Dr. Reddy’s Laboratories and its U.S. subsidiary, Promius Pharma, announced U.S. FDA approval on January 28 for its migraine treatment TOSYMRA™ in the United States
| SAN DIEGO, Jan. 30, 2018 /PRNewswire/ -- Neurelis announced today that its Intravail® licensing partner, Dr. Reddy’s Laboratories, Inc. 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:
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 VATOCO™. 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 intrasanal 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 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?
What should I tell my healthcare provider before taking TOSYMRA? What should I avoid while using TOSYMRA? What are possible side effects of TOSYMRA?
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 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:
SOURCE Neurelis, Inc. |
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