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NEURELIS ANNOUNCES RAPID AND BROAD PAYER COVERAGE OF THE COMPANY'S FLAGSHIP PRODUCT, VALTOCO® (DIAZEPAM NASAL SPRAY)
来源: | 作者:Neurelis, Inc. | 发布时间: 2020-06-09 | 453 次浏览 | 分享到:

SAN DIEGO, CA – June 8, 2020 – 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.