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
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."
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.
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.