Neurelis’ investigational product candidate, VALTOCO® (diazepam nasal spray), currently under review by the U.S. Food and Drug Administration
| SAN DIEGO, Dec. 5, 2019 /PRNewswire/ -- Neurelis, Inc., a privately held specialty pharmaceutical company focused on licensing, developing and commercializing product candidates for epilepsy and the broader central nervous system market, announced today that the company will have nine poster presentations at the annual meeting of the American Epilepsy Society being held December 6-10 in Baltimore, Maryland.
“During the ongoing clinical development program of the investigational product VALTOCO, over 2,000 seizures have been treated,” said Craig Chambliss, President and CEO of Neurelis. “As a result, we have been able to accumulate a wealth of administration and safety data of VALTOCO use in epilepsy patients experiencing cluster seizures. We are very pleased to be presenting nine posters at AES that support the rigorous science behind VALTOCO. These presentations have been made possible by the outstanding participation of our investigators, their dedicated staff and, most significantly, the patients who participated in these important studies.” The details for the poster presentations are as follows: Saturday, December 7, 2019 Abstract title: Safety and Tolerability of NRL-1, an Intranasal Formulation of Diazepam, in Relationship to Usage Frequency in Subjects With Epilepsy: Interim Results From a Phase 3, Open-label, Repeat Dose Study Poster number: 1.220 Location: Hall E, Level 100 Time: 12 pm – 6 pm Authors present: 12 pm – 2 pm Saturday, December 7, 2019 Abstract title: Safety of Valtoco® (NRL-1; diazepam nasal spray) in Patients With Epilepsy: Interim Results From a Phase 3, Open-Label, 12-Month Repeat Dose Study Poster number: 1.224 Location: Hall E, Level 100 Time: 12 pm – 6 pm Authors present: 12 pm – 2 pm Sunday, December 8, 2019 Abstract title: Pharmacokinetics and Safety of Valtoco® (NRL-1; diazepam nasal spray) in Patients With Epilepsy During Seizure (Ictal/Peri-ictal) and Non-seizure (Inter-ictal) Conditions Poster number: 2.122 Location: Hall E, Level 100 Time: 10 am – 4 pm Authors present: 12 pm – 2 pm Sunday, December 8, 2019 Abstract title: Safety and Tolerability of NRL-1, an Intranasal Formulation of Diazepam, in Subjects with Epilepsy in a Phase 1, Open-Label Study: Focus on Adverse Events Relevant to Clinicians and Patients Poster number: 2.123 Location: Hall E, Level 100 Time: 10 am – 4 pm Authors present: 12 pm – 2 pm Sunday, December 8, 2019 Abstract title: Evaluation of NRL-1, an Intranasal Formulation of Diazepam, in Patients with Epilepsy Concomitantly Using Clobazam: An Interim Subgroup Analysis from a Phase 3, Long-term, Open-Label Study Poster number: 2.124 Location: Hall E, Level 100 Time: 10 am – 4 pm Authors present: 12 pm – 2 pm Sunday, December 8, 2019 Abstract title: Safety of Valtoco® (NRL-1; diazepam nasal spray) Administration During Ictal/Peri-ictal State in an Open-Label Study Poster number: 2.131 Location: Hall E, Level 100 Time: 10 am – 4 pm Authors present: 12 pm – 2 pm Sunday, December 8, 2019 Abstract title: Drug Delivery Technologies to Address Unmet Needs in Epilepsy Poster number: 2.132 Location: Hall E, Level 100 Time: 10 am – 4 pm Authors present: 12 pm – 2 pm Monday, December 8, 2019 Abstract title: Effectiveness and Safety of Valtoco®(NRL-1; diazepam nasal spray) in Patients With Epilepsy and a History of Seasonal Allergies: Interim Results From a Phase 3, Open-Label, 12-Month Repeat Dose Study Poster number: 3.218 Location: Hall E, Level 100 Time: 8 am – 2 pm Authors present: 12 pm – 2 pm Monday, December 8, 2019 Abstract title: A Survey of Epilepsy Digital Technology Awareness and Usage Among Neuroscience Nurses Poster number: 3.411 Location: Hall E, Level 100 Time: 8 am – 2 pm Authors present: 12 pm – 2 pm About VALTOCO The company’s investigational product candidate, VALTOCO® (diazepam nasal spray), is currently under review by the U.S. Food and Drug Administration as a treatment for intermittent use in adults and children 6 years and older with epilepsy, on stable regimens of antiepileptic drugs (AEDs), to control bouts of increased seizure activity, often referred to as cluster or acute repetitive seizures (ARS). VALTOCO is a proprietary formulation of diazepam, incorporating the unique combination of a vitamin E–based solution and Intravail® transmucosal absorption enhancement technology. Despite the availability of chronic, daily oral medications to control epilepsy, it is estimated that 170,000 individuals in the United States are at risk for cluster or acute repetitive seizures. In a long-term, open-label, repeat-dose, clinical trial, the safety of VALTOCO was evaluated: 132 patients were enrolled and 2,274 seizures were treated. Approximately 92% of the seizures treated with a single dose of VALTOCO did not require a second dose within at least 24 hours. The most common adverse reactions (> 2.0%) observed in clinical studies with epilepsy patients included: nasal discomfort (4.7%), dysgeusia (2.1%), epistaxis (2.1%), and headache (2.1%). About Neurelis Neurelis, Inc., is an innovation-driven neuroscience company providing a highly differentiated approach to target unmet medical needs. Neurelis is focused on the development and commercialization of product candidates for epilepsy and the broader central nervous system market. In addition to VALTOCO, the company is developing NRL-2 for intermittent use to control acute anxiety episodes or panic attacks, and NRL-3 as a noninvasive acute therapy to stop seizures that have progressed to status epilepticus. The Neurelis technology platform includes Intravail®, ProTek® and Hydrogel®, three proprietary noninvasive drug-delivery and stabilization technologies applicable to a wide range of molecules, including therapeutic proteins, peptides, non-peptide macromolecules and small molecules. For more information on Neurelis, please visit www.neurelis.com. For More Information:
SOURCE Neurelis, Inc. |
View original content to download multimedia:
