Diazepam

One of the largest gatherings of people with epilepsy, care partners, and healthcare practitioners to address unmet needs for increased education SAN DIEGO, Nov. 18, 2024 /PRNewswire/ -- Neurelis, Inc., today announced it will participate in the 12th Annual Sofie's Journey Epilepsy Awareness Day & Education Expo at Disneyland (EADDL), one of the largest gatherings of people with epilepsy, care partners, and healthcare practitioners. The event was established to help address the unmet need for increased education for people with epilepsy and their families. Neurelis will participate in the free education expo November 18th and 19th, 9:00 AM to 5:00 PM at the Disneyland Hotel Convention Center. Epilepsy Awareness Day will take place on Nov. 20th at Disneyland Resort, where families will spend the day in the park together. "Participating in the Epilepsy Awareness Day event is such a valuable opportunity for me and people in the epilepsy community to learn about progress in the field and exchange information with other families and medical professionals," commented Colleen, care partner and Neurelis Ambassador. "It is an honor to represent Neurelis at the Expo and share my experience with VALTOCO® (diazepam nasal spray), an immediate-use seizure medication which has been key to having my son, Paul, and I feel prepared to address his seizure clusters." "Since I found VALTOCO, I feel I have more freedom to go out and do things and want to help others with seizure clusters realize there may be treatment options to help them experience that too. It means a lot to be able to share my story with kids and young adults with epilepsy, so they understand that they have support from a community of their peers," added Paul, person with epilepsy and Neurelis Ambassador. Neurelis will sponsor a presentation on its FDA-approved product, VALTOCO, a treatment for episodes of frequent seizures in patients six years of age or older, on Monday Nov. 18th from 11:00 AM to 11:30 AM in the Expo Center, Room D. The presentation will feature Paul with his care partner and mother Colleen, who will speak about their journey with epilepsy and answer questions during a live Q&A. Paul was diagnosed with epilepsy when he was 12 years old. Navigating his diagnosis and effectively managing his seizures and seizure clusters, as well as advocating for proper care of students with epilepsy have been a key focus for both Paul and Colleen following his diagnosis. Together they helped create legislation for seizure safe schools in the state of New Jersey, Paul's Law. Paul is now successfully attending college and enjoys golf. Colleen continues her advocacy efforts and is currently working on advancing the Seizure Awareness and Preparedness Act. Joining Neurelis and the epilepsy community at the Expo will also be Neurelis Ambassador Danielle. Danielle was diagnosed with epilepsy almost 25 years ago, after she was unable to wake up for school one day. Epilepsy significantly impacted her life during her adolescence and college years. Now with proper management, a detailed seizure action plan, and a strong support system, Danielle has been able to increase her independence. She served as president of a regional epilepsy nonprofit focused on helping people with epilepsy to manage the logistics of accessing appropriate healthcare. She continues to be dedicated to increasing advocacy and awareness for people with epilepsy. Danielle spoke about her experiences living with and managing seizure clusters on Sunday Nov. 17 at a dinner co-sponsored by Epilepsy Alliance of America for families attending the meeting. "VALTOCO has enabled me to have more freedom to travel and give back to the epilepsy community through my advocacy work," said Danielle. "It is exciting to participate in the Epilepsy Awareness Day Expo which is such a powerful event for learning and creating a community. Having the opportunity to engage with doctors, caregivers, and others who live daily with the challenges of epilepsy gives a sense of empowerment and support." "Our focus at Neurelis has been on improving overall care and increasing awareness of the unmet needs of people with epilepsy," said Neurelis Founder and CEO Craig Chambliss. "We are proud to join the epilepsy community at this important event to promote education and to help advance the discussion on how to empower people with epilepsy and improve the quality of their lives." Additionally, Neurelis has committed to sponsoring two new seizure detection and response puppies through Little Angels Service Dogs, an Assistance Dog International accredited organization that specializes in training service dogs for seizure alert and several other types of assistance. The puppies will be featured at the VALTOCO exhibit booth. EADDL is part of November's National Epilepsy Awareness Month, which promotes the importance of epilepsy education and awareness, and improving the lives of those impacted by the condition. For more information about EADDL, visit and to register for the Expo, click here. About EADDL and Sofie's Journey EADDL is the combined effort of one family's thankfulness for their own daughter's recovery (10+ years seizure free) and a united community with a passion for winning the fight against epilepsy. It is operated by the Irvine, Calif.-based, non-profit foundation, Sofie's Journey, to drive epilepsy awareness by bringing together patients, families/caregivers, physicians, advocates, non-profits, services, and the biopharmaceutical industry. EADDL and Sofie's Journey were launched by Candy and Brad Levy, whose daughter Sofie, now 19 years old, underwent surgery in 2013 to remove a part of her brain that caused her seizures. Their mission is to drive epilepsy awareness, the key to overcoming challenges created by epilepsy. About Neurelis Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and neurologic disorders characterized by high unmet medical need. The FDA has approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®, a transmucosal absorption enhancement technology that enables the noninvasive delivery of a broad range of protein, peptide, and small-molecule drugs. For more information on VALTOCO, please visit . For the latest scientific information on VALTOCO, please visit . Neurelis is also developing NRL-1004, an investigational, Phase 1 stage intranasal olanzapine for treatment of acute agitation episodes associated with schizophrenia and bipolar disorder. In addition, Neurelis is also developing NRL-1049 (previously known as BA-1049), an investigational, Phase 1 new chemical entity Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit . Important Safety Information about VALTOCO: Indication VALTOCO® (diazepam nasal spray) 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 6 years of age and older. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines 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. The use of benzodiazepines, including VALTOCO, 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 VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. 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 VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO. Contraindications: VALTOCO is contraindicated in patients with: Hypersensitivity to diazepam Acute narrow-angle glaucoma Central Nervous System (CNS) Depression Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits. The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and 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 unusual changes in mood or behavior. Glaucoma Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma. Neonatal Sedation and Withdrawal Syndrome Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly. Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Adverse Reactions The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort. Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance. To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (). Please read full Prescribing Information , including Boxed Warning. Contacts: Brittany Bradrick, Chief Operating Officer and Chief Financial Officer, +1 858 251 2100 SOURCE Neurelis, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Presentation highlights study-enrollment challenges and strategies to overcome potential barriers SAN DIEGO, Nov. 11, 2024 /PRNewswire/ -- Neurelis, Inc., today announced a presentation on insights into study design from the enrollment process for the new Stellina study investigating VALTOCO® (diazepam nasal spray) for the treatment of seizure clusters in patients with epilepsy aged 2 to 5 years. This age group is not included in the current indication of treatment of seizure clusters in patients with epilepsy aged ≥6 years. The poster presentation will be given at the 53rd Child Neurology Society Annual Meeting in San Diego, November 11-14th. "Data from clinical studies of repetitive seizures in early childhood are critical to help advance new treatments for a young population with currently limited alternatives," said Adrian L. Rabinowicz, MD, Neurelis Chief Medical Officer. "We are pleased to join the child neurology community and exchange learnings at this year's annual meeting as we focus on improving health outcomes for people with epilepsy." Highlights of the presentation include the identification of study-enrollment challenges and strategies to overcome potential barriers in young patients with treatment-resistant epilepsy. Identified findings may be helpful in designing future protocols. The poster titled "Challenges Associated with Enrolling Pediatric Patients with Treatment-Resistant Epilepsy Aged 2–5 Years in a Clinical Trial and Lessons Learned for Future Trials" will be presented on Tuesday November 12th from 12:30 PM-1:45 PM and 5:30 PM-7:00 PM PT. The mission of the Child Neurology Society is to raise awareness about the importance of child neurologists and the health needs of children with chronic neurological conditions. About Neurelis Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and neurologic disorders characterized by high unmet medical need. The FDA has approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®, a transmucosal absorption enhancement technology that enables the noninvasive delivery of a broad range of protein, peptide and small-molecule drugs. For more information on VALTOCO, please visit . For the latest scientific information on VALTOCO, please visit . Neurelis is also developing NRL-1004, an investigational, Phase 1 stage intranasal olanzapine for treatment of acute agitation episodes associated with schizophrenia and bipolar disorder. In addition, Neurelis is also developing NRL-1049 (previously known as BA-1049), an investigational, Phase 1 new chemical entity Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit . Important Safety Information about VALTOCO: Indication VALTOCO® (diazepam nasal spray) 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 6 years of age and older. Contraindications: VALTOCO is contraindicated in patients with: Hypersensitivity to diazepam Acute narrow-angle glaucoma Central Nervous System (CNS) Depression Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits. The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and 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 unusual changes in mood or behavior. Glaucoma Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma. Neonatal Sedation and Withdrawal Syndrome Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly. Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Adverse Reactions The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort. Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance. To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (). Please read full Prescribing Information , including Boxed Warning. Contacts: Brittany Bradrick, Chief Operating Officer and Chief Financial Officer, +1 858 251 2100 SOURCE Neurelis, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED