UPSHER-SMITH TO FEATURE MULTIPLE PRESENTATIONS AT THE AMERICAN EPILEPSY SOCIETY (AES) 2024 ANNUAL MEETING

News provided by

Dec 02, 2024, 13:29 ET

MAPLE GROVE, Minn., Dec. 2, 2024 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced its participation at AES 2024, the Annual Meeting of the American Epilepsy Society, from December 6-10, 2024 in Los Angeles, California, where it will present a range of events, including Innovation Pavilion presentations and two scientific posters featuring new data on its medications for infantile spasms.

Upsher-Smith's parent company, Bora Pharmaceuticals Co., Ltd., recently acquired US-based Pyros Pharmaceuticals Inc., a leader in the development of enhanced specialty pharmaceuticals for rare diseases. The acquisition added VIGAFYDE™ (vigabatrin) Oral Solution to Upsher-Smith's portfolio of rare disease medications, making it the third vigabatrin formulation to be offered by Upsher-Smith, alongside VIGADRONE^® (vigabatrin) Powder for Oral Solution and Tablets. VIGAFYDE^™is the first and only ready-to-use vigabatrin oral solution and is indicated as monotherapy for the treatment of infantile spasms in pediatric patients 1 month to 2 years, where the potential benefits outweigh the potential risk of vision loss. VIGAFYDE™ is the first new drug application (NDA) approved for this condition in 15 years and represents a welcome expansion of vigabatrin treatment options, enabling customization of therapy to best meet the needs of individual patients and caregivers.

Innovation Pavilion Presentations
The Company also invites attendees to visit the Innovation Pavilion for informative presentations on vigabatrin between the hours of 12:30 pm – 1:30 pm on Saturday, December 7, 2024, Sunday, December 8, 2024, and Monday, December 9, 2024. The Innovation Pavilion is located in the exhibit hall (South Hall H, Level 1).

Scientific Posters for Presentation Include:

Dissolution and Stability of Vigabatrin Powder in Water, Fruit Juice, Milk, and Infant Formula
Poster 2.407; Sunday, December 8, 2024; 10 a.m. – 4 p.m. PST
Authors to present 12 p.m. to 2 p.m.
Los Angeles Convention Center, South Lobby, Street Level, South Hall H, Level 1

Comparison of Vigabatrin Oral Solution Versus Vigabatrin (SABRIL^®) Powder for Oral Solution in Infantile Spasms by Caregivers
Poster 2.398; Sunday, December 8, 2024; 10 a.m. – 4 p.m. PST
Authors to present 12 p.m. to 2 p.m.
Los Angeles Convention Center, South Lobby, Street Level, South Hall H, Level 1

Abstracts of the poster presentations can be found online at www.aesnet.org. To schedule an interview with a study author, please contact Elizabeth Likly at [email protected].

Upsher-Smith representatives will also be available at its commercial booths throughout the conference to engage with clinicians about its products. Products include the new ready-to-use vigabatrin solution, VIGAFYDE™ at Booth #1439, and VIGADRONE^® Powder for Oral Solution and Tablets and the Promise of Support™ Program, which has been providing comprehensive support to patients prescribed VIGADRONE^® since 2018, at Booth #1627.

About Upsher-Smith's Promise of Support™ Program
Central to Upsher-Smith's commitment to rare disease communities is its Promise of Support™ Program, ensuring comprehensive assistance for patients, caregivers, and healthcare providers throughout the treatment journey. For nearly a decade, the program has offered resources for uninterrupted medication supply, prior authorization support, patient education materials, collaboration with a leading specialty pharmacy partner, and streamlined prescribing and enrollment procedures. It also includes copay assistance for eligible patients to help lessen the financial burden on patients and their families.

To learn more about Upsher-Smith, its products, and the Promise of Support™ Program visit: www.upsher-smith.com.

Vigabatrin REMS
All vigabatrin products are governed by a Risk Evaluation and Mitigation Strategy (REMS) mandated by the FDA. The Vigabatrin REMS ensures that patients and healthcare providers make informed risk-benefit decisions about its use.

Healthcare providers must be enrolled in the Vigabatrin REMS to prescribe these products, and patients must be enrolled to receive them.

IMPORTANT SAFETY INFORMATION FOR VIGAFYDE™ (vigabatrin)

WARNING: PERMANENT VISION LOSS

See full prescribing information for complete boxed warning.

VIGAFYDE can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGAFYDE may also decrease visual acuity.
Risk increases with increasing dose and cumulative exposure, but there is no dose or exposure to VIGAFYDE known to be free of risk of vision loss.
Risk of new and worsening vision loss continues as long as VIGAFYDE is used, and possibly after discontinuing VIGAFYDE.
Baseline and periodic vision assessment is recommended for patients on VIGAFYDE. However, this assessment cannot always prevent vision damage.
VIGAFYDE is available only through a restricted program called the Vigabatrin REMS.

What is the most important information I should know about VIGAFYDE?

VIGAFYDE can cause serious side effects, including:

Permanent vision loss: VIGAFYDE can damage the vision of anyone who takes it. Some babies can have severe loss, particularly to their ability to see to the side when they look straight ahead (peripheral vision). With severe vision loss, your baby may only be able to see things straight in front of them (sometimes called "tunnel vision"). Your baby also may have blurry vision. If this happens, it will not get better.

Tell your healthcare provider right away if your baby might not be seeing as well as before starting VIGAFYDE or is acting differently than normal.

Vision loss in babies: Because of the risk of vision loss, VIGAFYDE is used in babies 1 month to 2 years of age with infantile spasms only when you and your healthcare provider decide that the possible benefits of VIGAFYDE are more important than the risks.

Parents or caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe. Healthcare providers may not find vision loss in babies until it is severe.

It is difficult to test vision in babies, but, to the extent possible, all babies should have their vision tested before starting VIGAFYDE or within 4 weeks after starting VIGAFYDE, and every 3 months after that until VIGAFYDE is stopped. Your baby also should have a vision test about 3 to 6 months after VIGAFYDE is stopped.

Your healthcare provider will determine if your baby can be tested. If your baby cannot be tested, your healthcare provider may continue prescribing VIGAFYDE, but they will not be able to watch for any vision loss.

Even if your baby's vision seems fine, it is important to get regular vision tests because damage can happen before your baby acts differently. Even these regular vision exams may not show the damage to your baby's vision before it is severe and permanent.

All babies who take VIGAFYDE:

Are at risk for permanent vision loss with any amount of VIGAFYDE.

The risk of vision loss may increase with higher doses of VIGAFYDE, and the longer it is taken.

It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting VIGAFYDE or any time during treatment. It may even happen after treatment has stopped.

Because VIGAFYDE might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called Vigabatrin Risk Evaluation and Mitigation Strategy (REMS). Your healthcare provider will explain the details of the Vigabatrin REMS to you. For more information, go to or call 1-866-244-8175.

Magnetic resonance imaging (MRI) changes in babies with infantile spasms (IS): brain pictures taken by MRI show changes in some babies after they are given VIGAFYDE. It is not known if these changes are harmful.

What are the possible side effects of VIGAFYDE?

VIGAFYDE can cause serious side effects, including sleepiness (sleepy babies may have a harder time suckling and feeding or may be irritable) and weight gain without swelling. Serious side effects that happen in adults who take vigabatrin and are not known if they will happen in babies are low red blood cell counts, nerve problems, and swelling.

Tell your baby's healthcare provider right away if your baby's seizures get worse.

The most common side effects of VIGAFYDE in babies include sleepiness, ear infection, swelling of the bronchial tubes, and irritability.

Tell your healthcare provider if your baby has any side effect that bothers them or that does not go away. These are not all the possible side effects of VIGAFYDE.

Do not stop taking VIGAFYDE suddenly. This can cause serious problems. Talk to your healthcare provider for directions on how to stop treatment.

What should I tell my healthcare provider before starting VIGAFYDE?

Before giving VIGAFYDE to your baby for IS, inform your healthcare provider about all your baby's medical conditions. This includes whether your baby has ever had an allergic reaction to vigabatrin, such as hives, itching, or trouble breathing, as well as any history of vision problems, or kidney issues. Tell your healthcare provider about all the medicines your baby takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Interactions between VIGAFYDE and other medicines could lead to side effects.

You may report side effects to the FDA at http://www.fda.gov/medwatch or call 1-800-FDA-1088 or Pyros at 1-855-406-1010.

Please see full Prescribing Information, including BOXED WARNING, Medication Guide, and Instructions for Use for additional Important Safety Information.

WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW ABOUT VIGADRONE^® (vigabatrin)?

WARNING: PERMANENT VISION LOSS

See Medication Guide and full Prescribing Information for complete information.

All people who take VIGADRONE:

You are at risk for permanent vision loss with any amount of VIGADRONE.
Your risk of vision loss may be higher the more VIGADRONE you take daily and the longer you take it.
It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting VIGADRONE or any time during treatment. It may even happen after treatment has stopped.

Because VIGADRONE might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain the details of this Program to you.
VIGADRONE can damage the vision of anyone who takes it. Some people can have severe loss, particularly to their ability to see to the side when looking straight ahead (peripheral vision). With severe vision loss, you may only be able to see things straight in front of you (sometimes called "tunnel vision"). You may also have blurry vision. If this happens, it will not get better.
Tell your healthcare provider right away if you (or your child): might not be seeing as well as before starting VIGADRONE; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of you that seem to come out of nowhere; or if your baby is acting differently than normal. These changes can mean that vision damage has occurred.
Regular vision testing is recommended. It is recommended that your healthcare provider test your (or your child's) vision before or within 4 weeks after starting VIGADRONE, and at least every 3 months during treatment until VIGADRONE is stopped. It is also recommended that vision be tested about 3 to 6 months after VIGADRONE is stopped. It is difficult to test vision in babies, but to the extent possible, all patients should have their vision tested. Your healthcare provider will determine if testing can be done. Regular vision testing is important because damage can happen before any changes are noticed.
Vision tests cannot prevent the vision damage that can happen with VIGADRONE, but they do allow VIGADRONE to be stopped if vision has gotten worse, which usually will lessen further damage. Even these regular vision tests may not show vision damage before it is serious and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in patients, until it is severe.
If you do not have these vision tests regularly, your healthcare provider may stop prescribing VIGADRONE for you (or your child). Some people are not able to complete vision testing. If vision testing cannot be done, your healthcare provider may continue prescribing VIGADRONE, but will not be able to watch for any vision loss.
Magnetic resonance imaging (MRI) changes in patients with infantile spasms (IS). Brain pictures taken by MRI show changes in some patients after they are given VIGADRONE. It is not known if these changes are harmful.
A type of swelling in the brain called intramyelinic edema (IME) has been seen in autopsy examination of patients treated with vigabatrin.
Risk of suicidal thoughts or actions. Like other antiepileptic drugs, VIGADRONE may cause suicidal thoughts and actions in some people (about 1 in 500 people). Call a healthcare provider right away if you (or your child) have any symptoms, especially sudden changes in mood, behaviors, thoughts or feelings, and especially if they are new, worse, or worry you.
Do not stop VIGADRONE without first talking to a healthcare provider. Stopping VIGADRONE suddenly can cause seizures that will not stop.

VIGADRONE can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, nerve problems, weight gain, and swelling. Because VIGADRONE causes sleepiness and tiredness, do not drive, operate machinery, or perform any hazardous task, unless it is decided that these things can be done safely. VIGADRONE may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.

Before starting VIGADRONE, tell your doctor about all of your (or your child's) medical conditions including depression, mood problems, suicidal thoughts or behavior, any allergic reaction to VIGADRONE, vision problems, kidney problems, low red blood cell counts (anemia), and any nervous or mental illnesses. Tell your doctor about all the medicines you (or your child) take.

If you are breastfeeding or plan to breastfeed, VIGADRONE can pass into breast milk and may harm your baby. Breastfeeding is not recommended.

If you are pregnant or plan to become pregnant, VIGADRONE can cause harm to your unborn baby. You and your healthcare provider will have to decide if you should take VIGADRONE while you are pregnant.

The most common side effects of VIGADRONE in adults include: blurred vision, sleepiness, dizziness, problems walking or feeling uncoordinated, shaking (tremor) and tiredness.

The most common side effect of VIGADRONE in children 3 to 16 years of age is weight gain. Also expect side effects like those seen in adults.

The most common side effects of VIGADRONE in babies include: sleepiness (sleepy babies may have a harder time suckling and feeding or may be irritable), swelling in the bronchial tubes (bronchitis), ear infection and irritability.

Tell your healthcare provider if you or your child have any side effect that bothers you or that does not go away.

This is the most important information to know about VIGADRONE, but it is not all the safety information. For more information, ask your healthcare provider or pharmacist, or please see the VIGADRONE Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use. You can also visit VIGADRONE.com, 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 1-800-332-1088.

WHAT IS VIGADRONE?
VIGADRONE^® (vigabatrin) is a prescription medicine used to treat:

Infantile Spasms (IS) in patients 1 month to 2 years of age, if you and your healthcare provider decide the possible benefits of taking VIGADRONE are more important than the possible risk of vision loss.
Refractory Complex Partial Seizures (CPS) in adults and children 2 years and older with refractory complex partial seizures (CPS) along with other treatments if:
- The CPS do not respond well enough to several other treatments, and
- You and your healthcare provider decide the possible benefit of taking VIGADRONE is more important than the risk of vision loss.

VIGADRONE should not be the first medicine used to treat CPS.

About Upsher-Smith
Upsher-Smith Laboratories, LLC, now a member of Bora Group, is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. We bring generics and brands to a wide array of customers, always backed by our attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com.

About Bora
Founded in 2007, Bora Pharmaceutical Co., Ltd. ("Bora" or "the Company", 6472.TW) now is the largest pharmaceutical manufacturer in Taiwan with well-connected global distribution to supply more than 100 countries around the world. Bora is dedicated to becoming a global leader in pharmaceutical manufacturing by offering its clients the best quality, efficiency and reliability. For more information, visit www.bora-corp.com.

VIGADRONE and Promise of Support are trademarks of Upsher-Smith Laboratories, LLC.
VIGAFYDE is a trademark of Pyros Pharmaceuticals, Inc.

SOURCE Upsher-Smith Laboratories, LLC