Stiripentol

Results of a social media listening study of women of childbearing age with epilepsy underscore the need for HCPs to provide relevant information at critical time points to support shared decision-making2 A quality-of-life survey administered to caregivers of individuals with developmental and epileptic encephalopathies (DEEs) suggests improved understanding of caregiver definitions of normal and disruptive experiences can help researchers prioritize areas of focus to improve outcomes3 Study shows prolonged seizures are a key driver in worsening quality of life for people with epilepsy and their caregivers4 Pharmacokinetic data from Phase 1 study shows alprazolam administration via the Staccato® hand-held device is an efficient delivery route currently being studied for stereotypical prolonged seizures5 New efficacy data on FINTEPLA® (fenfluramine) as a treatment for seizures associated with Lennox-Gastaut syndrome (LGS)6 ATLANTA, Dec. 6, 2024 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced data being presented at the American Epilepsy Society (AES) Annual Meeting, taking place December 6–10 in Los Angeles, California, that focus on the impact and burden of epilepsy on people living with epilepsy and their caregivers. FINTEPLA® (fenfluramine) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients two years of age and older. (PRNewsfoto/UCB) Key data being presented show women of childbearing age (WoCBA) with epilepsy face challenges in gaining access to relevant information related to their treatment at the right time and stage in their motherhood journey.2 Often, relevant information is conflicting, not provided or easy to obtain, and questions related to epilepsy and pregnancy remain unanswered, leading to confusion and heightened anxiety.2 "At UCB, we recognize that when we listen to people living with and caring for those with epilepsy and rare syndromes and give them the opportunity to share their stories, we are better able to understand and address their range of unique needs. The robust data presented at AES demonstrate our commitment to symptom management as well as holistic patient care," said Brad Chapman, Head of U.S. Epilepsy and Rare Syndromes, UCB. "Specifically for women of childbearing age, having the right information about epilepsy is not just about managing seizures—it's about working together to encourage open communication about epilepsy, providing access to trusted resources, and empowering the community with knowledge so they can make more confident decisions about their personal care journey." In other data presented, the impact and associated burden of prolonged seizures (PS) have been found to have a profound effect on the mental health of people living with epilepsy and their caregivers, including anxiety and/or depression, reinforcing the need to bring more holistic solutions to patients and their caregivers.4 "Prolonged seizures can significantly worsen both the physical and emotional well-being of people living with epilepsy and their caretakers, underscoring the critical need for timely, effective treatment. We are excited to present new data at AES on Staccato alprazolam, an investigational drug under study in a phase 3 trial for prolonged seizures," said Hugo Xi, Head of Medical Neurology, UCB. Presentation on WoCBA with Epilepsy Going Through Motherhood: Experiences of Women of Childbearing Age with Epilepsy Throughout their Motherhood Journey and Results from a Social Media Listening Study A social media listening study was conducted across six countries (U.S., UK, France, Germany, Spain and Italy) to characterize the issues and unmet needs of WoCBA (ages 15-49) with epilepsy related to their motherhood journey. Nearly 250,000 posts on social media accounts (X, forums, YouTube, blogs, Instagram and Facebook) were analyzed over a 12-month period.2 Study results, presented in a poster session, found that WoCBA with epilepsy want to be empowered through knowledge and feel they need support finding comprehensive information at the right time in their motherhood journey to increase their confidence in shared decision-making.2 However, relevant information often is not provided or easy to obtain, and these women experience confusion and heightened anxiety because they are given conflicting guidance, and their questions related to epilepsy, contraception, pregnancy, and parenthood remain unanswered.2 Presentation on Impact of Prolonged Seizures on Patients' and Caregivers' Quality of Life Interviews and focus groups were conducted with U.S.-based adults aged 18 or older with epilepsy and caregivers of people with epilepsy age 12 or older to identify unmet needs, determine the greatest areas of burden, and assess the impact on QoL of PS, which typically last 2 or more minutes and usually do not stop on their own or worsen over time.4 Study results, presented in a poster session, found that 71% of participants reported that they or their loved ones were currently experiencing PS. 4 Living with PS has a profound effect on the mental health of people with epilepsy and their caregivers.4 Among participants, 74% experienced anxiety and/or depression, and 60% reported receiving medication or seeking therapy to help manage their mental health.4 Given this negative impact on QoL, there is an opportunity to encourage discussion and build resources for social, emotional, and psychological support for individuals experiencing PS and their caregivers.4 Presentation on Inhalation as an Efficient Delivery Route of Alprazolam for the Treatment of Acute Seizures: Randomized Study of Staccato® Alprazolam Relative to Oral Alprazolam An analysis of data from a Phase 1 study of Staccato alprazolam compared the plasma concentration of alprazolam following administration via inhalation with the Staccato device with that of alprazolam administered orally.5 Staccato alprazolam, an investigational drug in Phase 3 clinical development, is designed to be used as a single-use epileptic seizure rescue therapy that combines the Staccato delivery technology with alprazolam, a benzodiazepine.5 Staccato® alprazolam is a hand-held device that can provide rapid systemic delivery of alprazolam via inhalation, with the potential to provide rapid and early seizure termination.5 Presentation On Disruptive Impacts Of Developmental And Epileptic Encephalopathies On Patient And Family Life: A Quality-Of-Life Survey An internet-based DEE survey to define "normal" and "disruptive" symptoms by understanding how 5 key domains (seizures, sleep, communication, behavior and activities of daily living [ADLs]) affect the individual and their family members, developed in consultation with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) patient communities via patient advocacy websites, social media, and patient community events, was presented as a late-breaking abstract.3 A majority of the 489 caregivers reported that the patients with DEE experienced disruptive seizures, sleep or behavior, with these disruptive symptoms leading to temporary loss of communication and/or at least one activity of daily living (ADL).3 Presentation on FINTEPLA® ( fenfluramine) Efficacy Trajectories in Placebo or Treatment Groups From Randomized Controlled Trial to Open-Label Extension A phase 3 randomized study of FINTEPLA (fenfluramine) for management of seizures associated with Lennox-Gastaut syndrome (LGS) was presented as a podium presentation.6 Results showed that patients previously randomized to placebo in the randomized controlled trial (RCT) exhibited improvements in efficacy outcomes following transition to FINTEPLA in the open-label extension (OLE).6 The change in frequency of seizures associated with a fall occurred during month 1 of the OLE indicating a rapid onset of efficacy.6 Improvements were similarly noted in responder rates for seizures associated with a fall and clinical global impression – improvement (CGI-I) scale.6 About Staccato® Alprazolam Staccato® alprazolam is an investigational treatment (Phase 3) currently being studied to assess its potential to rapidly terminate seizures at risk of becoming prolonged or progressing to a more severe seizure type. The ability to stop a seizure as it is starting is an unmet need for epilepsy management today in the outpatient setting.7 This portable treatment combines the Staccato® delivery technology with alprazolam, a benzodiazepine, in a single inhaled dose. *The safety and efficacy of Staccato® alprazolam have not been established, and it is not currently approved for use in this indication by any regulatory authority worldwide. About Epilepsy Epilepsy is a common neurological condition worldwide and affects approximately 50 million people. Epilepsy can develop in any person at any age and is usually diagnosed after a person has had at least two seizures (or after one seizure with a high risk for more) that were not caused by some known medical condition. About UCB in Epilepsy For three decades we've been committed to people living with epilepsy and their families, surrounding the patient and caregiver through every step of their care journey. At our core we have a responsibility to elevate the healthcare ecosystem. Because of this, we have established our legitimacy on the front lines of epilepsy research, development, and treatment innovation. But our past breakthroughs are only a prologue to our future. We will continue to reimagine how we care for patients, leveraging today's expertise for a better tomorrow. With so much experience behind us and so much potential ahead, we are more invested than ever in profoundly improving the lives of those living with or caring for those with epilepsy or a rare epilepsy syndrome – through our relentless pursuit of a seizure-free life. About FINTEPLA® (fenfluramine) Oral Solution1 FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older. FINTEPLA is available only through a restricted distribution program called the FINTEPLA REMS. Further information is available at or by telephone at +1 877 964 3649. IMPORTANT SAFETY INFORMATION BOXED WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension. Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. FINTEPLA is available only through a restricted program called the FINTEPLA REMS. CONTRAINDICATIONS FINTEPLA is contraindicated in patients with hypersensitivity to fenfluramine or any of the excipients in FINTEPLA and with concomitant use, or within 14 days of the administration, of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome. WARNINGS AND PRECAUTIONS Valvular Heart Disease and Pulmonary Arterial Hypertension (see Boxed Warning): Because of the association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease (VHD) and pulmonary arterial hypertension (PAH), cardiac monitoring via echocardiogram is required prior to starting treatment, during treatment, and after treatment with FINTEPLA concludes. Cardiac monitoring via echocardiogram can aid in early detection of these conditions. In clinical trials for DS and LGS of up to 3 years in duration, no patient receiving FINTEPLA developed VHD or PAH. Monitoring: Prior to starting treatment, patients must undergo an echocardiogram to evaluate for VHD and PAH. Echocardiograms should be repeated every 6 months, and once at 3-6 months post treatment with FINTEPLA. The prescriber must consider the benefits versus the risks of initiating or continuing treatment with FINTEPLA if any of the following signs are observed via echocardiogram: valvular abnormality or new abnormality; VHD indicated by mild or greater aortic regurgitation or moderate or greater mitral regurgitation, with additional characteristics of VHD (eg, valve thickening or restrictive valve motion); PAH indicated by elevated right heart/pulmonary artery pressure (PASP >35 mmHg). FINTEPLA REMS Program (see Boxed Warning): FINTEPLA is available only through a restricted distribution program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified by enrolling in the FINTEPLA REMS. Prescribers must counsel patients receiving FINTEPLA about the risk of VHD and PAH, how to recognize signs and symptoms of VHD and PAH, the need for baseline (pretreatment) and periodic cardiac monitoring via echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment. Patients must enroll in the FINTEPLA REMS and comply with ongoing monitoring requirements. The pharmacy must be certified by enrolling in the FINTEPLA REMS and must only dispense to patients who are authorized to receive FINTEPLA. Wholesalers and distributors must only distribute to certified pharmacies. Further information is available at or by telephone at 1-877-964-3649. Decreased Appetite and Decreased Weight: FINTEPLA can cause decreases in appetite and weight. Decreases in weight appear to be dose related. Approximately half of the patients with LGS and most patients with DS resumed the expected measured increases in weight during the open-label extension studies. Weight should be monitored regularly during treatment with FINTEPLA, and dose modifications should be considered if a decrease in weight is observed. Somnolence, Sedation, and Lethargy: FINTEPLA can cause somnolence, sedation, and lethargy. Other central nervous system (CNS) depressants, including alcohol, could potentiate these effects of FINTEPLA. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA to gauge whether it adversely affects their ability to drive or operate machinery. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including FINTEPLA, increase the risk of suicidal thoughts or behaviors in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behavior. Anyone considering prescribing FINTEPLA or any other AED must balance the risk of suicidal thoughts or behaviors with the risks of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behaviors. Should suicidal thoughts and behaviors emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Withdrawal of Antiepileptic Drugs: As with most AEDs, FINTEPLA should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered. Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening condition, may occur with FINTEPLA, particularly during concomitant administration of FINTEPLA with other serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (eg, St. John's Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA), dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the emergence of signs and symptoms of serotonin syndrome, which include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started. Increase in Blood Pressure: FINTEPLA can cause an increase in blood pressure. Rare cases of significant elevation in blood pressure, including hypertensive crisis, has been reported in adult patients treated with fenfluramine, including patients without a history of hypertension. In clinical trials for DS and LGS of up to 3 years in duration, no pediatric or adult patient receiving FINTEPLA developed hypertensive crisis. Monitor blood pressure in patients treated with FINTEPLA. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Consider discontinuing treatment with FINTEPLA in patients with acute decreases in visual acuity or ocular pain. ADVERSE REACTIONS The most common adverse reactions observed in DS studies (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus. The most common adverse reactions observed in the LGS study (incidence at least 10% and greater than placebo) were diarrhea; decreased appetite; fatigue; somnolence; vomiting. DRUG INTERACTIONS Strong CYP1A2, CYP2B6, or CYP3A Inducers: Coadministration with strong CYP1A2, CYP2B6, or CYP3A inducers will decrease fenfluramine plasma concentrations. If coadministration of a strong CYP1A2, CYP2B6, or CYP3A inducer with FINTEPLA is necessary, monitor the patient for reduced efficacy and consider increasing the dosage of FINTEPLA as needed. If a strong CYP1A2, CYP2B6, or CYP3A inducer is discontinued during maintenance treatment with FINTEPLA, consider gradual reduction in the FINTEPLA dosage to the dose administered prior to initiating the inducer. Strong CYP1A2 or CYP2D6 Inhibitors: Coadministration with strong CYP1A2 or CYP2D6 inhibitors will increase fenfluramine plasma concentrations. If FINTEPLA is coadministered with strong CYP1A2 or CYP2D6 inhibitors, the maximum daily dosage of FINTEPLA is 20 mg. If a strong CYP1A2 or CYP2D6 inhibitor is discontinued during maintenance treatment with FINTEPLA, consider gradual increase in the FINTEPLA dosage to the dose recommended without CYP1A2 or CYP2D6 inhibitors. If FINTEPLA is coadministered with stiripentol and a strong CYP1A2 or CYP2D6 inhibitor, the maximum daily dosage of FINTEPLA is 17 mg. USE IN SPECIFIC POPULATIONS In patients with severe impairment of kidney function (estimated glomerular filtration rate [eGFR]) 15 to 29 mL/min/1.73m2, dosage adjustments are recommended. FINTEPLA has not been studied in patients with kidney failure (eGFR <15 mL/min/1.73m2). Combined molar exposures of fenfluramine and norfenfluramine were increased in subjects with various degrees of hepatic impairment (Child-Pugh Class A, B, and C), necessitating a dosage adjustment in these patients. To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1 844-599-2273 or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information including Boxed Warning and Medication Guide , for additional Important Safety Information on FINTEPLA. About UCB UCB, Brussels, Belgium () 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 of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA. For further information, contact UCB: Investor Relations Antje Witte T: +32.2.559.94.14 email [email protected] US Communications Becky Malone T +1.919.605.9600 Email [email protected] Forward looking statements This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. 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UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future. UCB is providing this information, including forward-looking statements, only as of the date of this press release. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. 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. REFERENCES FINTEPLA (fenfluramine) oral solution: U.S. prescribing information. Smyrna, GA: UCB, Inc. Baker GA, et al. 2024. AES. Poster number 2.284. Bailey L, et al. 2024. AES. Poster number 1.498. Kaye D, et al. 2024. AES. Poster number 1.100. Daniels T, et al. 2024. Poster number 3.404. Nabbout R, et al. 2024. AES. Poster number 1.401. Pina-Garza JE, Chez M, Cloyd J, et al. Outpatient management of prolonged seizures and seizure clusters to prevent progression to a higher-level emergency: Consensus recommendations of an expert working group. Epileptic Disord. 2024;26(4):484-497. US-DA-2401037 Date of Preparation: November 2024 FINTEPLA® is a registered trademark of the UCB Group of Companies. STACCATO® is a registered trademark of Alexza Pharmaceuticals, Inc., and is used by UCB under license. ©2024 UCB, Inc., Smyrna, GA 30080. All rights reserved. SOURCE UCB WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BEDMINSTER, N.J., Dec. 2, 2024 /PRNewswire/ -- Biocodex, a global pharmaceutical company and long-time pioneer in the treatment of rare pediatric diseases, will present seven studies at the upcoming AES 2024 Annual Meeting in Los Angeles, CA, from December 6-10. The studies focus on the use of stiripentol and its impact on patients with Dravet syndrome. Carla Schad, M.D., Biocodex North American Medical Officer, previewed what providers can expect to see from Biocodex at AES this year. Continue Reading DIACOMIT (stiripentol) is indicated for the treatment of seizures associated with Dravet syndrome in patients taking clobazam and who are 6 months of age or older and weigh 15 pounds or more. There are no clinical data to support the use of DIACOMIT alone in Dravet syndrome. "Biocodex USA is thrilled to be attending AES this year. We are dedicated to bringing new data to our health care providers and researchers; but most importantly, our AES attendance will highlight our partnerships with Thought Leaders and Advocates. At Biocodex, our commitment and promise are to always keep the patient first." Key scientific and patient-focused data include: Symposia & CME Programs at the AES 2024 Annual Meeting Biocodex will be hosting two informational symposia at this conference focusing on the following: Biocodex is also sponsoring a CME program on Saturday, December 7, 6:00 PM – 9:00 PM in the JW Marriot, Los Angeles California titled, "Mortality Risk with Dravet Syndrome: Let's Check That Box." This program will explore the importance of the following in Dravet syndrome: early diagnosis, risk factors for increased mortality, ways to improve communication with caregivers about increased mortality risk and evaluating the impact of targeted therapies on mortality risk. About Dravet Syndrome Dravet syndrome is a rare and severe genetic epilepsy that most commonly begins before the age of one when an otherwise normally developing child begins having frequent, prolonged seizures.1 These seizures can cause lasting damage, which over time can lead to developmental and cognitive delays, affecting coordination, language, and behavior.2 Its incidence is estimated to be 1 in 16,000 births.3 About Biocodex Founded in 1953, Biocodex is a French family-owned pharmaceutical company that leverages life sciences, placing health and its balance at the heart of its corporate initiatives, innovations, and development for the benefit of patients worldwide. A pioneer and leader in human microbiota health by marketing the first probiotic strain, the global organization has developed its activities around three strategic areas: microbiota, women's health, and orphan diseases. It has also expanded its expertise by investing in other health areas, such as pain management, respiratory and ENT pathways, and neurology. Present in 115 countries through its subsidiaries and partners, Biocodex emphasizes its territorial roots, which are central to its corporate social responsibility, producing in France for over 50 years across most of its value chain. The Biocodex global organization is comprised of 1,700 employees who share common values, embodied in their daily missions and rooted in the company's DNA. To learn more about Biocodex visit: To learn more about DIACOMIT visit: INDICATION DIACOMIT (stiripentol) is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS None WARNINGS & PRECAUTIONS Somnolence DIACOMIT can cause somnolence. Monitor patients for somnolence, particularly when DIACOMIT is used concomitantly with other CNS depressants or clobazam, which is also known to cause somnolence. Decreased Appetite and Decreased Weight DIACOMIT can cause decreases in appetite and weight. The growth and weight of pediatric patients treated with DIACOMIT should be carefully monitored. Neutropenia and Thrombocytopenia DIACOMIT can cause significant declines in neutrophil and platelet counts. Hematologic testing should be obtained prior to starting treatment with DIACOMIT and then every 6 months. Withdrawal Symptoms As with most antiepileptic drugs (AEDs), DIACOMIT should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus. Risks in Patients with Phenylketonuria (PKU) DIACOMIT for oral suspension contains phenylalanine, which can be harmful to patients with PKU. Before prescribing DIACOMIT for oral suspension to a patient with PKU, consider the total daily intake of phenylalanine from all sources, including DIACOMIT for oral suspension. DIACOMIT capsules do not contain phenylalanine. Suicidal Behavior and Ideation AEDs, including DIACOMIT, increase the risk of suicidal thoughts or behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. ADVERSE REACTIONS The most common adverse reactions that occurred in at least 10% of DIACOMIT-treated patients and more frequently than on placebo were somnolence, decreased appetite, agitation, ataxia, decreased weight, hypotonia, nausea, tremor, dysarthria, and insomnia. PREGNANCY There are no adequate data on the developmental risks associated with the use of DIACOMIT in pregnant women. Based on animal data, DIACOMIT may cause fetal harm. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as DIACOMIT, during pregnancy. Physicians are advised to recommend that pregnant patients taking DIACOMIT enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry (information at ). This can be done by calling the toll-free number 1‑888‑233-2334 and must be done by patients themselves or their caregiver. To report suspected adverse reactions, contact Biocodex at 1‑866‑330-3050 or FDA at 1‑800‑FDA‑1088 or . Please see full DIACOMIT Prescribing Information at . References: 1. Dravet C. The core Dravet syndrome phenotype. Epilepsia. 2011;52 Suppl 2:3-9.doi:10.1111/j.1528-1167.2011.02994. 2. Genton P, Velizarova R, Dravet C. Dravet syndrome: the long-term outcome. Epilepsia. 2011;52 Suppl 2:44-49. doi:10.1111/j.1528-1167.2011.03001. 3. Wu YW, Sullivan J, McDaniel SS, et al. Incidence of Dravet Syndrome in a US Population. Pediatrics. 2015;136(5):e1310-e1315. doi:10.1542/peds.2015-1807 © 2024 Biocodex, Inc. All rights reserved. DIACOMIT® is a registered trademark of Biocodex, Inc. SOURCE Biocodex, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED