NEURELIS ANNOUNCES PARTNERSHIP WITH RICK HARRISON, HOST OF TV’S “PAWN STARS” AND EPILEPSY ADVOCATE, TO RAISE AWARENESS OF EPILEPSY AND NEED FOR MORE EDUCATION REGARDING SEIZURE EMERGENCIES
SAN DIEGO, CA — December 3, 2021 — Neurelis, Inc., announced today that it is partnering with epilepsy education advocate Rick Harrison, star of TV’s “Pawn Stars,” to raise awareness of epilepsy and the need for more education regarding seizure emergencies. Harrison was diagnosed at age 8 with focal onset aware seizures and suffered from seizures through adolescence.
“There is a high unmet need in the epilepsy community for more education about epilepsy as well as seizure emergencies,” said Craig C. Chambliss, President and Chief Executive Officer of Neurelis. “Rick Harrison has been a passionate advocate for epilepsy education having suffered the impact of seizures as a child and adolescent that impacted his ability to live a normal life. We’re excited to partner with Rick on initiatives to educate the epilepsy community and general public about seizure emergencies and the importance of seizure action plans and learning seizure first aid.”
At age 8, Harrison said he began suffering from seizures that occurred once a month until he was 18. “Because of the seizures, I couldn’t participate in many activities that a normal child could,” he said. “I spent a lot of time at home in my room which has led to my lifelong passion of reading and learning about history. At that time, the only plan to manage my seizures was to let them run their course. I appreciate Neurelis giving me a platform to tell my story and to educate more people about epilepsy and seizure emergencies.”
Chambliss said Harrison would be meeting with physicians and members of the epilepsy community during the American Epilepsy Society annual meeting in Chicago starting on December 4. In addition, Harrison will be filming informational videos that will be distributed via social media platforms in 2022.
Harrison, who is being compensated for his participation in these educational initiatives, has never been prescribed a Neurelis product.
About Rick Harrison
Rick Harrison, 56, is an American businessman, reality television personality and owner of the Gold & Silver Pawn Shop in Las Vegas which is featured on the History Channel TV series “Pawn Stars.” “Pawn Stars” is now on its 18th season and continues to be a huge hit, airing in more than 150 countries and in over 30 languages. As a child, Harrison suffered from epileptic seizures starting at age 8, which would confine him to bed, and led to his lifelong love of reading. In 2014, Harrison was asked to become the national spokesperson for the Epilepsy Foundation, a role he gladly accepted. When the Epilepsy Foundation started a local chapter for Southern Nevada, Harrison wasted no time in creating his first event – the inaugural “Pawn Stars Poker Run,” which raised more than $100,000 for the Epilepsy Foundation and has now become an annual tradition.
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:
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.
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.
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.