Neurelis Announces National Wholesale And Retailer Chains And Independent Pharmacies Are Now Stocking VALTOCO® (Diazepam Nasal Spray)

SAN DIEGO, Nov. 9, 2020 /PRNewswire/ -- Neurelis, Inc., announced today that the company's lead product, VALTOCO^® (diazepam nasal spray), is now available through pharmacies nationwide. VALTOCO was approved by the FDA earlier this year 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 adult and pediatric patients 6 years of age and older. At the time of approval, the FDA also granted VALTOCO 7 years of Orphan Drug Exclusivity. The FDA recognized VALTOCO's intranasal route of administration as clinically superior to the previously approved standard-of-care treatment (a rectal gel formulation of diazepam) as the basis for granting Orphan Drug Exclusivity.

Initially, VALTOCO was made available exclusively through Maxor Specialty Pharmacy.  "Our goal has been to consistently provide broad and reliable access to VALTOCO for patients in the epilepsy community who may benefit from this important medication," said Craig Chambliss, the company's President and Chief Executive Officer. "Seizure episodes can happen at any time and any place. Patients, care partners, and healthcare providers need a reliable product that is available when and where they need it."

Chuck DeWildt, Chief Commercial Officer at Neurelis, added, "VALTOCO's availability through retail chains and independent pharmacies will now allow patients to pick up their prescriptions at their preferred outlet, including health system pharmacies and institutional pharmacies. Hospitals, outpatient clinics, and long-term care facilities can now also stock VALTOCO. Our mission is to make access to VALTOCO as simple as possible for people living with epilepsy and their families. VALTOCO will also continue to be available through Maxor Specialty Pharmacy for customers who prefer to use Maxor for a specialty pharmacy experience."

DeWildt said Neurelis will continue to offer patient assistance programs in the form of copay assistance for commercial patients (through which eligible patients could pay as little as $20 for a prescription) and a patient assistance program in which eligible patients who do not have insurance may qualify for additional assistance. "These programs have taken on added importance because of the COVID-19 pandemic and we remain committed to providing access to anyone who is prescribed VALTOCO," DeWildt said. For additional information, people are urged  to visit www.valtoco.com or contact myNEURELIS™ at 866.696.3873 or by visiting www.myNEURELIS.com. myNEURELIS provides individualized support for VALTOCO patients, including access to nurse educators, insurance coverage checks, financial assistance for those who need it, and more.

In the United States, there are more than 3.4 million people with epilepsy, with approximately 200,000 new patients diagnosed each year. Despite the availability of daily oral medications to control chronic epilepsy, a significant number of these patients continue to experience seizures. Of these uncontrolled patients, as many as 170,000 are at risk for episodes of frequent seizure activity, also known as cluster or acute repetitive seizures, representing a significant unmet need in the epilepsy community.

About VALTOCO

VALTOCO is a proprietary formulation of diazepam incorporating the science of Intravail^®. Intravail 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 FDA 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). In a long-term, open-label, repeat-dose clinical trial, the safety of VALTOCO was evaluated and more than 4,000 seizures were treated. The clinical trial included adult and pediatric patients aged 6 and older. VALTOCO was generally safe and well tolerated during clinical studies. The most common adverse reactions for diazepam (at least 4%) were somnolence, headache, and nasal discomfort. For more information on VALTOCO, please visit www.valtoco.com.

About Neurelis

Neurelis, Inc., is an innovation-driven neuroscience company providing a highly differentiated approach to target unmet medical needs. Neurelis is focused on the development and commercialization of product candidates for epilepsy and the broader central nervous system (CNS) market. On January 10, 2020, the U.S. Food and Drug Administration (FDA) approved Neurelis' VALTOCO^® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, 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. In addition to VALTOCO, the company 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 psychomotor agitation (PMA) symptoms outside of the medical setting. The Neurelis technology platform includes Intravail^®, ProTek^® and Hydrogel^™, three proprietary, noninvasive drug-delivery and stabilization technologies applicable to a wide range of molecules, including therapeutic proteins, peptides, non-peptide macromolecules, and small molecules. For more information on Neurelis, please visit www.neurelis.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.

IMPORTANT SAFETY INFORMATION

RISK FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

• Reserve concomitant prescribing of these drugs for use in 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
• Contraindications: VALTOCO is contraindicated in patients with:
• Known 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. Advise patients and caregivers to be alert for these behavioral changes and to immediately report them to a healthcare provider.

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.

For More Information:

Mark Leonard
[email protected]
858-251-2100

SOURCE Neurelis, Inc.