Neurelis, Inc., Little Angels Service Dogs Present Aug. 25 "Barks 'n Blues Music & More" Concert to Build Epilepsy Awareness at Local Community Event

 SAN DIEGO, Aug. 19, 2022 /PRNewswire/ -- Neurelis and Little Angels Service Dogs are proud to present the "Barks 'n Blues Music & More" concert for epilepsy awareness at the Quartyard, 1301 Market St., San Diego, Thursday, Aug. 25 at 5 p.m. PT. Featured performers include five-time San Diego Music Award winner, Whitney Shay, San Diego Music Award nominee, Ron Houston & The Berry Pickers, and former American Idol finalist, Jessica Meuse.

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 that live and assist a person with epilepsy. Throughout their training process the puppies will appear at epilepsy-related events like Barks 'n Blues to drive awareness about 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 effectively treat their seizures, return back to their daily lives, and reduce worry about when the next seizure will occur," said Craig Chambliss, CEO, and President. "We are committed to working with Little Angels to reduce fear and stigma associated with epilepsy and educate people with epilepsy and their care partners about the importance of having a seizure action plan in place."

Little Angels Executive Director 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 assisting people at the onset of, during, and after seizure episodes. We hope to improve the potential for positive outcomes for people with epilepsy, one seizure response dog at a time."

Barks 'n Blues will include service dog demonstrations, food and refreshments, and a silent auction featuring attractions, dining, trips, sports tickets, memorabilia, and a chance to meet and name a litter of future service dogs. Tickets can be purchased in advance for $25 on Eventbrite through Aug. 24, or for $30 on Aug. 25, based on availability.

Little Angels Service Dogs, with locations in Jamul, CA and Bartlett, NH, is an Assistance Dog International (ADI) accredited organization that specializes 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.

For more information, to buy tickets, or to find "Barks 'n Blues Music & 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 therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need. In 2020, the FDA approved Neurelis's VALTOCO^® (diazepam nasal spray) CIV 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 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 www.neurelis.com. For the latest scientific information on VALTOCO, please visit www.neurelismedicalaffairs.com.

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.

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:

Little Angels Service Dogs
Melody Nestor, Little Angels Service Dogs, + 1 603-662-5672

Media:
Erich Sandoval, Finn Partners, + 1 917-497-2867 

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SOURCE Neurelis, Inc.