure clusters =E2=80=93 a randomized, double-blind, placebo-c= ontrolled trial. Epilepsia. 2019;60; 1797-1808. 15. Centers for Disease Control and Prevention. Available at https://u70611= 46.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQB65TMnPO9n6B7XhPnsE= OguZa4t1pOAIYrVJh6SD2yt3OFtBS9WKfyLQ6puCl7npehg-3D-3D_-2B-2Ft0TnE1oEbVIWS8v= HM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9E= ZfLoWbvi8z1TsACe2NM5v3jMK267vkr9TRVKV-2BE90z31tHMhDimwQyJUzr3TP-2FFVBZrSq3-= 2F5xjn6pvWMbNV68KhQ7IEPq43Tr1M9tAprllEdX4nT7jfBYPqMd3R-2FNs714kDy8-2FxxTn5w= 0V9Gaaq0n-2BGk48TNE4Qmexm61ylrkC-2BiIzGD3e6c6kS5n2trpg-2Bsw3ViKkyp2hnDKB49K= K7gQ7clO0-2Fx7ShE55IZ1CqY8gMw4bf3mLJgn3gT5qbD9YZ6EsD8ljfwBT87FCo-3D Accesse= d 22 November 2019.=C2=A0 16. The Epilepsy Foundation of America. About epilepsy basics. https://u706= 1146.ct.sendgrid.net/wf/click?upn=3D84Em28S1K9SvtzcUtu04ErLUM6iZpi3ULUyIca6= M9-2BgMJ-2FYP7tFxa00hrvdBl9M3POQagm9NzPvzYlvHsBfd8g-3D-3D_-2B-2Ft0TnE1oEbVI= WS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefEl= HQ9EZfLoWbvi8z1TsACe2NM5v3jMK267vkr9TRVKV-2BE90z31tHMhDimwQyJUzr3TP-2FFVBZr= Sq3-2F5xjn6pvWMbNV68KhQ7IEPq43Tr1M9tAprllEdX4nT7jfBYPqMd-2FU0zlRCFI-2BC-2BJ= dREKssD3pYorV64WFpCjPjmv6mdQc2cOYybVNMC7LXjpjnvZxX8U0x8DF010osBThPoqI6xYUYt= d6tbZEOCvLY6Fc3uh3I7ZVZcfUFHexim1GeDhtGYuoqhBh0wR9kBZRgqEkSn6w-3D Accessed = 22 November 2019.=C2=A0 17. The Epilepsy Foundation of America. What is epilepsy? https://u7061146.= ct.sendgrid.net/wf/click?upn=3D84Em28S1K9SvtzcUtu04ErLUM6iZpi3ULUyIca6M9-2B= hN8HXuNcyhsxil2R3vsSKfRxkOil65WrEv6TrxKg2QskgQFTnGA-2B-2FdNnVWQ1vUWwE-3D_-2= B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7= rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsACe2NM5v3jMK267vkr9TRVKV-2BE90z31tHMhDimwQy= JUzr3TP-2FFVBZrSq3-2F5xjn6pvWMbNV68KhQ7IEPq43Tr1M9tAprllEdX4nT7jfBYPqMdxTqX= iG48MGksaOQ9JL5KCAktmOICGBa8Co7WsZH4I0dUCFrivvyJN-2FyI0NfGBlmvkgUBA8YrtRVKZ= T7Yis589GMClUV0J7uajVTR6HNqd4ziWBwEDVsvIWJHk8STFzW-2FzVSNkuWha6GvePsscyc-2B= 1o-3D Accessed 22 November 2019.=C2=A0 18. The Epilepsy Foundation of America. Who gets epilepsy? https://u7061146= .ct.sendgrid.net/wf/click?upn=3D84Em28S1K9SvtzcUtu04ErLUM6iZpi3ULUyIca6M9-2= BhN8HXuNcyhsxil2R3vsSKfb3RQuK5bJTAPNddME3gYq9gwttBx-2BJBmkJzY5TnhPww-3D_-2B= -2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7r= BLYSOuAKeTefElHQ9EZfLoWbvi8z1TsACe2NM5v3jMK267vkr9TRVKV-2BE90z31tHMhDimwQyJ= Uzr3TP-2FFVBZrSq3-2F5xjn6pvWMbNV68KhQ7IEPq43Tr1M9tAprllEdX4nT7jfBYPqMd8P9CY= G2LXTXOUMySZda1CcHqqTP4Ru9LZXTwk3B2VlEXIcCBQ37JGsuBlHbQkS4l1KvS5X4KofQsGYNV= SYeRf-2BG5ctCkM-2FETtlp71sZdvy30IVsTaVWdwVxnRItKzCKmR45Yn30Y8q1f3cn7nd1OLg-= 3D Accessed 22 November 2019 19. The Epilepsy Foundation of America. Seizure Clusters. https://u7061146.= ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQBzptYYHHq6Vxey35nE9gfv= oNb47pENIqXBOY3BSJZxOTO5tADeVVcXwJrPGi3YP5Ujp2gdi9AJY2UZPm6s-2FFiHrKqATUCpP= gcOZptLaEl-2BEZ_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTj= zwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsACe2NM5v3jMK267vkr9TRVKV-= 2BE90z31tHMhDimwQyJUzr3TP-2FFVBZrSq3-2F5xjn6pvWMbNV68KhQ7IEPq43Tr1M9tAprllE= dX4nT7jfBYPqMd6b3-2FmPCCevX1HPAEAU8NUDh-2ByzgfCqmt-2BHc-2BQ8dah99yNneWdo-2B= zMhEeXHXoKEGJTD7fY484nLR1AUylXrtiiFvg3RZMwTjoaFg1Hqv7oe5Ai5yfw36Gf6Stb8MG8q= qdBIDe-2B2nWfdbV8WS-2BmUO0Vk-3D Accessed 22 November 2019. 20. Jafarpour S, Hirsch LJ, Ga=C3=ADnza-Leina M, et al. Seizure cluster: De= finition, prevalence, consequences, and management. Seizure. 68:9-15.2019.= =0D =0D ______________________=0D If you would rather not receive future communications from UCB SA, please g= o to https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQ= Bz2p53T0v-2BoEIvbo6vDi8C-2BOyFzyb6obo-2BzKSgNKq4mr8mC4XxNlte3gMWy7x6wXJY-2F= fmWFvjUcYVgEIhYUcrcRIyQmviGCSzHNWHKi2l2OUY8JF3SR3IhGlviuJBnUErukFBljN2jMpLx= 8FnX9Omo0-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwc= PKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsACe2NM5v3jMK267vkr9TRVKV-2BE= 90z31tHMhDimwQyJUzr3TP-2FFVBZrSq3-2F5xjn6pvWMbNV68KhQ7IEPq43Tr1M9tAprllEdX4= nT7jfBYPqMd4H-2BKBNLlwntTDsdL-2FspM7MbZUlN8wOKL8fIM9N8Q2thNya08W-2FDgCatN6-= 2BmPQTx0Y8V-2FAVpcL7ePZn7ypFR2JjIHlEJmY3FjdL3b2VeDdz9-2FRevS4C4QPMKOcCKYorq= Vvju07ZRCI-2BKOUcRa-2FK3EqA-3D=0D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium=

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