SAN DIEGO, June 8, 2020 / PRNewswire / – Neurelis, Inc., today announced that insurers and managed care plans now provide coverage for more than 176 million lives for the company’s flagship product, VALTOCOÂ® (diazepam nasal spray). VALTOCO was approved by the United States Food and Drug Administration (FDA) on January 10, 2020, for the acute treatment of intermittent stereotypical episodes of frequent epileptic activity (ie.
“It is a very positive signal that insurers are quickly providing coverage for VALTOCO,” said Chuck DeWildt, commercial director of the company. âWe accomplished in just over four months what takes up to a year for many companies. look forward to covering even more lives in the months to come to deliver this important product to those who need it. “
In 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 chronic, daily oral medications to control epilepsy, a significant number of these patients continue to have seizures. Of these uncontrolled patients, up to 170,000 are at risk for episodes of frequent epileptic activity, also called acute repetitive seizures, which represents a significant unmet need in the epileptic community.
DeWildt added that Neurelis has launched a patient assistance program to support eligible patients who do not have access to insurance. In addition, he said, the company’s co-payment plan was able to help patients eligible for commercial insurance pay as little as $ 20 for VALTOCO. âThese plans take on even greater importance at a time when the COVID-19 pandemic has affected so many economically, including those in the epilepsy community,â DeWildt said.
Another important program initiated by the company is myNEURELIS â¢. myNEURELIS provides one-on-one support to VALTOCO patients, including access to nurse educators, insurance coverage checks, financial assistance for those in need, etc. For more information, please visit www.myNEURELIS.com.
âWe understand that the epilepsy community has been waiting for more than two decades for a version of diazepam that comes in an effective combination of reliability, safety and tolerance in a ready-to-use nasal spray,â said DeWildt. “We are very grateful to be able to bring VALTOCO to the community and remain committed to providing access to this vital drug to all who need it.”
VALTOCO is a proprietary formulation of diazepam incorporating the science of WorkÂ®. Intravail transmucosal absorption enhancement technology enables non-invasive delivery of a wide range of protein, peptide and small molecule drugs. In its approval of VALTOCO, the FDA recognized the intranasal route of administration of VALTOCO as clinically superior to the previously approved reference treatment (a rectal gel formulation of diazepam). In a long-term, open-label, repeated dose clinical trial, the safety of VALTOCO has been evaluated and over 4000 seizures have been treated. The clinical trial included adult and pediatric patients aged 6 years and older. VALTOCO was generally safe and well tolerated in clinical studies. The most common side effects of diazepam (at least 4%) were drowsiness, headache, and nasal discomfort. For more information on VALTOCO, please visit www.valtoco.com.
Neurelis, Inc. is an innovation-driven neuroscience company that offers a highly differentiated approach to targeting unmet medical needs. Neurelis is focused on the development and commercialization of product candidates for epilepsy and the broader central nervous system (CNS) market. At January 10, 2020, the United States Food and Drug Administration (FDA) has approved Neurelis’ VALTOCOÂ® (diazepam nasal spray) as an acute treatment for intermittent stereotypical episodes of frequent epileptic activity (i.e. In addition to VALTOCO, the company is developing NRL-2 for intermittent use to control acute panic attacks, NRL-3 as an acute non-invasive therapy to arrest seizures that have progressed to status epilepticus, and NRL-4 as a non-invasive rescue therapy to treat escalating symptoms of psychomotor agitation (PMA) outside of the setting The Neurelis technology platform includes IntravailÂ®, ProTekÂ® and Hydrogelâ¢, three proprietary non-invasive 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 VALTOCOÂ® (diazepam nasal spray) is indicated for the acute treatment of stereotypical, intermittent episodes of frequent seizure activity (i.e., epileptic activity).
IMPORTANT SAFETY INFORMATION
RISK OF CONCURRENT USE WITH OPIODS
Concomitant use of benzodiazepines and opioids can 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 times to the minimum required
Monitor patients for signs and symptoms of respiratory depression and sedation
Contraindications: VALTOCO is contraindicated in patients with:
Known hypersensitivity to diazepam
Acute angle-closure glaucoma
Central nervous system (CNS) depression
Benzodiazepines, including VALTOCO, can cause CNS depression. Warn patients not to engage 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 their state of health permits.
The potential for a synergistic CNS depressant effect when VALTOCO is used with alcohol or other CNS depressants should 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 thoughts and behavior. Patients treated with an AED for any indication should be monitored for new or worsening depression, suicidal thoughts or behavior, and / or unusual changes in mood or behavior. Advise patients and caregivers to be alert to these behavioral changes and to report them immediately to a healthcare practitioner.
Benzodiazepines, including VALTOCO, may increase intraocular pressure in patients with glaucoma. VALTOCO can only be used in patients with open angle glaucoma if they are receiving appropriate treatment. VALTOCO is contraindicated in patients with narrow-angle glaucoma.
Risk of serious side effects in infants due to preservative benzyl alcohol
VALTOCO is not approved for use in newborns or infants. Serious and fatal side effects, including âpanting syndromeâ, can occur in newborns and low birth weight infants treated with medicines containing benzyl alcohol, including VALTOCO. âPanting syndromeâ is characterized by central nervous system depression, metabolic acidosis, and gasping breaths. The minimum amount of benzyl alcohol at which serious side effects can occur is not known.
The most common side effects (at least 4%) were drowsiness, headache and nasal discomfort.
Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance.
To report SUSPECTED SIDE EFFECTS, contact Neurelis, Inc. at 1-866-696-3873 or the FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).