Upsher-Smith Laboratories Completes Acquisition Of Two Treatments For Acute Migraine In Adults


MAPLE GROVE, Minn., July 20, 2019 /PRNewswire/ — Upsher-Smith Laboratories, LLC (Upsher-Smith) as we speak introduced that it has accomplished the acquisition of Tosymra™ (sumatriptan) Nasal Spray, 10 mg, and Zembrace® SymTouch® (sumatriptan) Injection three mg from Dr. Reddy’s Laboratories Limited. The merchandise have been beforehand commercialized by Dr. Reddy’s wholly owned subsidiary, Promius Pharma LLC. Both medicines are indicated for the acute therapy of migraine with or with out aura in adults.

“More than thirty-six million Americans suffer from migraines, and Upsher-Smith is proud to be diversifying our portfolio with two products that can bring pain relief to a significant number of patients suffering from acute migraine,” stated Rusty Field, President and CEO, Upsher-Smith. “We will be working diligently to ensure the smooth delivery of Zembrace SymTouch to patients, and to prepare for the launch of Tosymra, which we expect to take place toward the end of 2019.”

The addition of Tosymra and Zembrace SymTouch rounds out Upsher-Smith’s migraine product portfolio. The Company at the moment presents Qudexy® XR (topiramate) Extended-Release Capsules, a once-daily therapy to be used within the prevention of migraine headache in adults and adolescents 12 years of age and older.  

Ballard Spahr, LLP served because the Company’s authorized counsel on this transaction.

About Migraine
Migraine is an inherited, disabling, neurological situation that results in assaults of head ache, sensitivity to the surroundings, and different neurological signs.1  It is the third most typical and the seventh most disabling medical dysfunction on the earth, affecting greater than 36 million Americans.1 Treatments for migraine embrace acute and prophylactic with the vast majority of sufferers utilizing acute remedies.2

Important Patient Safety Information Zembrace® SymTouch® (sumatriptan) Injection

What vital data ought to I find out about ZEMBRACE SymTouch? 
ZEMBRACE SymTouch could cause critical unwanted effects, together with: coronary heart assault and different coronary heart issues, which can result in loss of life. Stop utilizing ZEMBRACE SymTouch and get emergency medical assist straight away if in case you have any of the next signs of a coronary heart assault:

  • chest ache or chest discomfort that seems like an uncomfortable heavy stress, tightness or heaviness, or ache that lasts for quite a lot of minutes, or that goes away and comes again
  • ache or discomfort in your arms, again, neck, jaw, or abdomen
  • shortness of breath
  • breaking out in a chilly sweat
  • nausea or vomiting
  • feeling lightheaded

ZEMBRACE SymTouch is just not for individuals with threat elements for coronary heart illness (hypertension, excessive levels of cholesterol, smoking, obese, diabetes, household historical past of coronary heart illness) until a coronary heart examination is completed and reveals no downside.

Who shouldn’t use ZEMBRACE SymTouch?
Do not use ZEMBRACE SymTouch if in case you have:

  • coronary heart issues or a historical past of coronary heart issues
  • had a stroke, transient ischemic assaults (TIAs), or issues together with your blood circulation
  • narrowing of blood vessels to your legs or arms (peripheral vascular illness), abdomen, or kidney
  • uncontrolled hypertension
  • hemiplegic migraines (that make you unable to maneuver on one aspect of your physique) or basilar (uncommon type of migraine with aura) migraines. If you aren’t certain if in case you have these, ask your healthcare supplier
  • taken any of the next medicines within the final 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your healthcare supplier in case you are undecided in case your medication is listed above
  • extreme liver issues
  • an allergy to sumatriptan or any of the parts in ZEMBRACE SymTouch

What ought to I inform my healthcare supplier earlier than taking ZEMBRACE SymTouch?
Tell your healthcare supplier about all your medical situations, and about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements.

What ought to I keep away from whereas utilizing ZEMBRACE SymTouch?
ZEMBRACE SymTouch could cause dizziness, weak point, or drowsiness. If you could have these signs, don’t drive a automotive, use equipment, or do something the place you could be alert.

What are attainable unwanted effects of ZEMBRACE SymTouch?
ZEMBRACE SymTouch could trigger critical unwanted effects together with:

  • modifications in colour or sensation in your fingers and toes (Raynaud’s syndrome)
  • abdomen and intestinal issues (gastrointestinal and colonic ischemic occasions)
  • issues with blood circulation to your legs and toes (peripheral vascular ischemia)
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • remedy overuse complications. Some individuals who use too many ZEMBRACE SymTouch injections could have worse complications (remedy overuse headache)
  • serotonin syndrome. Serotonin syndrome is a uncommon however major problem that may occur in individuals utilizing ZEMBRACE SymTouch, particularly if used with antidepressant medicines
    • Call your healthcare supplier straight away if in case you have any of the next: signs of serotonin syndrome: psychological modifications resembling seeing issues that aren’t there (hallucinations), agitation, or coma; quick heartbeat; modifications in blood stress; excessive physique temperature; tight muscle mass; bother strolling; or nausea, vomiting, or diarrhea
  • critical allergic reactions. Get medical assist straight away if in case you have any of those signs of a critical allergic response: swelling of your face, lips, mouth, or tongue; bother respiration; wheezing; extreme itching; pores and skin rash, redness, or swelling; dizziness or fainting; quick heartbeat or pounding in your chest; or sweating
  • Seizures have occurred in individuals taking sumatriptan who’ve by no means had seizures earlier than

The most typical unwanted effects of ZEMBRACE SymTouch embrace ache and redness at your injection website; tingling or numbness in your fingers or toes; dizziness; heat scorching burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or drained.

These should not all of the attainable unwanted effects of ZEMBRACE SymTouch. For extra data, ask your healthcare supplier or pharmacist. You are inspired to report unfavourable unwanted effects of pharmaceuticals. To report SUSPECTED SIDE EFFECTS, name Promius Pharma at 1-888-966-8766 or contact the FDA at 1-800-FDA-1088 (1-800-332-1088) or on-line at http://www.fda.gov/Safety/MedWatch

INDICATION AND USAGE

What is ZEMBRACE SymTouch used for?
ZEMBRACE SymTouch is a prescription medication used to deal with acute migraine complications with or with out aura in adults who’ve been recognized with migraine.
ZEMBRACE SymTouch is just not used to stop or lower the variety of migraines you could have. It is just not recognized if ZEMBRACE SymTouch is secure and efficient in kids beneath 18 years of age.

Please see Patient Information, Instructions For Use and Full Prescribing Information for ZEMBRACE SymTouch or go to www.zembrace.com.

Important Patient Safety Information for Tosymra™ (sumatriptan) Nasal Spray

What vital data ought to I find out about TOSYMRA?

TOSYMRA could cause critical unwanted effects, together with: coronary heart assault and different coronary heart issues, which can result in loss of life. Stop utilizing TOSYMRA and get emergency medical assist straight away if in case you have any of the next signs of a coronary heart assault:

  • discomfort within the heart of your chest that lasts for quite a lot of minutes, or that goes away and comes again
  • extreme tightness, ache, stress, or heaviness in your chest, throat, neck, or jaw
  • ache or discomfort in your arms, again, neck, jaw, or abdomen
  • shortness of breath with or with out chest discomfort
  • breaking out in a chilly sweat
  • nausea or vomiting
  • feeling lightheaded

TOSYMRA is just not for individuals with threat elements for coronary heart illness (hypertension, excessive levels of cholesterol, smoking, obese, diabetes, household historical past of coronary heart illness) until a coronary heart examination is completed and reveals no downside.

Who shouldn’t use TOSYMRA?

Do not use TOSYMRA if in case you have:

  • coronary heart issues or a historical past of coronary heart issues
  • narrowing of blood vessels to your legs, arms, abdomen, or kidney (peripheral vascular illness)
  • uncontrolled hypertension
  • extreme liver issues
  • hemiplegic migraines or basilar migraines. If you aren’t certain if in case you have these, ask your healthcare supplier
  • had a stroke, transient ischemic assaults (TIAs), or issues together with your blood circulation
  • taken any of the next medicines within the final 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your healthcare supplier in case you are undecided in case your medication is listed above
  • are taking sure antidepressants, often called monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or much less because you stopped taking a MAO-A inhibitor. Ask your healthcare supplier or pharmacist for a listing of those medicines in case you are undecided.
  • an allergy to sumatriptan or any of the elements in TOSYMRA.

What ought to I inform my healthcare supplier earlier than taking TOSYMRA?
Tell your healthcare supplier about all your medical situations, and about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements.

What ought to I keep away from whereas utilizing TOSYMRA?
TOSYMRA could cause dizziness, weak point, or drowsiness. If you could have these signs, don’t drive a automotive, use equipment, or do something the place you could be alert.

What are attainable unwanted effects of TOSYMRA?
TOSYMRA could trigger critical unwanted effects together with:

  • modifications in colour or sensation in your fingers and toes (Raynaud’s syndrome)
  • abdomen and intestinal issues (gastrointestinal and colonic ischemic occasions). Symptoms of gastrointestinal and colonic ischemic occasions embrace: sudden or extreme abdomen ache, abdomen ache after meals, weight reduction, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
  • issues with blood circulation to your legs and toes (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia embrace: cramping and ache in your legs or hips, feeling of heaviness or tightness in your leg muscle mass, burning or aching ache in your toes or toes whereas resting, numbness, tingling, or weak point in your legs, chilly feeling or colour modifications in 1 or each legs or toes
  • Increased blood stress together with a sudden extreme improve (hypertensive disaster) even if in case you have no historical past of hypertension
  • remedy overuse complications. Some individuals who use an excessive amount of migraine medication, resembling TOSYMRA, for 10 or extra days every month could have worse complications (remedy overuse headache). If your complications worsen, your healthcare supplier could resolve to cease your therapy with TOSYMRA.
  • serotonin syndrome. Serotonin syndrome is a uncommon however major problem that may occur in individuals utilizing TOSYMRA, particularly if TOSYMRA is used with anti-depressant medicines referred to as SSRIs or SNRIs.
    • Call your healthcare supplier straight away if in case you have any of the next: signs of serotonin syndrome: psychological modifications resembling seeing issues that aren’t there (hallucinations), agitation, or coma; quick heartbeat; modifications in blood stress; excessive physique temperature; tight muscle mass; or bother strolling
  • hives (itchy bumps); swelling of your tongue, mouth, or throat
  • seizures have occurred in individuals taking sumatriptan who’ve by no means had seizures earlier than

The most typical unwanted effects of TOSYMRA embrace tingling, dizziness, feeling heat or scorching, burning feeling, feeling of heaviness, feeling of stress, flushing, feeling of tightness, numbness, software website (nasal) reactions, irregular style, and throat irritation.

Tell your healthcare supplier if in case you have any aspect impact that bothers you or that doesn’t go away. These should not all of the attainable unwanted effects of TOSYMRA. For extra data, ask your healthcare supplier or pharmacist.

You are inspired to report unfavourable unwanted effects of pharmaceuticals. To report SUSPECTED SIDE EFFECTS, name Promius Pharma at 1-888-966-8766 or contact the FDA at 1-800-FDA-1088 (1-800-332-1088) or on-line 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 medication used to deal with acute migraine complications with or with out aura in adults.

TOSYMRA is just not used to deal with different sorts of complications resembling hemiplegic (that make you unable to maneuver on one aspect of your physique) or basilar (uncommon type of migraine with aura) migraines. TOSYMRA is just not used to deal with cluster complications.

TOSYMRA is just not used to stop or lower the variety of migraines you could have. It is just not recognized if TOSYMRA is secure and efficient in kids beneath 18 years of age.

Important Patient Safety Information for Qudexy® XR (topiramate) Extended-Release Capsules

WHAT IS QUDEXY XR?

Qudexy® XR (topiramate) Extended-Release Capsules is a prescription medication used:

  • To forestall migraine complications in adults and adolescents 12 years and older.
  • To deal with sure sorts of seizures (partial-onset seizures and first generalized tonic-clonic seizures) in adults and kids 2 years and older.
  • With different medicines to deal with sure sorts of seizures (partial-onset seizures, major generalized tonic-clonic seizures, and seizures related to Lennox-Gastaut syndrome) in adults and kids 2 years and older.

WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW?

Qudexy XR could cause critical unwanted effects, together with:

  • Serious eye issues, which can embrace blurred or sudden lower in imaginative and prescient, eye ache and redness or a blockage of fluid which will trigger elevated stress within the eye (secondary angle closure glaucoma). If left untreated, this may result in everlasting imaginative and prescient loss.
  • Decreased sweating and fever. People, particularly kids, needs to be watched for indicators of decreased sweating and fever, particularly in scorching temperatures. Some individuals could have to be hospitalized for this situation.
  • Increased acid degree within the blood (metabolic acidosis). This could or could not trigger signs. Symptoms could embrace feeling drained, decreased urge for food, change in heartbeat, or bother considering clearly. If left untreated, metabolic acidosis could cause brittle or mushy bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can sluggish the speed of development in kids, and should probably hurt the unborn baby of pregnant sufferers.
  • High blood ammonia ranges. High ammonia within the blood can have an effect on psychological actions, sluggish alertness and trigger tiredness or vomiting. This may also occur when Qudexy XR is taken with a drugs referred to as valproic acid (e.g., Depakene® and Depakote®).
  • Kidney stones. Drink loads of fluids when taking Qudexy XR to lower your possibilities of getting kidney stones.
  • Low physique temperature. Taking Qudexy XR when you’re additionally taking valproic acid could trigger a drop in physique temperature to lower than 95°F, tiredness, confusion, or coma.
  • Effects on considering and application. Qudexy XR could have an effect on the way you assume, and might trigger confusion, issues with focus, consideration, reminiscence, or speech. Qudexy XR could trigger despair or temper issues, tiredness, and sleepiness.
  • Dizziness or lack of muscle coordination.

Call your healthcare supplier straight away if in case you have any of the above signs.

Like different antiepileptic medication, Qudexy XR could trigger suicidal ideas or actions in a really small variety of individuals, about 1 in 500. Before taking Qudexy XR, inform your healthcare supplier if in case you have or have had despair, temper issues, or suicidal ideas or habits.  Call a healthcare supplier straight away if in case you have: ideas about suicide or dying; try to commit suicide; have new or worsening despair or nervousness; really feel agitated or stressed; expertise panic assaults, have bother sleeping (insomnia); have new or worsening irritability; really feel or act aggressive, indignant, or violent; act on harmful impulses; expertise an excessive improve in exercise and speaking (mania); or different uncommon modifications in your habits or temper.

Qudexy XR can hurt your unborn child. All ladies of childbearing age ought to discuss to their healthcare supplier about attainable various remedies. If you’re taking Qudexy XR throughout being pregnant, your child has a better threat for start defects referred to as cleft lip and cleft palate. These defects can start early in being pregnant, even earlier than you’re pregnant. Also, for those who take Qudexy XR throughout being pregnant, your child could also be smaller than anticipated at start; the long-term results of this should not recognized. If the choice is made to make use of Qudexy XR, it’s best to use efficient contraception (contraception).Tell your healthcare supplier straight away for those who grow to be, or plan to grow to be pregnant whereas taking Qudexy XR.

The most typical unwanted effects of Qudexy XR embrace: tingling of the legs and arms (paresthesia), not feeling hungry, weight reduction, nervousness, nausea, speech issues, tiredness, dizziness, sleepiness/drowsiness, a change in the best way meals style, higher respiratory tract an infection, decreased feeling or sensitivity particularly within the pores and skin, sluggish reactions, problem with reminiscence, fever, irregular imaginative and prescient, diarrhea, and ache within the stomach. These should not all of the attainable unwanted effects of Qudexy XR. For extra data, ask your healthcare supplier or pharmacist.

Before taking Qudexy XR, inform your healthcare supplier about all your medical situations, together with for those who: have had despair, temper issues, or suicidal ideas or habits; have kidney issues, kidney stones, or are getting kidney dialysis; have a historical past of metabolic acidosis (an excessive amount of acid within the blood); have liver issues; have weak, brittle or mushy bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density); have lung or respiration issues; have eye issues, particularly glaucoma; have diarrhea; have a development downside; are on a weight loss plan excessive in fats and low in carbohydrates, which known as a ketogenic weight loss plan; are having surgical procedure; are pregnant or planning to grow to be pregnant; or in case you are breastfeeding.  The medication in Qudexy XR (topiramate) passes into your breast milk.  It is just not recognized if the drugs, topiramate, that passes into breast milk can hurt your child.  Talk together with your healthcare supplier about the easiest way to feed your child for those who take Qudexy XR.

Tell your healthcare supplier about all of the medicines you’re taking, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements.  Especially inform your healthcare supplier for those who take metformin (e.g., Glucophage); valproic acid (e.g., Depakene or Depakote); any medicines that impair or lower your considering, focus, or muscle coordination; contraception drugs (Qudexy XR could make contraception drugs much less efficient); medicines used to stop seizures; or every other carbonic anhydrase inhibitors (e.g., zonisamide or acetazolamide). 

Do not cease Qudexy XR with out first speaking to a healthcare supplier. If you could have epilepsy and also you cease taking Qudexy XR out of the blue, you might have seizures that don’t cease. Your healthcare supplier will inform you easy methods to cease taking Qudexy XR slowly.

Do not drink alcohol whereas taking Qudexy XR. Qudexy XR and alcohol could cause unwanted effects resembling sleepiness and dizziness.

Do not drive a automotive, swim, climb, or function heavy equipment till you understand how Qudexy XR impacts you. Qudexy XR can sluggish your considering and motor abilities, and should have an effect on imaginative and prescient. Even when taking Qudexy XR, some sufferers with epilepsy will proceed to have unpredictable seizures.

This is an important data to find out about Qudexy XR however is just not complete.   For extra data, discuss to your healthcare supplier and skim the Medication Guide for Qudexy XR. You may also go to www.upsher-smith.com or name 1-888-650-3789.

You are inspired to report unfavourable unwanted effects of pharmaceuticals to the FDA. Visit www.fda.gov/medwatch or name 1-800-FDA-1088.

About Upsher-Smith
Upsher-Smith Laboratories, LLC is a trusted U.S. pharmaceutical firm that strives to enhance the well being and lives of sufferers by an unwavering dedication to high-quality merchandise and sustainable development. Since 1919, it has introduced generics and types to a wide selection of shoppers backed by an attentive degree of service, robust business relationships, and dedication to uninterrupted provide.        

As Upsher-Smith celebrates its 100-year anniversary, the corporate enters a brand new bold period that has been accelerated by its 2017 acquisition by Sawai Pharmaceutical Co., Ltd. Upsher-Smith and Sawai plan to leverage one another for development worldwide and embark on an thrilling new chapter as they search to ship the very best worth for his or her stakeholders, and most significantly, Do More Good™ for the sufferers they serve. For extra data, go to www.upsher-smith.com.

About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY,NYSE: RDY) is an built-in pharmaceutical firm, dedicated to offering reasonably priced and progressive medicines for more healthy lives. Through its three companies – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s presents a portfolio of services together with APIs, customized pharmaceutical companies, generics, biosimilars and differentiated formulations. Our main therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, ache administration and dermatology. Dr. Reddy’s operates in markets throughout the globe. Our main markets embrace – USA, India, Russia & CIS international locations, and Europe. For extra data, go surfing to: www.drreddys.com.

About Promius Pharma LLC
Promius Pharma is a wholly-owned subsidiary of Dr. Reddy’s Laboratories, one of many largest and most revered pharmaceutical corporations on the earth. Promius Pharma is dedicated to bringing new merchandise to market that meet sufferers’ wants. For extra data, go surfing to: www.promiuspharma.com.

Qudexy is a registered trademark of Upsher-Smith Laboratories, LLC.
All different marks are the property of their respective homeowners.

  1. American Migraine Foundation. Available at: https://americanmigrainefoundation.org/resource-library/migraine-where-we-are-and-where-we-are-going/. Accessed June 17, 2019.
  2. Decision Resources Group Report, Symphony Migraine Patient Claims Data. 2015. IMS Database.

PM-000280.01 

SOURCE Upsher-Smith Laboratories, LLC

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