Seventy-two of 85 adult patients with seizure clusters who were enrolled in the long-term, Phase 3, open-label clinical trial of VALTOCO® (diazepam nasal spray) reported stable or increased Quality of Life (QoL) during the study, according to recent findings published online in the leading journal, Epilepsy & Behavior.
| -Mean total Quality-of-Life scores in patients reporting data at one or more timepoints demonstrated a clinically important improvement during the 12-month study -Reduced seizure worry and improved social functioning were the most significant findings SAN DIEGO, July 20, 2022 /PRNewswire/ -- Seventy-two of 85 adult patients with seizure clusters who were enrolled in the long-term, Phase 3, open-label clinical trial of VALTOCO® (diazepam nasal spray) reported stable or increased Quality of Life (QoL) during the study, according to recent findings published online in the leading journal, Epilepsy & Behavior.
“Caregivers and patients with seizure clusters worry about when the next seizure is going to happen,” said Adrian Rabinowicz, MD, SVP Clinical Development and Medical Affairs. “These findings indicate that if we can reduce the number of seizure clusters with acute, rapid therapies, we potentially can have an impact on both seizure worry and social functioning.” Until now, limited research has been conducted to assess QoL as a potential secondary endpoint in patients with seizure clusters. The 12-month study of diazepam nasal spray enrolled patients 6-to-65 years with seizure clusters. Adults ≥18 years completed the Quality of Life in Epilepsy (QOLIE)-31-P at baseline (day 0) and days 30, 150, 270, and 365. Participants answered questions about their health and daily activities, and responses were assigned numeric values (1-100). Higher scores indicated better QoL. “These findings suggest the need for further study of the impact of acute, rapid therapies on QoL in this patient population,” said Sunita Misra, MD, Senior Medical Director at Neurelis. “Patients and caregivers need to feel empowered by a treatment plan that may reduce their seizure clusters while potentially improving their overall quality of life.” QoL measures included seizure worry, overall QoL, emotional wellbeing, energy/fatigue, cognitive functioning, medication effects, and social functioning. About Neurelis Neurelis, Inc., is a commercial-stage neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need. In 2020, the FDA 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®. Intravail’s transmucosal absorption enhancement technology enables the noninvasive delivery of a broad range of protein, peptide and small-molecule drugs. In its approval of VALTOCO, the U.S. Food and Drug Administration also granted Neurelis Orphan Drug Exclusivity and recognized VALTOCO’s intranasal route of administration as a clinically superior contribution to patient care over the previously approved standard-of-care treatment (a rectal gel formulation of diazepam). For more information on VALTOCO, please visit http://www.valtoco.com/. In addition to VALTOCO, Neurelis is developing NRL-2 for intermittent use to control acute panic attacks, NRL-3 as a noninvasive acute therapy to stop seizures that have progressed to status epilepticus, and NRL-4 as a noninvasive rescue therapy to address the escalation of acute agitation symptoms associated with schizophrenia and bipolar 1 mania in adults. In addition, Neurelis is developing NRL-1049 (previously known as BA-1049), an investigational, pre-clinical stage small molecule 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 http://www.neurelis.com/. For the latest scientific information on VALTOCO, please visit http://www.neurelismedicalaffairs.com/. 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
Contraindications: VALTOCO is contraindicated in patients with:
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. 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 (www.fda.gov/medwatch). Please read full Prescribing Information, including Boxed Warning, for additional important safety information. Contacts:
SOURCE Neurelis, Inc. |
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