Neurelis, Inc., Named To List Of Best Places To Work In Socal 2022

● Company culture cultivates passioned innovation and purpose in employees to empower those impacted by epilepsy and other rare disorders

SAN DIEGO, CA  — August 18, 2022  — Neurelis, Inc., is pleased to announce it has been named one of the Best Places to Work in SoCal 2022 by Best Companies Group (BCG), a BridgeTower Media Company. This distinction is based on responses from a detailed and comprehensive survey of its employees.

“Being named to this list is an incredible honor for all of us,” said Neurelis Chief Executive Officer Craig Chambliss. “We are purposeful in our dedication to each other and those we serve. Many of our team members have a personal connection to epilepsy, which amplifies our responsibility to achieve our number one goal – improving the lives of those impacted by epilepsy.”

BCG’s annual award program identifies and honors the best places to work in Southern California. The ranking is based on anonymous employee surveys and an analysis of their responses about corporate culture, training and development, salary and benefits, and overall employee satisfaction.

“Neurelis is proud to have launched multiple initiatives that support and inspire our employees,” said Shaun Winn, Senior Director, Human Resources, Neurelis. “These include mentorship opportunities, special committees like ‘Women at Neurelis and their allies’, The Culture Crew, Flex Time Off, company bought lunches, a Wellness Room, and embracing many Epilepsy events across the country, including events like EpiCon, a three-day convention aimed at empowering the epilepsy community.”

The 136-member Neurelis team is committed to innovating life-changing treatments that empower people with epilepsy to take greater control over their day-to-day lives. The Company is committed to developing therapeutics for the treatment of epilepsy and other CNS disorders. The company’s groundbreaking product, VALTOCO® (diazepam nasal spray) CIV, is an FDA-approved nasal spray for the treatment of frequent seizures in adult and pediatric patients ages 6 years and older.

“Southern California is known for innovation, and the companies that made our Best Places to Work SoCal list take a forward-looking approach to create workplaces of excellence,” said Jaime Raul Zepeda, Executive Vice President of Best Companies Group. “Our research proves that Neurelis is committed to developing a highly engaged and valued workforce.”

BCG will host a virtual awards ceremony honoring and celebrating the winners on Sept. 29. For a complete list of the Great Employers to Work for in SoCal 2022, please visit the Best Companies Group website at https://bestcompaniesgroup.com/best-places-to-work-southern-california/

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’s 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 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.

Important Safety Information about VALTOCO:

Indication

VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, 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.