FromEpilepsy AwarenessDayatDisneylandtotheAmerican EpilepsySocietyAnnual Meeting, the company continues its mission to improve understanding and care for people living with epilepsy and infantile spasms.
Upsher-Smith Laboratories, LLC(Upsher-Smith) today reaffirmed its ongoing commitment to the epilepsy community by recognizing National Epilepsy Awareness Month and participating in key events throughout November and December. Through these efforts, the company continues to connect with patients, caregivers, and healthcare professionals while advancing understanding for those living with epilepsy and infantile spasms.
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“At Upsher-Smith, we take time during National Epilepsy Awareness Month to recognize the strength of those living with epilepsy and the families who support them,” said Rich Dudek, Vice President of Commercial Operations, Upsher-Smith. “As we participate in important awareness and education events in November, we also look ahead to December-supporting Infantile Spasms Awareness Week and engaging with clinicians at the American Epilepsy Society Annual Meeting.”
ChampioningtheEpilepsyCommunityThroughOngoingAdvocacy andAwareness Activities
Earlier this month, Upsher-Smith joined patients, families, and caregivers at the 13th Annual Epilepsy Awareness Day at Disneyland (EADDL) in Anaheim, California. Hosted bySofie's Journey, a nonprofit created by parents seeking better education and support for families affected by epilepsy, EADDL has grown into one of the largest gatherings of patients, caregivers and healthcare professionals. The event offered educational sessions, expert panels, interactive activities for children, and opportunities for families to connect and share their experiences.
While there, Upsher-Smith participated in the Epilepsy Awareness & Education Expo to connect with attendees and share information aboutVIGAFYDE® (vigabatrin)Oral Solution, thefirst and only ready-to-use vigabatrin oral solution for patients 1 month to 2 years of age with infantile spasms and the company's comprehensive Promise of Support® Program, which provides resources and assistance for healthcare providers, patients, and caregivers.
From December 1-7, 2025, Upsher-Smith will serve as a presenting sponsor of the Eleventh Annual Infantile Spasms Awareness Week (ISAW), a global initiative organized by the Infantile Spasms Awareness Network (ISAN). The campaign unites 39 international organizations to raise awareness about infantile spasms, a rare but serious form of epilepsy that requires urgent recognition and treatment. ISAW focuses on educating healthcare professionals and families about the signs of infantile spasms, new research, and the support available to affected families.
AdvancingClinicalKnowledgeofInfantileSpasms attheAESAnnualMeeting
Upsher-SmithwillalsoparticipateintheAmerican EpilepsySociety(AES)AnnualMeeting, held December 5-9, 2025, in Atlanta, GA. Company representatives will be available at booth #113 to share information with clinicians about its expanding portfolio of products for rare diseases.
Aspartofthemeeting,Upsher-Smithwillsponsorasatellitesymposium,titled”FromCrisis to Care – Striving to Optimize Outcomes in Infantile Spasms.” This educational program is scheduledforSaturday,December6,at6:00p.m. ET attheGeorgiaWorldCongress Center, Building B, Level 2, Room 216. It will feature leading experts in the field, including:
— SarahWeatherspoon,MD;LeBonheur Children'sHospital
— Michael Chez,MD,FAAN,FAES; SutterNeuroscienceInstitute
— SonamBhalla,MD;Children'sHealthcareofAtlanta
— MuhammadZafar,MD;DukeUniversityHospital
The symposium will follow a patient's journey with infantile spasms-from diagnosis to initial treatment and coordinated care plans-with discussions focusing on early recognition, treatmentoptions,individualizedmanagement,andcaregiver support.Ifyou're attendingAES, you can pre-register for the symposium at: https://scnv.io/Imk2.
Tolearn moreaboutUpsher-Smith'scommitmenttorarepediatricdiseases,visitwww.upsher-smith.com.
VigabatrinREMS Allvigabatrin products are governed by a Risk Evaluation and Mitigation Strategy (REMS) mandated by the Food and Drug Administration (FDA). The Vigabatrin REMS ensures that patientsandhealthcareprovidersmakeinformed risk-benefitdecisionsabout itsusetomitigate vision loss associated with vigabatrin.
Healthcareprovidersmustbeenrolled intheVigabatrinREMStoprescribethese products,and patients must be enrolled to receive them.
WHATISVIGAFYDE? VIGAFYDE®(vigabatrin)OralSolutionisaprescriptionmedicineusedtotreat:
— Infantile Spasms (IS)inbabies 1monthto2yearsofage,ifyouandyourbaby's healthcare provider decide the possible benefits of taking VIGAFYDE are more important than the possible risk of vision loss.
WHATIMPORTANTSAFETYINFORMATIONSHOULDIKNOWABOUTVIGAFYDE (vigabatrin)?
— BecauseVIGAFYDE might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk EvaluationandMitigationStrategy(REMS)Program. Yourbaby'shealthcareprovider will explain the details of this Program to you.
— VIGAFYDEcandamage thevisionof anyone whotakesit. Somepeoplecanhavesevere loss, particularly to their ability to see to the side when looking straight ahead (peripheral vision).With severe vision loss, your babymayonly be abletoseethings straightinfrontof them (sometimes called “tunnel vision”). Your baby may also have blurry vision. If this happens, it will not get better.
— Tell your healthcare provider right away if your babymightnotbeseeing aswellasbefore starting VIGAFYDE or is acting differently than normal. These changes can mean thatvision damage has occurred.
— Regular vision testing is recommended.It is recommended that your healthcare provider testyourbaby's visionbeforeorwithin4weeksafter startingVIGAFYDE,andatleastevery 3 months during treatment until VIGAFYDE is stopped. It is also recommended that vision be tested about 3 to 6 months after VIGAFYDE is stopped. It is difficult to test vision in babies, but to the extent possible, all patients should have their vision tested. Your baby's healthcare provider will determine if testing can be done. Regular visiontesting is important because damage can happen before any changes are noticed.
— Vision tests cannot prevent the vision damagethat can happen with VIGAFYDE, but they doallowVIGAFYDE tobestoppedifvision hasgottenworse, whichusuallywilllessenfurther damage.Eventheseregular visiontestsmaynotshowvisiondamagebefore itisseriousand permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in babies, until it is severe.
— If you do not have these vision tests regularly, your baby's healthcare provider may stop prescribing VIGAFYDE. Yourbabymaynot beabletocompletevisiontesting.If vision testing cannot be done, the healthcare provider may continue prescribing VIGAFYDE but will not be able to watch for any vision loss.
— Magnetic resonance imaging (MRI)changesinpatientswithinfantilespasms(IS). Brain pictures taken by MRI show changes in some patients after they are given VIGAFYDE. It is not known if these changes are harmful.
— A type of swelling in the brain called intramyelinicedema(IME)hasbeenseen in postmortem examination of infants treated with vigabatrin.
— Risk of suicidal thoughts or actions. VIGAFYDEisapproved foruseinpatients1monthto 2 years of age [see WHAT IS VIGAFYDE?]. VIGAFYDE is not approved for use in adolescents or adults.Like other antiepileptic drugs, vigabatrin may cause suicidal thoughts and actions in some adolescents and adults (about 1 in 500 people).A healthcare provider should be called right away if a patient taking vigabatrin experiences any symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings, and especially if they are new, worse, or worrying.
— Do not stopVIGAFYDEwithout firsttalkingtoahealthcareprovider.Stopping VIGAFYDE suddenly can cause seizures that will not stop.
VIGAFYDE is more concentrated than vigabatrin solutions prepared from powder. The volumeofVIGAFYDEsolution prescribedbyyourbaby'shealthcareprovidermaybelessthan the volume prescribed for other vigabatrin solutions prepared from powder. Always double check the volume (mL) that you are to give your baby when you get a new prescription filled.
VIGAFYDEcancauseserious sideeffectssuch aslowredbloodcellcounts(anemia), sleepiness and tiredness, and weight gain.
VIGAFYDEmaymakecertain typesofseizures worse.Tellyourhealthcareprovider right away if seizures get worse.
Before starting VIGAFYDE, tell your baby's doctor about all of their medical conditions includinganyallergicreaction tovigabatrin,vision problems,kidneyproblems,orlowredblood cell counts (anemia). Tell your doctor about all the medicines your baby is receiving.
The most common side effects of VIGAFYDE in babies include: sleepiness (sleepy babies mayhaveaharder timesucklingandfeedingormaybeirritable),swelling inthebronchialtubes (bronchitis), ear infection and irritability.
Tellyourhealthcareproviderifyourbabyhasanysideeffectthatbothersthemorthat does not go away.
Thisisthemostimportantinformationtoknow about VIGAFYDE,butnotallofthesafety information. For more information, ask your healthcare provider or pharmacist, or please see the VIGAFYDE Medication Guide, full Prescribing Informationincluding Boxed Warning for risk of permanent vision loss, and Instructions for Use. You can also visit VIGAFYDE.com, upsher-smith.comor call 1-888-650-3789.
Youareencouragedtoreportnegative sideeffectsofprescriptiondrugs totheFDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088.
AboutUpsher-Smith Laboratories,LLCUpsher-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 andbrandstoawidearrayofcustomers,always backedbyourattentivelevelofservice, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com.
AboutBora GroupFounded in 2007, Bora Pharmaceuticals (“Bora” or “the Company”, 6472.TW) is a leading pharmaceutical services company with a vision and goal of “Contributing to Better Health All OvertheWorld”. Operatingundera”DualEngine” modelthatintegratesCDMOandcommercial expertise, we empower pharmaceutical and biotech partners to optimize product development, accelerate launches, and scale supply to meet global patient needs. At the same time, we actively broaden R&D and sales infrastructure, focusing on niche and rare disease markets to improve patients' quality of life. By investing in talent, infrastructure, and biologics expansion, Bora continues to transform operations and achieve sustainable growth. For more information, visit www.bora-corp.com.
VIGAFYDEisaregisteredtrademarkofPyros Pharmaceuticals,Inc.PromiseofSupportisaregisteredtrademarkofUpsher-SmithLaboratories,LLC.
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