NEW QUALITY OF LIFE DATA FOR VALTOCO® (DIAZEPAM NASAL SPRAY) CIV IN THE TREATMENT OF SEIZURE CLUSTERS PUBLISHED IN EPILEPSY & BEHAVIOR

-Imply whole High quality-of-Life scores in sufferers reporting information at a number of timepoints demonstrated a clinically vital enchancment in the course of the 12-month research

-Diminished seizure fear and improved social functioning had been probably the most vital findings

SAN DIEGO, July 20, 2022 /PRNewswire/ — Seventy-two of 85 grownup sufferers with seizure clusters who had been enrolled within the long-term, Section 3, open-label scientific trial of VALTOCO® (diazepam nasal spray) reported steady or elevated High quality of Life (QoL) in the course of the research, based on latest findings printed on-line within the main journal, Epilepsy & Habits.

“Caregivers and sufferers with seizure clusters fear about when the subsequent seizure goes to occur,” stated Adrian Rabinowicz, MD, SVP Medical Improvement and Medical Affairs. “These findings point out that if we will scale back the variety of seizure clusters with acute, speedy therapies, we probably can have an effect on each seizure fear and social functioning.”

Till now, restricted analysis has been performed to evaluate QoL as a possible secondary endpoint in sufferers with seizure clusters. The 12-month research of diazepam nasal spray enrolled sufferers 6-to-65 years with seizure clusters. Adults ≥18 years accomplished the High quality of Life in Epilepsy (QOLIE)-31-P at baseline (day 0) and days 30, 150, 270, and 365. Members answered questions on their well being and day by day actions, and responses had been assigned numeric values (1-100). Larger scores indicated higher QoL.

“These findings counsel the necessity for additional research of the affect of acute, speedy therapies on QoL on this affected person inhabitants,” stated Sunita Misra, MD, Senior Medical Director at Neurelis. “Sufferers and caregivers have to really feel empowered by a remedy plan which will scale back their seizure clusters whereas probably bettering their general high quality of life.”

QoL measures included seizure fear, general QoL, emotional wellbeing, power/fatigue, cognitive functioning, medicine results, and social functioning.

About Neurelis

Neurelis, Inc., is a commercial-stage neuroscience firm targeted on the event and commercialization of therapeutics for the remedy of epilepsy and orphan neurologic issues characterised by excessive unmet medical want. In 2020, the FDA authorised Neurelis’ VALTOCO^® (diazepam nasal spray) as an acute remedy of intermittent, stereotypic episodes of frequent seizure exercise (i.e., seizure clusters, acute repetitive seizures) which might be distinct from a person’s regular seizure sample in grownup and pediatric sufferers 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL^®. Intravail’s transmucosal absorption enhancement expertise permits the noninvasive supply of a broad vary of protein, peptide and small-molecule medicine. In its approval of VALTOCO, the U.S. Meals and Drug Administration additionally granted Neurelis Orphan Drug Exclusivity and acknowledged VALTOCO’s intranasal route of administration as a clinically superior contribution to affected person care over the beforehand authorised standard-of-care remedy (a rectal gel formulation of diazepam). For extra info on VALTOCO, please go to http://www.valtoco.com/. Along with VALTOCO, Neurelis is growing NRL-2 for intermittent use to manage acute panic assaults, NRL-3 as a noninvasive acute remedy to cease seizures which have progressed to standing epilepticus, and NRL-4 as a noninvasive rescue remedy to handle the escalation of acute agitation signs related to schizophrenia and bipolar 1 mania in adults. As well as, Neurelis is growing NRL-1049 (beforehand often called BA-1049), an investigational, pre-clinical stage small molecule Rho kinase (ROCK) inhibitor, for the remedy of cerebral cavernous malformations (CCMS), a uncommon dysfunction of the central nervous system (CNS). For extra info on Neurelis, please go to http://www.neurelis.com/. For the most recent scientific info on VALTOCO, please go to http://www.neurelismedicalaffairs.com/.

Necessary Security Details about VALTOCO:

Indication

VALTOCO^® (diazepam nasal spray) is indicated for the acute remedy of intermittent, stereotypic episodes of frequent seizure exercise (i.e., seizure clusters, acute repetitive seizures) which might be distinct from a affected person’s regular seizure sample in sufferers 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 might end in profound sedation, respiratory despair, coma, and demise. Reserve concomitant prescribing of those medicine for sufferers for whom various remedy choices are insufficient. Restrict dosages and durations to the minimal required. Comply with sufferers for indicators and signs of respiratory despair and sedation.
• Using benzodiazepines, together with VALTOCO, exposes customers to dangers of abuse, misuse, and dependancy, which might result in overdose or demise. Abuse and misuse of benzodiazepines generally contain concomitant use of different medicines, alcohol, and/or illicit substances, which is related to an elevated frequency of significant opposed outcomes. Earlier than prescribing VALTOCO and all through remedy, assess every affected person’s danger for abuse, misuse, and dependancy.
• The continued use of benzodiazepines might result in clinically vital bodily dependence. The dangers of dependence and withdrawal improve with longer remedy period and better day by day dose. Though VALTOCO is indicated just for intermittent use, if used extra incessantly than advisable, abrupt discontinuation or speedy dosage discount of VALTOCO might precipitate acute withdrawal reactions, which may be life-threatening. For sufferers utilizing VALTOCO extra incessantly than advisable, to cut back the chance of withdrawal reactions, use a gradual taper to discontinue VALTOCO.

 Contraindications: VALTOCO is contraindicated in sufferers with:

• Hypersensitivity to diazepam
• Acute narrow-angle glaucoma

Central Nervous System (CNS) Melancholy

Benzodiazepines, together with VALTOCO, might produce CNS despair. Warning sufferers towards partaking in hazardous actions requiring psychological alertness, equivalent to working equipment, driving a motorcar, or using a bicycle, till the results of the drug, equivalent to drowsiness, have subsided, and as their medical situation permits.

The potential for a synergistic CNS-depressant impact when VALTOCO is used with alcohol or different CNS depressants have to be thought of, and acceptable suggestions made to the affected person and/or care accomplice.

Suicidal Habits and Ideation

Antiepileptic medicine (AEDs), together with VALTOCO, improve the chance of suicidal ideation and conduct. Sufferers handled with any AED for any indication must be monitored for the emergence or worsening of despair, suicidal ideas or conduct, and/or uncommon adjustments in temper or conduct.

Glaucoma

Benzodiazepines, together with VALTOCO, can improve intraocular strain in sufferers with glaucoma. VALTOCO might solely be utilized in sufferers with open-angle glaucoma provided that they’re receiving acceptable remedy. VALTOCO is contraindicated in sufferers with narrow-angle glaucoma.

Danger of Severe Antagonistic Reactions in Infants attributable to Benzyl Alcohol Preservative

VALTOCO shouldn’t be authorised to be used in neonates or infants. Severe and deadly opposed reactions, together with “gasping syndrome,” can happen in neonates and low-birth-weight infants handled with benzyl alcohol-preserved medicine, together with VALTOCO. The “gasping syndrome” is characterised by central nervous system despair, metabolic acidosis, and gasping respirations. The minimal quantity of benzyl alcohol at which severe opposed reactions might happen shouldn’t be recognized.

Antagonistic Reactions

The commonest opposed reactions (no less than 4%) had been somnolence, headache, and nasal discomfort.

Diazepam, the lively ingredient in VALTOCO, is a Schedule IV managed 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 learn full Prescribing Info, together with Boxed Warning, for extra vital security info.

Contacts:
Neurelis:
Brittany Bradrick, Chief Monetary Officer, +1 858 251 2135
Media: 
Erich Sandoval, Finn Companions, + 1 917 497 2867

SOURCE Neurelis, Inc.