Acetylcholine

U.S. FDA Approves First Therapeutic Indication for Revance’s DAXXIFY® (DaxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia

Retrieved on: 
Monday, August 14, 2023

Peter McAllister, M.D., ASPEN investigator and co-founder and medical director of the New England Institute for Neurology and Headache, commented: “As an ASPEN investigator, I am excited to see the approval of a new treatment option to address symptom reemergence prior to retreatment, a common issue for cervical dystonia patients. Currently, patients experience painful and life-limiting symptom recurrence as early as eight to 10 weeks in clinical practice but cannot be re-treated until 12 weeks. DAXXIFY® is the first long-acting neuromodulator that has the potential to address this significant unmet need -- demonstrating durable symptom relief between treatment cycles and providing the opportunity to extend treatment intervals.”

Key Points: 
  • In 2017, the U.S. FDA granted orphan drug designation to DAXXIFY® for the treatment of cervical dystonia in adults.
  • Further, we believe FDA approval represents a significant advancement in the treatment of cervical dystonia,” said Chief Executive Officer Mark J. Foley.
  • “DAXXIFY’s differentiated efficacy, duration and safety profile can help physicians deliver long-lasting symptom relief to patients suffering from cervical dystonia, while also helping payers address the total cost of care for this population.
  • DAXXIFY® is not approved for the treatment of spasticity or any conditions other than cervical dystonia and glabellar lines.

"Ebb and Flow" Brain Mechanism That Drives Learning Identified

Retrieved on: 
Wednesday, August 9, 2023

NEW YORK, Aug. 9, 2023 /PRNewswire/ -- Researchers have long thought that rewards like food or money encourage learning in the brain by causing the release of the "feel-good" hormone dopamine, known to reinforce storage of new information. Now, a new study in rodents describes how learning still occurs in the absence of an immediate incentive.

Key Points: 
  • Now, a new study in rodents describes how learning still occurs in the absence of an immediate incentive.
  • Rewards were thought to promote learning by simultaneously triggering an increase in dopamine and a decrease in acetylcholine.
  • This sudden hormone imbalance is believed to open a window of opportunity for brain cells to adjust to new circumstances and form memories for later use.
  • Known as neuroplasticity, this process is a major feature of learning as well as recovery after injury.

UCB announces U.S. FDA approval of RYSTIGGO® (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis

Retrieved on: 
Tuesday, June 27, 2023

"There is a significant need for new, innovative treatment options to reduce the day-to-day burden of gMG.

Key Points: 
  • "There is a significant need for new, innovative treatment options to reduce the day-to-day burden of gMG.
  • RYSTIGGO ® is a new treatment option, targeting one of the mechanisms of disease to provide symptom improvement in patient-and physician reported outcomes at day 43."
  • The approval of RYSTIGGO® means doctors have an additional approved treatment option for their gMG patients who have not yet found a treatment that meets their needs."
  • RYSTIGGO® is also currently under review by the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with gMG.

Catalyst Pharmaceuticals Advances sNDA Submission Plans To Increase Indicated Maximum Dose For FIRDAPSE® From 80 mg Per Day To 100 mg Per Day

Retrieved on: 
Tuesday, May 9, 2023

CORAL GABLES, Fla., May 09, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today reported that it recently concluded a Type C meeting with the U.S. Food and Drug Administration ("FDA" or "Agency") regarding its plans to file a supplemental New Drug Application ("sNDA") to increase the maximum daily dosage of FIRDAPSE® (amifampridine) from 80mg to 100mg for the treatment of Lambert Eaton myasthenic syndrome ("LEMS"). Based on the feedback received from the meeting, Catalyst believes it now has the information necessary to complete the submission of its sNDA for marketing approval in the U.S. early in the third quarter of 2023.

Key Points: 
  • "The meeting was held for alignment of our strategy to support a proposed maximum 100-milligram daily dose indication of FIRDAPSE," said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst.
  • "We thank the Agency for their collaboration in reviewing our submitted materials and providing their feedback.
  • Based on the positive outcome of the meeting, we remain on track to file an sNDA submission early in the third quarter of 2023.
  • These calcium channels are responsible for the transport of charged calcium atoms that activate the biochemical machinery responsible for releasing acetylcholine.

Black People Less Likely to Receive Dementia-Related Medications

Retrieved on: 
Monday, February 27, 2023

"However, there is limited data for the use of dementia medications that people take at home.

Key Points: 
  • "However, there is limited data for the use of dementia medications that people take at home.
  • Of this group, 3,655 were Black and 12,885 were white.
  • "Black people who saw a neurologist were receiving cholinesterase inhibitors and NMDA antagonists at rates more comparable to white people," said Hawkins.
  • Therefore, Hawkins said it remains unclear how much of the observed disparity is due to physicians prescribing fewer medications to Black people versus other patient-related factors, such as inability to afford medications.

Brain Health Supplements Global Market Report 2022: Need to Combat Neurological Disorders Boosts Demand - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 12, 2023

The brain health supplement market is predicted to surge with rise in aging population and to combat neurological disorders.

Key Points: 
  • The brain health supplement market is predicted to surge with rise in aging population and to combat neurological disorders.
  • The Brain Health Supplements Market is Expected to Grow at a CAGR of 10% from 2022 - 2030.
  • The online stores held the largest market in the global brain health supplements market due to availability of wide variety of products as compared to supermarkets/hypermarkets and drug stores.
  • North America is the largest regional market for brain health supplements accounting more than 54.8% of market share in 2021.

Flawless Faces Medspa Moves To 3165 S Alma School Road, Suite 29 In Chandler, Arizona

Retrieved on: 
Monday, November 21, 2022

They have now moved to 3165 S Alma School Rd, Suite 29 in Chandler, AZ, to offer clients in the Ocotillo community top-of-the-line products, the latest equipment, and industry-leading techniques to help you both look and feel your best.

Key Points: 
  • They have now moved to 3165 S Alma School Rd, Suite 29 in Chandler, AZ, to offer clients in the Ocotillo community top-of-the-line products, the latest equipment, and industry-leading techniques to help you both look and feel your best.
  • At Flawless Faces Med Spa in Chandler, AZ , the team aims for the highest standards in the beauty and cosmetic industry and always strives to exceed every one of their clients expectations.
  • It works by preventing the release of a neurotransmitter called acetylcholine, a chemical that tells your muscles to contract.
  • Flawless Faces Med Spa utilizes the highly regarded Restylane for their lip enhancement treatments.

CANbridge Pharmaceuticals Granted Orphan Drug Designation for CAN 106 for the Treatment of Myasthenia Gravis

Retrieved on: 
Wednesday, November 16, 2022

Orphan Drug Designation for CAN106 in MG is both a validation of CANbridge innovation and a major milestone as our first US FDA regulatory designation, said James Xue, Ph.D., CANbridge Founder, Chairman and CEO.

Key Points: 
  • Orphan Drug Designation for CAN106 in MG is both a validation of CANbridge innovation and a major milestone as our first US FDA regulatory designation, said James Xue, Ph.D., CANbridge Founder, Chairman and CEO.
  • We continue to advance our global development strategy for CAN106 and look forward to developing CAN106 for myasthenia gravis and other complement-mediated diseases.
  • CAN106 is a clinical-stage investigational novel, long-acting recombinant humanized monoclonal antibody that binds to and neutralizes C5, a key component of the complement system.
  • CAN106 acts downstream of C3 in the complement pathway, preserving the generation of C3a and C3b, which are important for innate immunity.

New Study Associates Behavior from Digital Cognitive Assessments with Key Biological Markers for Alzheimer’s Disease

Retrieved on: 
Wednesday, October 19, 2022

New research recently published in Frontiers in Aging Neuroscience provides further validation of the ability of digital clock drawing assessments to help uncover deficits in mental planning tied to certain biological markers.

Key Points: 
  • New research recently published in Frontiers in Aging Neuroscience provides further validation of the ability of digital clock drawing assessments to help uncover deficits in mental planning tied to certain biological markers.
  • Mental planning is a cognitive ability essential to the completion of complex tasks of daily living and frequently disrupted in individuals with mild cognitive impairment (MCI) and dementia, which often occur as a result of Alzheimer's disease.
  • The precision and automation of digital assessments reduces reliance on neuropsychology experts to analyze results, while objective scoring lessens subjectivity and inter-rater reliability issues.
  • The specific digital clock drawing test used in the study is proprietary Linus Health technology.

AEON Biopharma Reports Positive Topline Results from Phase 2 Clinical Trial of ABP-450 (prabotulinumtoxinA) in Cervical Dystonia

Retrieved on: 
Friday, September 23, 2022

IRVINE, Calif., Sept. 23, 2022 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”), a private clinical-stage biopharmaceutical company focused on the development of its proprietary botulinum toxin complex ABP-450 (prabotulinumtoxinA) injection for therapeutic indications, today announced positive topline results from its Phase 2 clinical study of ABP-450 for the treatment of cervical dystonia (CD), a chronic and debilitating neurologic condition affecting the muscles of the neck.

Key Points: 
  • ABP-450 contains a 900 kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.
  • AEON is a clinical stage biopharmaceutical company focused on developing ABP-450 (prabotulinumtoxinA) injection for the treatment of debilitating medical conditions with an initial focus on the neurology and gastroenterology markets.
  • This press release contains forward-looking statements that are based on managements belief and assumptions and on information currently available to management.
  • These and other important factors may cause actual results, performance, or achievements to differ materially from those expressed or implied by these forward-looking statements.