Vigabatrin

Pyros Pharmaceuticals Announces VIGPODER™ (vigabatrin) is Now Available

Retrieved on: 
Monday, April 1, 2024
Parenting, FDA, Neurology, Children, Biotechnology, Family, Health, Consumer, Pharmaceutical, Diagnosis, Epilepsy, Medication, USP, Pyros, Caregiver, Patient, Epileptic spasms, Child, Vigabatrin, Spasm, Safety, Multimedia, Central Time, Pharmaceutical industry

Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced today that VIGPODER™ (vigabatrin) for oral solution, USP, a treatment for appropriate patients with infantile spasms (IS), is now available.

Key Points: 
  • Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced today that VIGPODER™ (vigabatrin) for oral solution, USP, a treatment for appropriate patients with infantile spasms (IS), is now available.
  • As a therapeutically equivalent product, VIGPODER™ is anticipated to offer the same safety and efficacy profile as SABRIL® (vigabatrin) for oral solution.
  • Additionally, Pyros Total Care™, the Company’s personalized comprehensive support program, is available to assist families throughout the treatment journey.
  • "The launch of VIGPODER™ and the Pyros Total Care™ program underscores our dedication to supporting families facing the challenges of infantile spasms," stated Michael Smith, Chief Executive Officer at Pyros.

Ovid Therapeutics Reports Business Updates, Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Friday, March 8, 2024
Graviton, Epilepsy, Pharmacy technician, CCM, Research, Transcranial magnetic stimulation, DS, Neuron, Vigabatrin, LGS, Psychosis, Biomarker, Element, Ligand Pharmaceuticals, Lennox–Gastaut syndrome, Patient, Acceleration, Medicine, Status epilepticus, Dravet syndrome, ROCK2, KCC2, Hemangioma, IND, Seizure, Pharmaceutical industry

In addition, Takeda is expected to read out results from two pivotal Phase 3 studies evaluating soticlestat.

Key Points: 
  • In addition, Takeda is expected to read out results from two pivotal Phase 3 studies evaluating soticlestat.
  • Of these potential future payments, Ovid sold a 13% interest to Ligand Pharmaceuticals for $30 million in October 2023.
  • Financial runway: Ovid anticipates its cash runway will support operations and clinical development programs into the first half of 2026.
  • Ovid also anticipates several events for its current pipeline programs and clinical results for soticlestat from Takeda in 2024.

InvaGen Pharmaceuticals Issues Voluntary Nationwide Recall of Vigabatrin for Oral Solution, USP 500mg due to Leaking Sachets

Retrieved on: 
Friday, December 15, 2023
Online, Medicine, NDC, Cipla, Telephone, Food, USP, Completeness, Risk, Patient, Phenytoin, Probability, FDA, Seizure, Consumer, Knowledge, Vaccine, Dietary supplement, Vigabatrin

Cipla has not received any reports of adverse events related to this recall.

Key Points: 
  • Cipla has not received any reports of adverse events related to this recall.
  • The medication is packaged in foil pouches, each containing 500mg of Vigabatrin, and there are 50 foil sealed pouches in a shelf pack.
  • The Vigabatrin for Oral Solution, USP 500mg product was distributed nationwide to partnered distributors and consignees.
  • Distributors, retailers and consumers in possession of Vigabatrin for Oral Solution, USP 500mg Batch No.

Public advisory - Sabril (vigabatrin) 500 mg sachets and tablets found to contain trace amounts of another drug

Retrieved on: 
Thursday, November 9, 2023
Health Canada, Seizure, Risk, Tablet, Tic, Allergy, Patient, Agitation, Child, Spasm, Throat, Mouth, Aggression, Dyskinesia, Psychosis, Pharmacy, Pharmaceutical industry, Nursing, Dietary supplement, Medical device, Vigabatrin

Further to the advisory below, in discussion with Health Canada, Lundbeck Canada Inc. is releasing one lot of Sabril (vigabatrin) 500 mg tablets on the Canadian market found to contain trace amounts of another prescription drug, tiapride.

Key Points: 
  • Further to the advisory below, in discussion with Health Canada, Lundbeck Canada Inc. is releasing one lot of Sabril (vigabatrin) 500 mg tablets on the Canadian market found to contain trace amounts of another prescription drug, tiapride.
  • To help mitigate the ongoing shortage, Health Canada is working with stakeholders to monitor the supply of sachets and tablets.
  • Further to the advisory below, in discussion with Health Canada, Lundbeck Canada Inc. is releasing an additional lot Sabril (vigabatrin) 500 mg in sachet format on the Canadian market found to contain trace amounts of another prescription drug, tiapride.
  • Original Advisory – August 18, 2023:
    Lundbeck Canada Inc. has informed Health Canada that two lots of Sabril (vigabatrin) 500 mg powder for oral solution, in sachet format, were found to contain trace amounts of another prescription drug, tiapride.

Cerecin to Present New Infantile Spasms Data at the 35th International Epilepsy Congress, Dublin 2023

Retrieved on: 
Tuesday, August 29, 2023
Epilepsy, Incidence, Seizure, Maintenance, Prednisolone, Hypsarrhythmia, Drug discovery, Spasm, Ketone bodies, Adrenocorticotropic hormone, EMA, Plasma, US, Disorder, Patient, Nature, Risk, Vigabatrin, Epileptic spasms, IND, Caregiver, Safety, SLC6A1 epileptic encephalopathy, Pharmaceutical industry, Dietary supplement

DENVER, Aug. 29, 2023 /PRNewswire/ -- Cerecin Inc., a clinical-stage biotechnology company at the forefront of developing innovative neurotherapeutics, today announced that new data on investigational CER-0001 (tricaprilin) in infantile spasms (also known as West syndrome) has been accepted for presentation at the 35th International Epilepsy Congress, held in Dublin, Ireland from September 2nd-6th 2023.

Key Points: 
  • DENVER, Aug. 29, 2023 /PRNewswire/ -- Cerecin Inc., a clinical-stage biotechnology company at the forefront of developing innovative neurotherapeutics, today announced that new data on investigational CER-0001 (tricaprilin) in infantile spasms (also known as West syndrome) has been accepted for presentation at the 35th International Epilepsy Congress, held in Dublin, Ireland from September 2nd-6th 2023.
  • The presentation title is, "Treatment of Drug-Resistant Infantile Spasms with CER-0001, A Ketogenic Agent: Preliminary Results".
  • Infantile spasms usually affects children under the age of 36 months and can lead to permanent cognitive, neurologic and sensory problems.
  • Infantile spasms patients experience rapid, characteristic muscular contraction or extensions lasting one to two seconds and occurring in clusters ranging from a few spasms to more than 100 spasms per cluster.

Public advisory - Sabril (vigabatrin) 500 mg sachets found to contain trace amounts of another drug

Retrieved on: 
Friday, August 18, 2023
Seizure, Psychosis, Allergy, Tic, Spasm, Aggression, Teva Canada Ltd v Pfizer Canada Inc, Patient, Risk, Child, Dyskinesia, Throat, Health Canada, Agitation, Mouth, Dietary supplement, Pharmaceutical industry, Nursing, Medical device, Vigabatrin

Lundbeck Canada Inc. has informed Health Canada that two lots of Sabril (vigabatrin) 500 mg powder for oral solution, in sachet format, were found to contain trace amounts of another prescription drug, tiapride.

Key Points: 
  • Lundbeck Canada Inc. has informed Health Canada that two lots of Sabril (vigabatrin) 500 mg powder for oral solution, in sachet format, were found to contain trace amounts of another prescription drug, tiapride.
  • Sabril is a prescription drug used to manage epileptic seizures in adults and children, and for infantile spasms (West Syndrome).
  • Health Canada has determined that the health risk of the trace contamination to patients is low.
  • Sabril therapy should not be interrupted, as this may increase the risk of seizures, which could be life-threatening.

UPSHER-SMITH EXPANDS VIGADRONE® (VIGABATRIN) FRANCHISE TO INCLUDE TABLETS

Retrieved on: 
Tuesday, August 1, 2023
Seizure, REMS, Communication, Eye, Risk, Fatigue, Loss, Tremor, Depression, Bronchitis, Use, Medication, Mitigation, Otitis, Health care, Vision, Tablet, Spasm, Magnetic resonance imaging, Eye examination, Medicine, Brain, IME, Parent, Weight gain, Behavior, MRI, Suicidal ideation, Dizziness, Allergy, Patient, Peripheral vision, Swelling, Vigabatrin, CPS, Child, Anemia, Kidney, Somnolence, Irritation, Paratriathlon, FDA, Irritability, Autopsy, Caregiver, Safety, Breast milk, Health insurance, Hydraulic machinery, Retail, Medical device, Nursing, Residential care, Toy, Birth control, Medical imaging, Dietary supplement

MAPLE GROVE, Minn., July 31, 2023 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the recent launch of VIGADRONE® (vigabatrin) Tablets, USP 500 mg, a fully substitutable, AB-rated generic version of Sabril® (vigabatrin) Tablets, 500 mg.* The Company also offers VIGADRONE® (vigabatrin) for Oral Solution, USP 500 mg.

Key Points: 
  • Please see Important Safety Information, including Boxed Warning for Risk of Permanent Vision Loss at the end of this communication.
  • 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.
  • The most common side effects of VIGADRONE in adults include: blurred vision, sleepiness, dizziness, problems walking or feeling uncoordinated, shaking (tremor) and tiredness.

TSC Alliance Lauds Alabama State Legislature for Providing Funding to Support the University of Alabama at Birmingham TSC Center of Excellence

Retrieved on: 
Thursday, July 13, 2023
Epilepsy, Seizure, Heart, University, Alabama Legislature, Tuber, Spectrum, Neoplasm, Khan Bebin, Quality of life, Spasm, Research, Risk, Secretary of State of Alabama, Brain, Doctor of Philosophy, UAB, TSC, Patient, Intellectual, Diagnosis, MPA, Vigabatrin, Health, Skin, DSM-IV codes, Disease, Pharmaceutical industry, Vaccine, MD

SILVER SPRING, Md., July 13, 2023 /PRNewswire/ -- The TSC Alliance lauds the Alabama State Legislature, in particular Rep. Chris Pringle, for appropriating funding to support the University of Alabama at Birmingham (UAB) TSC Center of Excellence.

Key Points: 
  • SILVER SPRING, Md., July 13, 2023 /PRNewswire/ -- The TSC Alliance lauds the Alabama State Legislature, in particular Rep. Chris Pringle, for appropriating funding to support the University of Alabama at Birmingham (UAB) TSC Center of Excellence.
  • The additional funding will be targeted to support the TSC Clinic infrastructure and the UAB TSC research program.
  • The UAB TSC Clinic is a TSC Alliance Center of Excellence and is co-directed by Martina Bebin, MD, MPA, and Bruce Korf, MD, PhD.
  • "The TSC Alliance is incredibly grateful to Alabama State Legislature and Representative Chris Pringle, TSC Alliance Endowment Fund Chair Marion Adams and TSC Alliance of Greater Alabama Chair Margaret Cox for their leadership in securing this important funding," said Kari Luther Rosbeck, TSC Alliance President & CEO.

Cerecin received US FDA clearance to study CER-0001 under an Investigational New Drug (IND) application for Infantile Spasms

Retrieved on: 
Wednesday, December 7, 2022
Investigational New Drug, Adrenocorticotropic hormone, Neurology, Hypsarrhythmia, Patient, Epileptic spasms, Ketone bodies, Peripheral nervous system, Incidence, Smart contract, US Foods, Vigabatrin, Spasms, Safety, Migraine, IS, Spasm, Ketosis, Epilepsy, Prednisolone, Disorder, Research, Plasma, IND, Risk, Caregiver, Pharmaceutical industry

The open IND gives Cerecin clearance to proceed with the next phase of the planned development for CER-0001 in IS.

Key Points: 
  • The open IND gives Cerecin clearance to proceed with the next phase of the planned development for CER-0001 in IS.
  • IS usually affects children under the age of 36 months and can lead to cognitive, neurologic and sensory problems.
  • The disorder is commonly treated with hormonal medications (such as adrenocorticotropic hormone and prednisolone) and vigabatrin, an anticonvulsant.
  • Cerecin’s pilot study of CER-0001 is ongoing and will have recruited the 10th and final patient by 1H 2023.

Ovid Therapeutics to Present Data on Its Epilepsy Programs at American Epilepsy Society Annual Meeting (2022)

Retrieved on: 
Friday, December 2, 2022
Takeda Pharmaceutical Company, Lennox–Gastaut syndrome, Epilepsy, COVID-19, Safety, Vigabatrin, Seizure, Brain, Dravet syndrome, KCC2, Therapy, Benzodiazepine, CKM, MES, American Epilepsy Society, Security (finance), Annual general meeting, AES, Risk, Temporal lobe epilepsy, MB, Pharmaceutical industry, Takeda

If successful, these programs will provide hope for people with treatment-resistant epilepsies, said Jeremy Levin, D. Phil, MB BChir and Chairman and Chief Executive Officer of Ovid Therapeutics.

Key Points: 
  • If successful, these programs will provide hope for people with treatment-resistant epilepsies, said Jeremy Levin, D. Phil, MB BChir and Chairman and Chief Executive Officer of Ovid Therapeutics.
  • Our pipeline of potential medicines is designed with unique mechanisms of action to address the diverse, underlying pathophysiology of seizures.
  • Our data suggest OV329 to be a potent, next-generation GABA-AT inhibitor with the potential for seizure reduction with chronic, low dosing.
  • Data presented on OV350 support the therapeutic opportunity associated with activating KCC2, a novel target in epilepsy.