Neurelis Announces First Product Approved Using The Company's Intravail® Platform

-- Dr. Reddy's Laboratories and its U.S. subsidiary, Promius Pharma, announced U.S. FDA approval on January 28 for its migraine treatment TOSYMRA™ (sumatriptan nasal spray 10 mg) in the United States-- This is the first FDA approval of an investigational drug utilizing the science of Intravail®-- Neurelis' lead product candidate for seizures, VALTOCO™, currently in FDA review, also utilizes the science of Intravail® as a key component of its formulation to deliver diazepam intranasally

News provided by

Neurelis, Inc.

Jan 30, 2019, 09:00 ET

SAN DIEGO, Jan. 30, 2018 /PRNewswire/ -- Neurelis announced today that its Intravail® licensing partner, Dr. Reddy's Laboratories and its U.S. subsidiary, Promius Pharma, LLC, received U.S. Food and Drug Administration (FDA) approval of TOSYMRA™ (sumatriptan nasal spray 10 mg). TOSYMRA™ is indicated for the acute treatment of migraine with or without aura in adults.

Neurelis President and CEO Craig Chambliss stated, "This is a significant development for migraine sufferers and we congratulate the Dr. Reddy's team for bringing this important treatment option to market. It is also an important milestone for Neurelis as TOSYMRA™ is the first product to incorporate Intravail® in an FDA-approved product."

The science of Intravail® enables the non-invasive delivery of a broad range of protein, peptide and non-peptide drugs. Intravail® can be utilized via the oral, buccal, dermal, and intranasal administration routes of drug administration, providing several advantages:

Increased bioavailability – Addressing sub-optimal bioavailability or route-of-administrations
Application to wide range of molecules – Small molecules, therapeutic proteins, peptides, non-peptide macromolecules (up to ~ 30KDa)
Safety – Odorless, tasteless, non-toxic, non-mutagenic and non-irritating
Solubility in water/oils – Compatible with routine liquid formulation and dispensing processes for ease of scale-up and production

VALTOCO™ (diazepam nasal spray), Neurelis' lead product candidate, is a proprietary formulation of diazepam incorporating the unique combination of a vitamin E-based solution with Intravail^®. Currently under FDA review, Neurelis is preparing for the commercial launch of VALTOCO in 2019.

In addition to VALTOCO™, Chambliss said the company's pipeline utilizes Intravail® to develop novel formulations of drugs targeting areas of significant unmet medical needs in Central Nervous System (CNS) diseases. Neurelis is also fortunate to partner Intravail® with a number of licensees furthering the development of important drugs in a variety of diseases and continues to expand its strategic partnerships to benefit patients, caregivers, and healthcare providers.

More About VALTOCO™

VALTOCO™ nasal spray is a proprietary formulation of diazepam, delivered via a nasal spray formulation, developed for the management of pediatric, adolescent, and adult patients who require intermittent use of diazepam to control bouts of increased seizure activity, also known as cluster or acute repetitive seizures. In clinical trials, VALTOCO™ demonstrated high bioavailability, low variability from dose to dose, and was well-tolerated with the most common adverse events being nasal discomfort (seen in 5% of patients in clinical trials). The FDA previously granted Neurelis both Orphan Drug and Fast Track designations for VALTOCO™. The NDA for VALTOCO™ is supported by an extensive clinical and pre-clinical package, including studies in healthy volunteers and patients with epilepsy. In the patient studies, more than 2,000 seizures have been treated to date with VALTOCO™ nasal spray.

About Neurelis

Neurelis, Inc. is a privately-held San Diego-based specialty pharmaceutical company organized to license, develop, and commercialize product candidates for epilepsy and the broader CNS market. Neurelis is leveraging its expertise in the development and commercialization of CNS compounds and strong relationships with leading researchers and clinicians in these markets to advance unique product candidates, such as VALTOCO™, to address significant unmet medical needs. For more information on the company, please visit www.neurelis.com

About Promius Pharma LLC

Promius Pharma is a wholly owned subsidiary of Dr. Reddy's Laboratories, one of the largest and most respected pharmaceutical companies in the world. With a robust commercial infrastructure and extensive research and development capabilities through its parent company, Promius Pharma is committed to bringing new products to market that meet patients' needs in dermatology and neurology. For more information, visit www.promiuspharma.com

About TOSYMRA™

Tosymra™ is an intranasal sumatriptan spray 10mg. The U.S. FDA approved Tosymra™ for the acute treatment of migraine with or without aura in adults on Jan 25, 2019. TOSYMRA™ nasal spray is formulated using a proprietary novel excipient known as Intravail® to achieve blood levels similar to a 4-mg sumatriptan subcutaneous injection, resulting in rapid onset of action. Tosymra™ is a trademark of Dr. Reddy's Laboratories.

TOSYMRA - Important Patient Safety Information:

What important information should I know about TOSYMRA?
TOSYMRA can cause serious side effects, including: heart attack and other heart problems, which may lead to death. Stop using TOSYMRA and get emergency medical help right away if you have any of the following symptoms of a heart attack:

discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw, or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded

TOSYMRA is not for people with risk factors for heart disease (high blood pressure, high cholesterol levels, smoking, overweight, diabetes, family history of heart disease) unless a heart exam is done and shows no problem.

Who should not use TOSYMRA?
Do not use TOSYMRA if you have:

heart problems or a history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
severe liver problems
hemiplegic migraines or basilar migraines. If you are not sure if you have these, ask your healthcare provider
had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your healthcare provider if you are not sure if your medicine is listed above.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the ingredients in TOSYMRA.

What should I tell my healthcare provider before taking TOSYMRA?
Tell your healthcare provider about all of your medical conditions, and about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while using TOSYMRA?
TOSYMRA can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert.

What are possible side effects of TOSYMRA?
TOSYMRA may cause serious side effects including:

changes in color or sensation in your fingers and toes (Raynaud's syndrome)
stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include: sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include: cramping and pain in your legs or hips, feeling of heaviness or tightness in your leg muscles, burning or aching pain in your feet or toes while resting, numbness, tingling, or weakness in your legs, cold feeling or color changes in 1 or both legs or feet
Increased blood pressure including a sudden severe increase (hypertensive crisis) even if you have no history of high blood pressure
medication overuse headaches. Some people who use too much migraine medicine, such as TOSYMRA, for 10 or more days each month may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with TOSYMRA.
serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using TOSYMRA, especially if TOSYMRA is used with anti-depressant medicines called SSRIs or SNRIs.
- Call your healthcare provider right away if you have any of the following: symptoms of serotonin syndrome: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures have happened in people taking sumatriptan who have never had seizures before

The most common side effects of TOSYMRA include tingling, dizziness, feeling warm or hot, burning feeling, feeling of heaviness, feeling of pressure, flushing, feeling of tightness, numbness, application site (nasal) reactions, abnormal taste, and throat irritation.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of TOSYMRA. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs. To report SUSPECTED SIDE EFFECTS, call Promius Pharma at 1-888-966-8766 or contact the FDA at 1-800-FDA-1088 (1-800-332-1088) or online at http://www.fda.gov/Safety/MedWatch

Please see Patient Information, Instructions for Use and Full Prescribing Information for TOSYMRA

What is TOSYMRA used for?
TOSYMRA is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

TOSYMRA is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines. TOSYMRA is not used to treat cluster headaches.

TOSYMRA is not used to prevent or decrease the number of migraines you have.

It is not known if TOSYMRA is safe and effective in children under 18 years of age.

For More Information:
Mark Leonard
[email protected]
847-651-9682

SOURCE Neurelis, Inc.