Orthostatic hypotension

Pharma Two B Announces Positive Topline Results from its Pivotal Phase III Study of P2B001 in Early Parkinson’s Disease

Retrieved on: 
Wednesday, December 15, 2021
Mount Sinai, Epworth Sleepiness Scale, FDA, Orthostatic hypotension, Neuroscience, Excessive daytime sleepiness, Calibration, UPDRS, M.B.A, III, Environment, Unified Parkinson's disease rating scale, Icahn School of Medicine at Mount Sinai, Pramipexole, Neurological disorder, Life expectancy, Capsule, Safety, University, Patient, Disease, ER, Neurology, PD, ESS, Hallucination, Part, Pharmaceutical industry

REHOVOT, Israel , Dec. 15, 2021 (GLOBE NEWSWIRE) -- Pharma Two B Ltd., a privately held company developing innovative therapeutics based on reformulation and combinations of previously approved drugs for neurological indications, today announced that its Phase III double-blind, active-controlled study of P2B001 in early Parkinson’s disease (PD) successfully met its primary and key secondary endpoints.

Key Points: 
  • The results demonstrated both superior efficacy to components and a more favorable safety profile than treatment with standard doses of pramipexole.
  • With increased life expectancy and longer disease duration, patients will often require dopaminergic replacement therapies for many years.
  • If approved, this product will be an important new option when considering a long-term care plan for people with early-stage Parkinsons disease.
  • The companys lead product P2B001 is being investigated as a treatment for early-stage Parkinsons disease.

Novel Blood Pressure Stabilization Therapy Presented at Neuroscience 2021

Retrieved on: 
Monday, November 15, 2021
Stem Cells, Biotechnology, Physical Therapy, Managed Care, Surgery, Health, Medical Devices, Other Health, Quality of life, Euronext, Swiss, Science, Spinal cord, Health, Blood pressure, Movement, Orthostatic hypotension, Technology, ARC, Lecture, EPFL, Innovation Park, Twitter, Company, LinkedIn, Swiss Federal Institute of Technology, High Tech Campus Eindhoven, Swiss Federal Institute of Aquatic Science and Technology, FDA, Pharmaceutical industry, Medical device

We were excited to demonstrate and discuss how this new approach may provide a viable and important therapy for people with spinal cord injury.

Key Points: 
  • We were excited to demonstrate and discuss how this new approach may provide a viable and important therapy for people with spinal cord injury.
  • This novel therapy is currently being investigated in the STIMO HEMO study, building on a discovery first published in Nature that identifies the low thoracic spinal cord as a hemodynamic hotspot, which when stimulated via a proprietary algorithm called ARC Therapy, has the potential to restore blood pressure stability after spinal cord injury.
  • ONWARD is developing and commercializing this therapy, leveraging its investigational ARCIM implantable device platform.
  • During his Presidential Special Lecture, Professor Courtine showed how stimulation of the hemodynamic hotspot elevated blood pressure in one of the STIMO HEMO participants.

Osmotica Pharmaceuticals plc Announces Debt Financing from Athyrium Capital Management of up to $100 Million

Retrieved on: 
Thursday, October 7, 2021
Company, Intellectual property, Patient, Headache, LP, Risk, Eye injury, Ptosis, Orbit, Aneurysm, Horner's syndrome, Duane syndrome, Metabolism, Myasthenia gravis, Orthostatic hypotension, Xanthine oxidase inhibitor, GLOBE, Terminology, Hypotension, U.S. Securities and Exchange Commission, Focal neurologic signs, Mark (given name), Nature, Blepharoplasty, Security (finance), Blood pressure, Stroke, Ophthalmoparesis, Glaucoma, Achievement, Hypertension, Face, Solution, Eye, Cardiovascular disease, Nasdaq, Glycosidic bond, Pharmaceutical industry, Financial services, Phosphorus

We are thrilled to partner with the Osmotica team and to provide capital to support the commercial efforts around Upneeq, said Mark Kavulich, Partner, Athyrium Capital Management.

Key Points: 
  • We are thrilled to partner with the Osmotica team and to provide capital to support the commercial efforts around Upneeq, said Mark Kavulich, Partner, Athyrium Capital Management.
  • Subject to the satisfaction of certain conditions, at closing of the agreement, Osmotica will issue $55 million of senior secured notes.
  • An additional $20 million of notes will be available to Osmotica at its option by October 2022 subject to the achievement of minimum Upneeq revenues.
  • Athyrium Capital Management, LP is a specialized asset management company formed in 2008 to focus on investment opportunities in the global healthcare sector.

PharmaTher Initiates Phase 2 Clinical Trial of Ketamine for the Treatment of Parkinson’s Disease

Retrieved on: 
Wednesday, October 6, 2021
Diamond, Dopamine, Clinical trial, Substance, Rigidity, OTCQB, Dyskinesia, Pharmacokinetics, Orthostatic hypotension, USD, L-DOPA, Dysautonomia, Clinical, III, Depression, Constipation, FDA, CSE, NMDA, Patient, Holding, Data management, Tremor, Central nervous system, Disease, CEO, Parkinson's disease, Substantia nigra, UPDRS, Company, OFF, Pain, Biostatistics, Trial of the century, Mental health, Drug combination, IND, Neurogenic bladder dysfunction, Psychiatry, Brain, Research, Lists of diseases, Randomness, Safety, LID, Movement, Levodopa-induced dyskinesia, Hypokinesia, Midazolam, GLOBE, Neuron, Pharmaceutical industry

The Phase 2 KET-LID clinical trial is a randomized, double-blind, active placebo-controlled study evaluating the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinsons disease.

Key Points: 
  • The Phase 2 KET-LID clinical trial is a randomized, double-blind, active placebo-controlled study evaluating the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinsons disease.
  • Clinical trial drug product (ketamine) and active placebo (midazolam) have also been obtained.
  • Initiation of the Phase 2 clinical trial of ketamine to treat Parkinsons disease, or the KET-LID trial, is a significant milestone for PharmaTher and we are excited about the opportunity to advance a potential new therapeutic solution for Parkinsons disease patients, said Fabio Chianelli, CEO of PharmaTher.
  • PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinsons disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.

Adamas Named 2021 Finalist in the New Therapeutics Category of the UCSF Health Awards

Retrieved on: 
Friday, October 1, 2021
Other Health, Research, General Health, Pharmaceutical, Medical Devices, Public Relations, Investor Relations, Science, Biotechnology, Communications, FDA, Other Science, Health, Dizziness, Delusion, Therapy, Psychosis, Rigidity, PWP Heavyweight Championship, Orthostatic hypotension, Depression, Somnolence, Walking, Patient, Dyskinesia, ADMS, Xerostomia, Behavior, Neurodegeneration, FDA, Constipation, Medication, Adamantas, Physician, Tremor, Caregiver, Standing, Confusion, Lists of diseases, Hallucination, Life, OFF, Eating, Delirium, Stupor, Falls, Dopamine, Risk, Paranoia, Gambling, PWP, PD, GOOD, Peripheral edema, Brain, Suicidal ideation, History, Amantadine, Anxiety, Hobby, Agitation, Suicide, Nasdaq, Time, L-DOPA, Pharmaceutical industry, Online shopping, Residential care, Liquor, Parkinson’s disease, dyskinesia and OFF, GOCOVRI, Adamas, PARKINSON’S DISEASE, DYSKINESIA AND OFF, GOCOVRI, ADAMAS

This years UCSF Health Awards program, which historically focused on the digital health tech industry, was expanded to include several life science categories.

Key Points: 
  • This years UCSF Health Awards program, which historically focused on the digital health tech industry, was expanded to include several life science categories.
  • Adamas developed GOCOVRI to make everyday life significantly better for people with Parkinsons disease, said Neil F. McFarlane, Chief Executive Officer.
  • It is, therefore, an honor to be selected as a finalist in a category recognizing the real impact innovative therapeutics can have on patients.
  • Id like to thank the Adamas team for their contributions which have enabled this recognition.

TYMLOS Label and Business Update

Retrieved on: 
Wednesday, September 22, 2021
Contraindication, RATS, Man, Bone, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Head, Paget, Vertigo, Female, Osteosarcoma, Kidney, Food, RAD1901, Alkaline phosphatase, Primary hyperparathyroidism, Hypercalciuria, Orthostatic hypotension, Tachycardia, American Society for Bone and Mineral Research, CEO, Kidney stone disease, Leadership, Journal, Male, Breathe Me, Prader–Willi syndrome, Bone fracture, History, Incidence, Headache, Pelvic fracture, Genzyme, Fatigue, NASDAQ, Parathyroid hormone, Boxed warning, Nausea, Company, Woman, Hives, Risk, Endocrinology, Human, Abaloparatide, PAG, GLOBE, Dizziness, PWS, Anaphylaxis, Palpitations, Fracture, Patient, Skeleton, Media relations, Osteoporosis, MOA, Access (group), Teriparatide, Dietary supplement, Pharmaceutical industry, Birth control, Medical imaging, Vaccine

Effective September 20, 2021, the following sentence was added to the MOA section of the TYMLOS (abaloparatide) label: Once-daily administration of abaloparatide stimulates new bone formation on trabecular and cortical bone surfaces by stimulation of osteoblastic activity.

Key Points: 
  • Effective September 20, 2021, the following sentence was added to the MOA section of the TYMLOS (abaloparatide) label: Once-daily administration of abaloparatide stimulates new bone formation on trabecular and cortical bone surfaces by stimulation of osteoblastic activity.
  • Dr. Bruce Mitlak, the Companys Chief Medical Officer, commented This is an important addition to the TYMLOS label as it highlights to our patients and prescribers the bone building MOA of the molecule.
  • Growing the abaloparatide franchises commercial business is a major focus of the Company.
  • In this role, Sal and his team will focus on the completeness of the TYMLOS patient journey including patient support and product access.

Adamas Announces GOCOVRI Presentations at the Upcoming International Parkinson and Movement Disorder Society’s (MDS) Congress

Retrieved on: 
Thursday, September 16, 2021
Nursing, Health, Managed Care, Clinical Trials, Pharmaceutical, Biotechnology, Tremor, Patient, Somnolence, Poster, PD, Adamantas, Depression, Delusion, Neurodegeneration, Stupor, Psychosis, Lists of diseases, Time, Constipation, Eating, Falls, MDS, Standing, Orthostatic hypotension, Dizziness, Delirium, Suicide, Hallucination, Caregiver, Gambling, Nasdaq, Dyskinesia, Agitation, Behavior, Peripheral edema, ITC, L-DOPA, FDA, Dopamine, Amantadine, Brain, Person, DBS, Paranoia, Medication, Suicidal ideation, Anxiety, OFF, Risk, Clinical trial, Xerostomia, Rigidity, ADMS, Confusion, GOOD, History, Deep brain stimulation, Pharmaceutical industry, Medical device, Residential care, Liquor, Parkinson’s Disease, dyskinesia and OFF, GOCOVRI, Adamas, PARKINSON’S DISEASE, DYSKINESIA AND OFF, GOCOVRI, ADAMAS

The results of this analysis support GOCOVRI as an early adjunctive treatment to levodopa for patients with early motor complications - OFF or dyskinesia.

Key Points: 
  • The results of this analysis support GOCOVRI as an early adjunctive treatment to levodopa for patients with early motor complications - OFF or dyskinesia.
  • Poster 520: The efficacy of GOCOVRI versus other formulations of amantadine were compared through a traditional Indirect Treatment Comparison (ITC) analysis.
  • Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with GOCOVRI because of the risk of exacerbating psychosis.
  • At Adamas our vision is clear to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society.

Adamas Announces Settlement of Patent Litigation with Zydus

Retrieved on: 
Monday, February 1, 2021
Biotechnology, Health, Professional services, Pharmaceutical, Legal, Vascular diseases, Hypotension, Generic drug, Orthostatic hypotension, Health, GOCOVRI®, Adamas Pharmaceuticals, Inc.

We are focused on building on the momentum from our strong 2020 performance and delivering growth for GOCOVRI in 2021.

Key Points: 
  • We are focused on building on the momentum from our strong 2020 performance and delivering growth for GOCOVRI in 2021.
  • Upon entry of the joint stipulation and order, this settlement agreement will conclude all patent litigation brought to date by Adamas against generic pharmaceutical companies that filed an ANDA seeking approval to market generic versions of GOCOVRI prior to the expiration of the patents listed in the Orange Book.
  • The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.
  • At Adamas, our purpose is clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society.

2020 Technologies For The Epidemic Of Falls

Retrieved on: 
Wednesday, December 18, 2019
Vascular diseases, Medical specialties, Organ systems, Medicine, Orthostatic hypotension, Hypotension, Falling, Standing, Lightheadedness, Sedation

Falls are not an inevitable part of aging and there are proven ways to reduce falls.

Key Points: 
  • Falls are not an inevitable part of aging and there are proven ways to reduce falls.
  • Ensure medications are not causing side effects such as lightheadedness, sedation, visual impairments, or orthostatic hypotension that increases one's risk for falls.
  • It is estimated the total medical costs for falls totaled more than $50 billion dollars last year (CDC, 2018).
  • New technologies are changing the way of healthcare delivery and management as it is becoming more complex and demanding.

The global orthostatic hypotension drugs market at a CAGR of almost 8% during the forecast period

Retrieved on: 
Monday, August 26, 2019
Vascular diseases, Hypotension, Organ systems, Drugs, Medicine, Orthostatic hypotension, Midodrine, Standing, Chronic condition, Orthostatic syncope, Orthostatic hypertension

This orthostatic hypotension drugs market analysis considers sale from midodrine, northera (droxidopa), fludrocortisone, and other drugs.

Key Points: 
  • This orthostatic hypotension drugs market analysis considers sale from midodrine, northera (droxidopa), fludrocortisone, and other drugs.
  • Our analysis also considers the orthostatic hypotension drugs market in Asia, Europe, North America, and ROW.
  • Global Orthostatic Hypotension Drugs Market: Overview
    The prevalence of the neurodegenerative diseases, cardiovascular diseases and diabetes is significantly increasing worldwide, raising the risk of OH.
  • This increase in prevalence of chronic diseases associated with high risk of OH will lead to the expansion of the global orthostatic hypotension drugs market at a CAGR of almost 8% during the forecast period.