Upsher-Smith To Present New Data On Qudexy® XR (topiramate) Extended-Release Capsules And USL261 (Investigational Intranasal Midazolam)

Data to be Highlighted at the 69th Annual Meeting of the American Epilepsy Society

23 Nov, 2015, 09:00 ET from Upsher-Smith Laboratories, Inc.

PHILADELPHIA, Nov. 23, 2015 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (Upsher-Smith) today announced that it will present nine posters at the 69th Annual Meeting of the American Epilepsy Society (AES), including new data analyses on USL261 (intranasal midazolam), a novel, investigational midazolam formulation specifically designed for intranasal delivery, and Phase 3 data on Qudexy® XR (topiramate) extended-release capsules.  Additionally, results from the first-of-its-kind, landmark Seizure Cluster Burden of Illness survey, conducted online by Harris Poll in September 2014 on behalf of The Epilepsy Foundation and Upsher-Smith, will be presented. The AES meeting will take place in Philadelphia, December 4-8, 2015.

"Upsher-Smith is committed to improving people's lives, especially the lives of those impacted by seizure disorders," said William Pullman, MB, BS, BMedSc, PhD, FRACP, Chief Scientific Officer and Biotech Research Institute Division President, Upsher-Smith.  "This will also mark the first time that comprehensive findings from the Seizure Cluster Burden of Illness survey will be presented.  It is our hope that the findings from the survey will help educate the broader medical community about unmet needs in seizure cluster care.  We are also pleased to be presenting a number of posters that feature data from our epilepsy portfolio, including data supporting the development of intranasal midazolam."

Scientific posters from Upsher-Smith slated for presentation at AES include: 

USL261

Tolerability and Pharmacodynamics of Midazolam Nasal Spray (USL261) in Healthy Geriatric and Non-Geriatric Adults 
Poster 2.259; Sunday, December 6, 2015; 8 a.m. - 4 p.m. EST 
Authors to present 12 p.m. to 2 p.m.

Pharmacokinetics of Midazolam Nasal Spray (USL261) in Healthy Geriatric and Non-Geriatric Adults 
Poster 2.256; Sunday, December 6, 2015; 8 a.m. - 4 p.m. EST
Authors to present 12 p.m. to 2 p.m.

Qudexy® XR

Development of Unique Dosage Form and Differentiating Features of USL255, Qudexy® XR (Topiramate) Extended-Release Capsules 
Poster 3.257; Monday, December 7, 2015; 8 a.m. - 2 p.m. EST
Authors to present 12 p.m. to 2 p.m.

Neurocognitive Adverse Event Profile of USL255 (Qudexy® XR; Topiramate Extended-Release Capsules): Phase 3 PREVAIL and PREVAIL OLE Studies 
Poster 3.258; Monday, December 7, 2015; 8 a.m. - 2 p.m. EST
Authors to present 12 p.m. to 2 p.m.

Long-Term Efficacy of USL255 (Qudexy® XR; Topiramate Extended-Release Capsules) by Refractory Status and Age: PREVAIL OLE 
Poster 3.259; Monday, December 7, 2015; 8 a.m.2 p.m. EST
Authors to present 12 p.m. to 2 p.m.

Seizure Cluster Burden of Illness Harris Poll Survey

Comparing Perceptions of the Impact of Seizure Clusters Among Clinicians, Patients, and Caregivers 
Poster 1.328; Saturday, December 5, 2015; 12 p.m. - 6 p.m. EST
Authors to present 12 p.m. to 2 p.m.

The Patient-Clinician Relationship in Seizure Cluster Management 
Poster 1.329; Saturday, December 5, 2015; 12 p.m. - 6 p.m. EST
Authors to present 12 p.m. to 2 p.m.

Burden of Seizure Clusters on Patients with Epilepsy and Caregivers 
Poster 1.330; Saturday, December 5, 2015; 12 p.m. - 6 p.m. EST
Authors to present 12 p.m. to 2 p.m.

Other

Attitudes Toward Rescue Medications and Discussion of Seizure Emergencies Among Physicians, Patients, and Caregivers 
Poster 1.327; Saturday, December 5, 2015; 12 p.m. - 6 p.m. EST
Authors to present 12 p.m. to 2 p.m.

Abstracts of the poster presentations can be found online at www.aesnet.org. To schedule an interview with an investigator, please contact Andrea Preston at apreston@klcpr.com.

About Epilepsy 
Epilepsy is a medical condition that is characterized by recurrent seizures.  More than two million people in the U.S. are estimated to be affected by epilepsy, with about 150,000 new cases of epilepsy diagnosed each year.1  Epilepsy can be associated with profound physical, psychological and social consequences that negatively impact people's lives.

About Seizure Clusters
Seizure clusters, also referred to as acute repetitive seizures, seizure flurries, crescendo seizures, cluster seizures, or bouts of increased seizure activity, consist of multiple seizures which occur over a relatively brief period of time with a pattern distinguishable from the patient's usual seizure pattern.2  

Reports of seizure cluster prevalence vary depending on the population evaluated.  Seizure clusters have been associated with worse seizure control.3  In a study conducted in a tertiary epilepsy center in patients with a broad range of seizure control, the prevalence of seizure clusters was close to 30%.3  The number of patients with epilepsy in the United States who experience seizure clusters has been estimated to be 152,000.4,5,6,7  

About the Seizure Cluster Burden of Illness Survey
The Seizure Cluster Burden of Illness survey was conducted online in the United States by Harris Poll on behalf of The Epilepsy Foundation with unrestricted grant support from Upsher-Smith Laboratories, Inc. from September 2-30, 2014, among 861 adults ages 18 and older, including: 259 patients, 263 caregivers of adult or pediatric patients, and 339 neurologists. Raw data were weighted as needed to achieve representativeness within the respective respondent populations. This online survey is not based on a probability sample and therefore no estimate of theoretical sampling error can be calculated.  For complete survey methodology, including weighting variables and subgroup sample sizes, please contact Andrea Preston at Kovak-Likly Communications at 203-762-8833, apreston@klcpr.com.

INDICATIONS

Qudexy® XR (topiramate) Extended-Release Capsules is a prescription medicine used to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) and with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about Qudexy XR?

You should discuss the potential benefits and risks of Qudexy XR with your doctor.   

Qudexy XR may cause serious eye problems that can lead to permanent loss of vision if not treated. You should call your doctor right away if you have any new eye symptoms, including any new problems with your vision. Qudexy XR may cause decreased sweating and fever, which you should monitor and call your doctor right away if you have a high fever, a fever that does not go away, or decreased sweating develops. Qudexy XR can increase the level of acid in your blood (metabolic acidosis), which can lead to complications if left untreated. Your doctor should do a blood test to measure the level of acid in your blood before and during your treatment with Qudexy XR. Do not take Qudexy® XR if you have been told you have a problem with your blood called metabolic acidosis and are taking a medicine called metformin at the same time.

What should I tell my doctor BEFORE starting Qudexy XR?

Before taking Qudexy XR, tell your doctor about all of your medical conditions, including if you:

  • have had depression, mood problems, or suicidal thoughts or behavior;
  • have kidney problems, kidney stones, or are getting kidney dialysis;
  • have a history of metabolic acidosis (too much acid in the blood);
  • have liver problems;
  • have weak, brittle or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density);
  • have lung or breathing problems;
  • have eye problems, especially glaucoma;
  • have diarrhea;
  • have a growth problem;
  • are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet;
  • are having surgery; are pregnant or plan to become pregnant;
  • or if you are breastfeeding. The medicine in Qudexy XR (topiramate) passes into your breast milk. It is not known if the medicine, topiramate, that passes into breast milk can harm your baby. Talk to your doctor about the best way to feed your baby if you take Qudexy XR.

Also tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take metformin (e.g., Glucophage); valproic acid (e.g., Depakene or Depakote); any medicines that impair or decrease your thinking, concentration, or muscle coordination; birth control pills; medicines used to prevent seizures; or any other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide, or dichlorphenamide). Qudexy XR may make your birth control pills less effective. Ask your doctor if you are not sure if your medicine is listed above.

What should I watch for AFTER starting Qudexy XR? 

Qudexy XR can cause serious side effects, including:

  • Eye problems. Serious eye problems include blurred vision, sudden decrease in vision with or without eye pain and redness, and a blockage of fluid that may cause increased pressure in the eye (secondary angle closure glaucoma). If left untreated, these can lead to permanent vision loss.
  • Decreased sweating and fever. People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition.
  • Increased acid level in your blood (metabolic acidosis). This may or may not cause symptoms. Symptoms may include feeling tired, decreased appetite, change in heartbeat, or trouble thinking clearly. If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may harm your baby if you are pregnant.
  • High blood ammonia levels. High ammonia in the blood can affect mental activities, slow alertness, cause tiredness, or cause vomiting. This can also happen when Qudexy XR is taken with a medicine called valproic acid (e.g., Depakene® and Depakote®).
  • Kidney stones. Drink plenty of fluids when taking Qudexy XR to decrease your chances of getting kidney stones.
  • Low body temperature. Taking Qudexy XR when you are also taking valproic acid may cause a drop in body temperature to less than 95°F, tiredness, confusion, or coma.
  • Effects on thinking and alertness. Qudexy XR may affect how you think, and can cause confusion, and problems with concentration, attention, memory, or speech. Qudexy XR may cause depression or mood problems, tiredness, and sleepiness.
  • Dizziness or loss of muscle coordination.

Call your doctor right away if you have any of the above symptoms.

The most common side effects of Qudexy XR include: tingling of the arms and legs (paresthesia), not feeling hungry, weight loss, nervousness, speech problems, tiredness, dizziness, sleepiness/drowsiness, slow reactions, difficulty with memory, fever, and abnormal vision. These are not all the possible side effects of Qudexy XR. For more information, ask your doctor or pharmacist.

Like other antiepileptic drugs, Qudexy XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a doctor right away if you have any of these symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying;
  • attempts to commit suicide;
  • new or worse depression or anxiety;
  • feel agitated or restless;
  • experience panic attacks;
  • trouble sleeping (insomnia);
  • new or worse irritability;
  • feel or act aggressive, angry, or violent;
  • act on dangerous impulses;
  • an extreme increase in activity and talking (mania);
  • other unusual changes in behavior or mood.

Qudexy XR can harm your unborn baby. All women of childbearing age should talk to their doctors about possible alternative treatments. If you take Qudexy XR during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. If the decision is made to use Qudexy XR, you should use effective birth control (contraception) unless you are planning to become pregnant. Tell your doctor right away if you become pregnant while taking Qudexy XR.

Do not stop Qudexy XR without first talking to a doctor. If you have epilepsy and you stop taking Qudexy XR suddenly, you may have seizures that do not stop. Your doctor will tell you how to stop taking Qudexy XR slowly.

What should I avoid while taking Qudexy XR?

Do not drink alcohol while taking Qudexy XR. Qudexy XR and alcohol can cause serious side effects such as severe sleepiness and dizziness and an increase in seizures.

Do not drive a car, swim, climb, or operate heavy machinery until you know how Qudexy XR affects you. Qudexy XR can slow your thinking and motor skills, and may affect vision. Even when taking Qudexy XR, some patients with epilepsy will continue to have unpredictable seizures.

How should I take Qudexy XR?

Take Qudexy XR exactly as your doctor tells you to. You may swallow Qudexy XR capsules whole or, if you cannot swallow the capsule whole, you may carefully open the Qudexy XR capsule and sprinkle the medicine on a spoonful of soft food like applesauce. Swallow the food and medicine mixture right away. Do not store the food and medicine mixture to use later or crush or chew the food and medicine mixture before swallowing.

This is the most important information to know about Qudexy XR. For more information, talk to your health care provider and read the Medication Guide for Qudexy XR. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information at www.QudexyXR.com

Qudexy is a registered trademark of Upsher-Smith Laboratories, Inc.
All other marks are the property of their respective owners.

About Upsher-Smith
Upsher-Smith Laboratories, Inc., founded in 1919, is a growing, fully integrated pharmaceutical company dedicated to its mission of delivering high-value, high-quality therapies and solutions which measurably improve individuals' lives.  As a family-owned pharmaceutical company, we are able to adapt and thrive in a dynamic healthcare environment.  Our world is constantly evolving, and we are continually adapting to the ever-changing needs of patients, physicians, pharmacists, and healthcare organizations.  Where there is a need, we will work to deliver solutions that simplify access to treatment, deliver better health outcomes, and enhance life.  Upsher-Smith has a particular focus on developing therapies for people living with central nervous system (CNS) conditions, such as seizure disorders.  For more information, visit www.upsher-smith.com.

References

1.     Epilepsy.com. Available at: http://www.epilepsy.com/learn/epilepsy-statistics.  Accessed October 27, 2015.

2.     Dreifuss FE, Rosman NP, Cloyd JC, et al. A comparison of rectal diazepam gel and placebo for acute repetitive seizures. N Engl J Med. 1998;338:1869-75.

3.     Haut SR, Shinnar S, and Moshe SL. Seizure Clustering: Risks and Outcomes.  Epilepsia.  2005;46(1):146-149.

4.     Kobau R, Zahran H, Thurman DJ, et al. Epilepsy Surveillance Among Adults – 19 States, Behavioral Risk Factor Surveillance System, 2005.  MMWR.  2008;57:SS-6.

5.     Kwan P, Brodie MJ. Early Identification of Refractory Epilepsy. N Engl J Med. 2000;342:314-319.

6.     Berg AT, Vickrey BG, Testa FM, et al. How long does it take for epilepsy to become intractable? A prospective investigation. Annals of Neurology. 2006;60:73-79.

7.     Haut SR, Lipton RB, LeValley AJ, et al. Identifying seizure clusters in patients with epilepsy. Neurology. 2005 October 25;65(8):1313-1315.

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