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Dr. Reddys Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) and its subsidiary Promius Pharma, LLC announced today the approval of TOSYMRA (formerly known as DFN-02) by the FDA (Food and Drug Administration)). TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults. TOSYMRA is the latest product added to Promius Pharma's acute migraine portfolio. The company is working on the commercialization of this product.
We are delighted with TOSYMRA's approval. This approval confirms our ability to develop well-differentiated products to meet the unmet needs of migraine patients and healthcare professionals who treat them, said G.V. Prasad, Co-President and Chief Executive Officer, Dr. Reddys Laboratories.
According to Dr. Anil Namboodiripad, PhD, President of Promius Pharma, TOSYMRA Nasal Spray is formulated with the help of a new proprietary excipient called Intravail. achieve blood levels similar to those of a subcutaneous injection of sumatriptan 4 mg, resulting in a rapid onset of action. Independent research shows that 26% to 40% of migraine patients are not optimally controlled with their current treatment.1 For patients who are suffering the debilitating and disruptive effects of migraine, there is still a need for reliable and effective treatment options. At Promius, we are committed to developing new ways to improve patient experiences. TOSYMRA is a fog-like nasal spray that works quickly and is well tolerated.
Important information on patient safety:
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What important information should I know about TOSYMRA?
TOSYMRA can cause serious side effects, including heart attack and other heart problems that can lead to death. Stop using TOSYMRA and get immediate emergency medical help if you have any of the following symptoms of a heart attack:
- discomfort in the center of the chest that lasts more than a few minutes or goes back and forth
- severe oppression, pain, pressure or heaviness in the chest, throat, neck or jaw
- pain or discomfort in the arms, back, neck, jaw or stomach
- shortness of breath with or without chest discomfort
- go out in cold sweats
- nausea or vomiting
- feel dizzy
TOSYMRA is not intended for people with risk factors for heart disease (high blood pressure, high cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a cardiac examination does not realized and shows no problem.
Who should not use TOSYMRA?
Do not use TOSYMRA if you have:
- heart problems or history of heart problems
- narrowing of blood vessels in the legs, arms, stomach or kidneys (peripheral vascular disease)
- uncontrolled hypertension
- severe liver problems
- hemiplegic migraines or basilar migraine. If you are unsure of having them, ask your health care provider
- had a stroke, transient ischemic attack (TIA) or blood circulation problems
- taken any of the following within the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines or dihydroergotamine. Ask your health care provider if you are unsure whether your medicine is listed above.
- take certain antidepressants, called monoamine oxidase inhibitors (MAO) -A, or 2 weeks or less have pbaded since you stopped taking a MAO-A inhibitor. If in doubt, ask your health care provider or pharmacist for a list of these medications.
- is allergic to sumatriptan or to any of the ingredients of TOSYMRA.
What should I tell my health care provider before taking TOSYMRA?
Talk to your health care provider about all of your medical conditions and all the medications you are taking, including prescription and over-the-counter medications, vitamins, and herbal supplements.
What should I avoid using TOSYMRA?
TOSYMRA may cause dizziness, weakness or drowsiness. If you experience these symptoms, do not drive, operate machinery, or do anything that requires mental alertness.
What are the possible side effects of TOSYMRA?
TOSYMRA may cause serious side effects, including:
- changes in color or sensation in the fingers and toes (Raynauds syndrome)
- gastric and intestinal problems (gastrointestinal events and ischemic colic). Symptoms of gastrointestinal and colonic ischemic events include: sudden or severe abdominal pain, abdominal pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
- blood circulation problems in the legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include: cramps and pain in the legs or hips, feeling of heaviness or contraction of the leg muscles, burning or painful pain in the feet or toes at rest, numbness, tingling or weakness in the legs, feeling cold or changes color in 1 or both legs or feet
- Increased blood pressure, including a sudden and severe increase (hypertensive crisis), even if you do not have a history of high blood pressure
- overuse of medications Some people who use too many migraine medications, such as TOSYMRA, for 10 days or more a month may have more severe headaches (drug abuse headache). If your headaches worsen, your health care provider may decide to discontinue your treatment with TOSYMRA.
- serotonin syndrome. Serotonin syndrome is a rare but serious problem that can occur in people who use TOSYMRA, especially if TOSYMRA is used with antidepressants called SSRIs or IRSNs.
- Call your health care provider immediately if you have any of the following: symptoms of serotonin syndrome: mental changes such as seeing things absent (hallucinations), agitation or coma; rapid pulse; changes in blood pressure; high body temperature; tense muscles; or trouble walking
- hives (itching); swelling of the tongue, mouth or throat
- seizures occurred in people taking sumatriptan and who had never had seizures before
The most common side effects of TOSYMRA are: tingling, dizziness, feeling of warmth, burning sensation, feeling of heaviness, feeling of pressure, hot flashes, feeling of tightness, feeling numb, application site reactions (nasal), abnormal taste and irritation of the throat.
Tell your health care provider if you have a side effect that bothers you or does not go away. These are not all the possible side effects of TOSYMRA. For more information, ask your health care provider or pharmacist.
We encourage you to report the negative side effects of prescription drugs. To report suspected adverse reactions, call Promius Pharma at 1-888-966-8766 or contact the FDA at 1-800-FDA-1088 (1-800-332-1088) or online at the address http://www.fda.gov/Safety/MedWatch.
Please refer to TOSYMRA patient information, usage instructions and complete dosing information.
Why is TOSYMRA used?
TOSYMRA is a prescription medicine used to treat acute migraines with or without aura in adults.
TOSYMRA is not used to treat other types of headaches such as hemiplegics (which prevent you from moving to one side of your body) or basilar migraines (a rare form of migraine with will have). TOSYMRA is not used to treat cluster headache.
TOSYMRA is not used to prevent or reduce the number of migraines you have.
It is not known if TOSYMRA is safe and effective in children under 18 years old.
About Intravail
Intravail is a registered trademark of Neurelis, Inc. Intravail The drug delivery technology allows the non-invasive delivery of a wide range of protein, peptide and non-peptide drugs (up to 30,000 daltons in size) that can currently be administered only by injection. Intravail can be used by the oral, oral, dermal and intranasal routes of drug administration.
Reference: 1. Pavlovic JM, DC Hawk, ML Reed, et al. Use and discontinuation of the triptan in a population sample of migraine sufferers: Results of the Migraine in America Symptoms and Treatment (MIP) study. Presented at the 60th Annual Scientific Meeting of the American Headache Society; June 28, 2018; San Francisco, CA.
TOY-0119-006
About Dr. Reddys: Dr. Reddys Laboratories Ltd. (ESB: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for a healthier life. Through its three activities: Pharmaceutical Services and Active Ingredients, Global Generic Products and Proprietary ProductsDr. Reddys offers a portfolio of products and services including APIs, customized pharmaceutical services, generics, biosimilars and differentiated formulations. Our main therapeutic areas are gastroenterology, cardiology, diabetology, oncology, pain management and dermatology. Mr. Reddys operates in markets around the world. Our main markets include the United States, India, Russia and the CIS countries, as well as Europe. For more information, log on to: www.drreddys.com.
About Promius Pharma LLC
Promius Pharma is a wholly owned subsidiary of Dr. Reddys Laboratories, one of the largest and most respected pharmaceutical companies in the world. With a solid commercial infrastructure and extensive research and development capabilities through its parent company, Promius Pharma is committed to commercializing new products that meet the needs of patients in dermatology and neurology. For more information, visit www.promiuspharma.com.
Warning: This press release may include statements of future expectations and other forward-looking statements that are based on management's current views and badumptions and involve known or unknown uncertainties and risks that could cause the results to differ materially, performance or actual events and those expressed in such statements. In addition to forward-looking statements because of their context, the words "may", "will", "should", "expect", "anticipate", "intend", "anticipate", "believe" "," Estimates "," predicts "," potential "or" continue "and similar expressions refer to forward-looking statements. Actual results, performances or events may differ materially from those presented in these statements for non-restrictive reasons, including: loss events, (ii) mortality and morbidity levels and trends, (iii) changes in levels competition and general competition factors, (iv) changes in legislation and regulation and policies of central banks and / or governments, (v) impact of acquisitions or reorganizations, including integration issues related.
The company badumes no obligation to update the information contained in this document.
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