Epileptic spasms

Pyros Pharmaceuticals Announces VIGPODER™ (vigabatrin) is Now Available

Retrieved on: 
Montag, 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.

Pyros Pharmaceuticals Announces Positive Outcome of the European Decentralised Procedure for Approval of VIGZIP™ (vigabatrin oral solution)

Retrieved on: 
Donnerstag, Februar 15, 2024
Health, Consumer, Neurology, Children, Baby, Maternity, Pharmaceutical, Biotechnology, CMS, DCP, Spasm, Patient, Reference, Epilepsy, RMS, Medication, Epileptic spasms, Medical device, Pharmaceutical industry

Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced today the positive outcome of the Decentralised Procedure (DCP) for VIGZIP™ (vigabatrin oral solution) in Europe.

Key Points: 
  • Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced today the positive outcome of the Decentralised Procedure (DCP) for VIGZIP™ (vigabatrin oral solution) in Europe.
  • "We are incredibly pleased with the positive outcome supporting the approval of VIGZIP™ in several key European markets.
  • This achievement serves as a testament to our dedication to developing innovative solutions for unmet medical needs in rare pediatric diseases.
  • Pyros remains committed to expanding access to VIGZIP™ in other additional territories around the world,” stated Michael Smith, Chief Executive Officer of Pyros.

Ninth Annual Infantile Spasms Awareness Week Scheduled for December 1-7

Retrieved on: 
Montag, November 27, 2023
Brain, Research, Organization, Head, Movement, ISAN, Risk, Jerk, Patient, Colic, Epileptic spasms, Caregiver, Social media, Child, Mallinckrodt, Seizure, Spasm, Convulsion, Emergency, EEG, TSC, Front vowel, Upsher-Smith Laboratories, Brain damage, Pharmaceutical industry, ISAW

SILVER SPRING, Md., Nov. 27, 2023 /PRNewswire/ -- From December 1 to 7, 2023, a coalition of organizations will mark the Ninth Annual Infantile Spasms Awareness Week (ISAW).

Key Points: 
  • SILVER SPRING, Md., Nov. 27, 2023 /PRNewswire/ -- From December 1 to 7, 2023, a coalition of organizations will mark the Ninth Annual Infantile Spasms Awareness Week (ISAW).
  • The campaign is supported by the Infantile Spasms Awareness Network (ISAN), a coalition of 37 international organizations that have come together to inform families, healthcare providers and caregivers about the signs of infantile spasms.
  • "Because infantile spasms are a medical emergency, advocating for your baby is key and that's why Infantile Spasms Awareness Week is so important," said Kari Luther Rosbeck, President & CEO of the TSC Alliance®.
  • Infantile Spasms Awareness Week includes social media campaigns, national and local media interviews and physician awareness projects.

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

Retrieved on: 
Dienstag, 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.

ANAVEX Announces Issuance of New U.S. Intellectual Property Compositions Patent for ANAVEX®2-73 (blarcamesine)

Retrieved on: 
Donnerstag, Juni 1, 2023
Patent, Central nervous system, Therapy, United States Patent and Trademark Office, AND, Rett syndrome, Angelman syndrome, Doctor of Philosophy, CNS, DSM-IV codes, Fragile X syndrome, Central nervous system disease, Epileptic spasms, Pharmaceutical industry

11,661,405 entitled “CRYSTAL FORMS OF TETRAHYDRO-N,N-DIMETHYL-2,2-DIPHENYL-3-FURANMETHANAMINE HYDROCHLORIDE, PROCESSES OF MAKING SUCH FORMS, AND THEIR PHARMACEUTICAL COMPOSITIONS” from the United States Patent and Trademark Office (USPTO), expanding Anavex’s patent coverage of certain crystal forms of ANAVEX®2-73 (blarcamesine) compositions, processes of preparation, and uses thereof.

Key Points: 
  • 11,661,405 entitled “CRYSTAL FORMS OF TETRAHYDRO-N,N-DIMETHYL-2,2-DIPHENYL-3-FURANMETHANAMINE HYDROCHLORIDE, PROCESSES OF MAKING SUCH FORMS, AND THEIR PHARMACEUTICAL COMPOSITIONS” from the United States Patent and Trademark Office (USPTO), expanding Anavex’s patent coverage of certain crystal forms of ANAVEX®2-73 (blarcamesine) compositions, processes of preparation, and uses thereof.
  • Anavex’s newest patent will be expected to remain in force at least until October 2036, not including any patent term extensions.
  • The new patent will expand the coverage of certain ANAVEX®2-73 (blarcamesine) crystals covered by U.S. Patent No.
  • “We are extremely pleased with the continued development of the patent portfolio for ANAVEX®2-73 (blarcamesine) which demonstrates our continued commitment to protecting all aspects of the Anavex product portfolio.”

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

Retrieved on: 
Mittwoch, Dezember 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.

Longboard Pharmaceuticals to Participate in Five Upcoming Epilepsy-Focused Conferences this Summer

Retrieved on: 
Mittwoch, Juni 1, 2022
Life, International Family Planning and Development, Chemistry, Graduate School of Asia-Pacific Studies, Lennox–Gastaut syndrome, TSC, Seizure, Epilepsy, Research, Dravet Syndrome Foundation, Marketing, Epileptic Disorders, GABA, Conference, Safety, CDKL5, Central nervous system, Longboard, CDD, G protein-coupled receptor, Forward-looking statement, Syndrome, GPCR, Dravet syndrome, Government, Security (finance), U.S. Securities and Exchange Commission, LGS, GLOBE, Patient, Disagreement, DSF, Private Securities Litigation Reform Act, Coronavirus, Acquisition, COVID-19, Lists of diseases, Dees, Judgement, SEC, SAN, Myoclonus, CNS, Epileptic spasms, CB2, Pharmaceutical industry

"We are pleased to be included in these key epilepsy conferences this summer.

Key Points: 
  • "We are pleased to be included in these key epilepsy conferences this summer.
  • LP352 is designed to modulate GABA and, as a result, suppress the central hyperexcitability that is characteristic of seizures.
  • Longboard Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases.
  • Longboard disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Seventh Annual Infantile Spasms Awareness Week Scheduled for December 1-7

Retrieved on: 
Mittwoch, Dezember 1, 2021
Patient, Brain damage, Caregiver, Colic, CEO, Awareness, Brain, Head, Front vowel, Seizure, ISAN, Movement, Child, Convulsion, Epileptic spasms, Research, EEG, Risk, Jerking, Organization, Spasm, Emergency, Pharmaceutical industry

WASHINGTON, Dec. 1, 2021 /PRNewswire/ -- From December 1 to 7, 2021, a coalition of organizations will mark the seventh annual Infantile Spasms Awareness Week (ISAW).

Key Points: 
  • WASHINGTON, Dec. 1, 2021 /PRNewswire/ -- From December 1 to 7, 2021, a coalition of organizations will mark the seventh annual Infantile Spasms Awareness Week (ISAW).
  • The campaign is supported by the Infantile Spasms Awareness Network (ISAN), a coalition of 32 international organizations that have come together to inform families, healthcare providers and caregivers about the signs of infantile spasms.
  • "It's critical to remember infantile spasms are a medical emergency that should never be taken lightly, which is why Infantile Spasms Awareness Week is so important," said Kari Luther Rosbeck, President & CEO of the TSC Alliance.
  • "If you suspect your child may be showing symptoms of infantile spasms, informyour doctor immediately.

Cerecin Enrolls First Patient in a Pilot Clinical Trial of Tricaprilin in the Treatment of Infantile Spasms

Retrieved on: 
Dienstag, November 9, 2021
Safety, Vigabatrin, Ketosis, Migraine, Neurology, Organic acid, Epilepsy, Clinical trial, ACTH, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Hypsarrhythmia, GLOBE, Epileptic spasms, Therapy, Wilmar, Central nervous system, Spasm, Lipid, Drug development, Brain, Pharmaceutical industry

In October 2020, Cerecin received Rare Pediatric Disease Designation and Orphan Drug Designation for tricaprilin in Infantile Spasms from the U.S. Food and Drug Administration.

Key Points: 
  • In October 2020, Cerecin received Rare Pediatric Disease Designation and Orphan Drug Designation for tricaprilin in Infantile Spasms from the U.S. Food and Drug Administration.
  • The AC-21-024 clinical trial investigates the feasibility, safety, tolerability, and efficacy of daily administration of tricaprilin in participants with Infantile Spasms.
  • Infantile Spasms is seen in around 1 in every 3,000 infants globally and has unmet clinical needs.
  • In addition to the AC-21-024 study of tricaprilin in Infantile Spasms, Cerecin is currently conducting study AC-20-022 of tricaprilin in migraine prevention (NCT04437199 (The RELIEF trial)).

Longboard Pharmaceuticals Successfully Completes LP352 Multiple Ascending Dose Portion of Phase 1 Clinical Trial in Healthy Volunteers, Plans to Initiate Phase 1b/2a Clinical Trial

Retrieved on: 
Mittwoch, September 8, 2021

Longboard plans to advance LP352 into a Phase 1b/2a efficacy trial in adult participants with DEEs in the first quarter of 2022 in study sites across the United States.

Key Points: 
  • Longboard plans to advance LP352 into a Phase 1b/2a efficacy trial in adult participants with DEEs in the first quarter of 2022 in study sites across the United States.
  • The LP352 Phase 1 trial (N=83) was a first-in-human, randomized, placebo-controlled, double-blind, four-part trial including single ascending dose (SAD) and MAD assessments in healthy volunteers.
  • The primary objectives of the trial were to evaluate safety, tolerability, PK & PD of LP352.
  • In the MAD portion (N=43) of the trial, five doses including the maximum planned dose were evaluated.