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 News Release - June 8, 2020

Neurelis Announces Rapid and Broad Payer Coverage of the Company's Flagship Product, VALTOCO(R) (Diazepam Nasal Spray)

More than 176 million lives in the U.S. now covered by payers/managed care/insurance plans within months of FDA approval of VALTOCO, the first and only nasal spray treatment of seizure clusters in patients 6 years of age and older

Neurelis' patient assistance program supports eligible patients who have no health insurance

Co-pay program for VALTOCO helps commercial patients lower their out-of-pocket costs to as low as $20


SAN DIEGO, June 8, 2020 -- (Healthcare Sales & Marketing Network) -- Neurelis, Inc., announced today that insurers and managed care plans now provide coverage for more than 176 million lives for the company's lead product, VALTOCO® (diazepam nasal spray). VALTOCO was approved by the U.S. Food and Drug Administration (FDA) on January 10, 2020, 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 adult and pediatric patients 6 years of age and older.

"It is a very positive signal that insurers are quickly providing coverage for VALTOCO," said Chuck DeWildt, the company's Chief Commercial Officer. "We've accomplished in just over four months what takes many companies up to a year to do. I'd like to commend our market access team and the payers for understanding that this is a large unmet need for people with epilepsy and we look forward to even more lives being covered in the coming months to provide this important product to the people who need it."

In the United States, there are over 3.4 million people with epilepsy, with approximately 200,000 new patients diagnosed each year. Despite the availability of chronic, daily oral medications to control 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.

DeWildt added that Neurelis has initiated a patient assistance program to support eligible patients who do not have access to insurance. In addition, he said, the company's co-pay plan has been able to help eligible commercial insurance patients to pay as little as $20 for VALTOCO. "These plans take on even more importance at a time when the COVID-19 pandemic has economically hurt so many people, including those in the epilepsy community," DeWildt said.

One other important program initiated by the company is myNEURELIS™. myNEURELIS provides individualized support for VALTOCO patients, including access to nurse educators, insurance coverage checks, financial assistance for those who need it, and more. For more information, please visit www.myNEURELIS.com.

"We understand that the epilepsy community has been waiting more than two decades for a version of diazepam that is delivered in an effective combination of reliability, safety and tolerability in a ready-to-use nasal spray," DeWildt said. "We are so grateful to be able to bring VALTOCO to the community and remain dedicated to providing access to this vital medication for everyone who needs it."

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 recognized VALTOCO's intranasal route of administration as clinically superior to 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 (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. 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 see full Prescribing Information, including Boxed Warning, for additional important safety information.


Source: Neurelis

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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