SAN DIEGO, August 19, 2022 /PRNewswire/ — Neurelis and Little Angels Service Dogs are proud to present the “Barks ‘n Blues Music and More” Quartyard Epilepsy Awareness Concert, 1301 Market St., San Diego, Thursday, August 25 a 5 p.m. (Pacific Time). Featured artists include five times San Diego Music Award Winnerwhitneyshay, San Diego Music Award NomineeRon Houston & The Berry Pickers, and former american idol finalist, Jessica Mosa.
The event kicks off a two-year partnership between Neurelis and Little Angels. Neurelis is sponsoring two puppies who will undergo extensive training to become seizure response dogs who live with and help a person with epilepsy. Throughout their training process the puppies will appear at events related to epilepsy such as barks and blues to raise awareness of the disorder along with the critical role of seizure management.
“Our partnership with Little Angels is an extension of our mission to improve the lives of people with epilepsy and empower them to treat their seizures effectively, return to their daily lives and reduce worry about when the next seizure will occur,” he said. craig chambliss, CEO and President. “We are committed to working with Little Angels to reduce the fear and stigma associated with epilepsy and to educate people with epilepsy and their caregivers about the importance of having a seizure action plan.”
Executive Director of Little Angels Josh Drew“Our partnership with Neurelis at the Barks ‘n Blues concert is a great opportunity to educate the public about the critical role service dogs play in alerting and helping people at the onset, during and after seizure episodes. We look forward to improve the potential for positive outcomes for people with epilepsy, one seizure response dog at a time.”
barks and blues will include service dog demonstrations, food and snacks, and a silent auction with rides, dinners, trips, sporting event tickets, memorabilia and the opportunity to meet and name a litter of future service dogs. Tickets can be purchased in advance for $25 on Eventbrite via August 24or by $30 in August 25thaccording to availability.
Little Angels Service Dogs, with locations in Jamul, Calif. Y Bartlett, New Hampshireis an Assistance Dog International (ADI) accredited organization specializing in training service dogs for mobility assistance, seizure alert, autism assistance, hearing alert, diabetic alert, and psychiatric assistance for children and adults of all ages .
To learn more, buy tickets, or find “Barks ‘n Blues Music and More” on Eventbrite or Facebook, visit www.littleangelssd.org/events, or call 603-374-5156, option 4.
Neurelis, Inc., is a commercial-stage neuroscience company focused on the development and commercialization of therapies for the treatment of epilepsy and orphan neurological disorders characterized by high unmet medical need. In 2020, the FDA approved VALTOCO from Neurelis® (diazepam nasal spray) IVC as an acute treatment of stereotypic and intermittent episodes of frequent seizure activity (i.e., cluster seizures, repetitive acute seizures) that are distinct from an individual’s usual seizure pattern in adult and pediatric patients 6 years of age age and older. VALTOCO is a proprietary formulation of diazepam that incorporates the science of INTRAVAIL®. Intravail’s transmucosal absorption enhancement technology enables non-invasive delivery of a wide range of proteins, peptides and small molecule drugs. In its approval of VALTOCO, the US Food and Drug Administration also granted orphan drug exclusivity to Neurelis and recognized the intranasal route of administration of VALTOCO as a clinically superior contribution to patient care over standard treatment of previously approved care (a rectal gel formulation of diazepam). For more information about VALTOCO, visit www.valtoco.com. In addition to VALTOCO, Neurelis is developing NRL-2 for intermittent use to control acute panic attacks, NRL-3 as acute noninvasive therapy to stop seizures that have progressed to status epilepticus, and NRL-4 as noninvasive rescue therapy for address the increased symptoms of acute agitation associated with schizophrenia and bipolar 1 mania in adults. In addition, Neurelis is developing NRL-1049 (formerly known as BA-1049), an investigational preclinical small molecule Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CSCM), a rare disorder. of the central nervous system (CNS). For more information about Neurelis, visit www.neurelis.com. For the latest scientific information on VALTOCO, visit www.neurelismedicalaffairs.com.
Important safety information about VALTOCO:
VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of stereotypic and intermittent episodes of frequent seizure activity (i.e., cluster seizures, repetitive acute seizures) that are distinct from the usual seizure pattern of a 6-year-old patient with epilepsy And older.
WARNING: RISKS OF CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE AND ADDICTION; and REACTIONS OF DEPENDENCE AND WITHDRAWAL
- Concomitant use of benzodiazepines and opioids can result in profound sedation, respiratory depression, coma, and death. Reserve the concomitant prescription of these drugs for patients for whom alternative treatment options are inappropriate. Limit doses 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. The abuse and misuse of benzodiazepines commonly involves the concomitant use of other medications, alcohol, and/or illicit substances, which is associated with a higher frequency of serious adverse outcomes. Before prescribing VALTOCO and during treatment, assess each patient’s risk of abuse, misuse, and addiction.
- Continued use of benzodiazepines can lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer duration of treatment and higher daily dose. Although VALTOCO is indicated for intermittent use only, if used more frequently than recommended, abrupt discontinuation or rapid dose 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 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, can cause CNS depression. Advise patients not to engage in hazardous activities that require alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until drug effects, such as drowsiness, have subsided and their medical condition permits.
The potential for a synergistic CNS depressant effect should be considered when VALTOCO is used with alcohol or other CNS depressants, and appropriate recommendations made to the patient and/or caregiver.
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 new or worsening depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior.
Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO can 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 newborns or infants. Serious and fatal adverse reactions, including “gasping syndrome”, may occur in neonates and low birth weight infants treated with drugs preserved in benzyl alcohol, including VALTOCO. “Wheezing syndrome” is characterized by central nervous system depression, metabolic acidosis, and shortness of breath. The lowest amount of benzyl alcohol at which serious adverse reactions can occur is unknown.
The most common adverse reactions (at least 4%) were drowsiness, 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 see full Prescribing Information, including Boxed Warning, for additional important safety information.
Little Angels Service Dogs
Melody NestorLittle Angels Service Dogs, +1 603-662-5672
Eric SandovalFinn Partners, +1 917-497-2867
SOURCE Neurelis, Inc.