Pain disorder

German Pain Association (DGS) and Pharmaceutical Company Avextra Join Forces to Launch Their New Study OCEAN

Retrieved on: 
Tuesday, January 23, 2024
OCEAN, Patient, Diabetic neuropathy, DGS, Pain disorder, Registered, CBM, Quality of life, Hypoesthesia, Safety, Observational study, Neuropathic pain, CINP, Pain, Chronic pain, THC, Possible (charity), Pharmaceutical industry

Avextra, the German pharmaceutical company focused on Cannabis-Based Medicines (CBM) and the German Pain Association (DGS), the leading physicians’ society dedicated to chronic pain therapy, jointly announces their collaboration to support patients suffering from Chemotherapy-induced neuropathic pain (CINP).

Key Points: 
  • Avextra, the German pharmaceutical company focused on Cannabis-Based Medicines (CBM) and the German Pain Association (DGS), the leading physicians’ society dedicated to chronic pain therapy, jointly announces their collaboration to support patients suffering from Chemotherapy-induced neuropathic pain (CINP).
  • BENSHEIM, Germany, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Avextra AG (“Avextra” or the “Company”), a leading European vertically-integrated manufacturer and developer of pharmaceutical cannabis-based medicines (CBMs) located in Germany, is proud to announce a joint study with the German Pain Association (DGS) focused on Chemotherapy-induced neuropathic pain (CINP).
  • Avextra is proud to collaborate with the German Pain Association (DGS) on their OCEAN study and address the research gap.
  • OCEAN will evaluate a number of factors including pain intensity, pain-related impairments, sleep quality and the phenotypes of neuropathic pain.

PharmaTher Announces FDA Acceptance, As a Priority Original Abbreviated New Drug Application, for KETARX™ (Ketamine)

Retrieved on: 
Wednesday, September 27, 2023
Pain disorder, Abbreviated New Drug Application, Partnership, CSE, Depression, Anxiety, Pain, Food and Drug Administration Safety and Innovation Act, Ketamine, Hospital, ANDA, Suicidal ideation, FDA, Health Canada, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mental health, Therapy, Food, Pharmaceutical industry

TORONTO, Sept. 27, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (“FDA”) has accepted the Abbreviated New Drug Application (“ANDA”) for KETARX™ (racemic ketamine) to the Food and Drug Administration (“FDA”). The FDA assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date for this priority original ANDA of April 29, 2024. The Company anticipates the commercial launch of KETARX™ in the U.S. after that, followed by the pursuit of international approvals to support the growing global demand for ketamine.

Key Points: 
  • The FDA assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date for this priority original ANDA of April 29, 2024.
  • The Company anticipates the commercial launch of KETARX™ in the U.S. after that, followed by the pursuit of international approvals to support the growing global demand for ketamine.
  • PharmaTher’s priority is to commercialize KETARX™ in the U.S. through its recently announced partnership with Vitruvias Therapeutics, Inc., a leading U.S. based specialty generic pharmaceutical company.
  • The Company expects to market various dosage forms of KETARX™, with the option to increase concentration and ready-to-administer applications for the U.S. and international markets.

PharmaTher Submits Priority Original Abbreviated New Drug Application for KETARX™ (Ketamine) to the FDA

Retrieved on: 
Wednesday, September 6, 2023
Pain disorder, Abbreviated New Drug Application, Partnership, CSE, Depression, Anxiety, Pain, Food and Drug Administration, Ketamine, Hospital, ANDA, Suicidal ideation, FDA, Health Canada, Mental health, Therapy, Food, Pharmaceutical industry

TORONTO, Sept. 06, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, is pleased to announce it has submitted a priority original Abbreviated New Drug Application (“ANDA”) for KETARX™ (racemic ketamine) to the Food and Drug Administration (“FDA”) for expedited review of its ANDA.

Key Points: 
  • TORONTO, Sept. 06, 2023 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a commercial-focused specialty pharmaceutical company, is pleased to announce it has submitted a priority original Abbreviated New Drug Application (“ANDA”) for KETARX™ (racemic ketamine) to the Food and Drug Administration (“FDA”) for expedited review of its ANDA.
  • The Company anticipates KETARX™ approval and commercial launch in the U.S. in Q2-2024, followed by the pursuit of international approvals to support the growing global demand for ketamine.
  • Ketamine has been on the FDA’s drug shortage list since February 2018.
  • A recently published new peer-reviewed study on the real-world effectiveness of ketamine intravenous therapy demonstrated significant patient improvement for depression, anxiety and suicidal ideation.

Dr. Andres Betts Joins Pain Medicine Associates - Mission Viejo, California

Retrieved on: 
Tuesday, July 18, 2023
Pain disorder, University, Long Beach, California, Cranial nerves, Critical Care Medicine (journal), Skiing, Sciatica, Alfred Noble Prize, Spine, Radiofrequency ablation, Suite, Piriformis syndrome, PMA, University of California, Irvine Medical Center, Patient, Physician, Pain Clinic, Associate, Mountaineering, Pain, Diagnosis, Sacral fracture, Bone fracture, General surgery, Nursing, Dentistry, Anesthesiology, Medicine

MISSION VIEJO, Calif., July 18, 2023 /PRNewswire-PRWeb/ -- Pain Medicine Associates (PMA) is pleased to announce that interventional pain management specialist Andres Betts, M.D., has joined the company's Mission Viejo, California pain management practice. He began seeing patients on July 3rd at the office, located at 26137 La Paz Rd, Suite 140, Mission Viejo, CA 92691.

Key Points: 
  • MISSION VIEJO, Calif., July 18, 2023 /PRNewswire-PRWeb/ -- Pain Medicine Associates (PMA) is pleased to announce that interventional pain management specialist Andres Betts, M.D., has joined the company's Mission Viejo, California pain management practice.
  • He began seeing patients on July 3rd at the office, located at 26137 La Paz Rd, Suite 140, Mission Viejo, CA 92691.
  • Dr. Betts is an innovative, board-certified, fellowship trained interventional pain management physician that specializes in the diagnosis and treatment of pain disorders.
  • He founded the Pain Clinic in Bellingham, Washington and Pain MD Medical Associates in San Clemente, California.

Ovid Therapeutics Expands Its Scientific Leadership Team & Appoints Chief Strategy Officer

Retrieved on: 
Wednesday, June 28, 2023
Columbia University, SAB, Seizure, Postdoctoral researcher, Epilepsy, GABA, Pain disorder, Meg, Corporate Affairs, Doctor of Philosophy, MB, Rockefeller University, CSO, G&A, Research, CMO, CNS, GlaxoSmithKline Pharmaceuticals, Thought, Retirement, Syneos Health, ROCK2, Hemangioma, Vertex Pharmaceuticals, KCC2, Medical device, Pharmaceutical industry, Management

“We are excited as Zhong and Manoj respectively assume research and development leadership of Ovid’s focused pipeline of potential first-in-class and best-in-class CNS programs,” said Jeremy Levin, D. Phil, MB BChir, Chairman and Chief Executive Officer of Ovid Therapeutics.

Key Points: 
  • “We are excited as Zhong and Manoj respectively assume research and development leadership of Ovid’s focused pipeline of potential first-in-class and best-in-class CNS programs,” said Jeremy Levin, D. Phil, MB BChir, Chairman and Chief Executive Officer of Ovid Therapeutics.
  • Prior to joining Ovid, Dr. Zhong served in senior leadership and scientific roles at Generation Bio, Wave Life Sciences, Vertex Pharmaceuticals, and GlaxoSmithKline Pharmaceuticals.
  • Dr. Zhong will partner closely with Dr. Manoj Malhotra who is taking on an expanded role as Chief Medical Officer.
  • In addition to deepening its bench of scientific leadership, Ovid expanded the role of Meg Alexander to the position of Chief Strategy Officer.

Impel Pharmaceuticals to Present New Real-World Data for Trudhesa® at the 65th Annual Scientific Meeting of the American Headache Society

Retrieved on: 
Thursday, June 15, 2023
Aurora, Pain disorder, Medical Affairs Bureau, Migraine, Cleveland Clinic, IMPL, Headache (journal), AHS, Research, Pharmacy, DHE, DSM-IV codes, Poster, Patient, Nausea, Cleveland, Bladelet (impeller), Headache, Sleep, GI, Safety, Pharmaceutical industry, Dihydroergotamine

SEATTLE, June 15, 2023 (GLOBE NEWSWIRE) -- Impel Pharmaceuticals (NASDAQ: IMPL), a commercial-stage biopharmaceutical company with a mission to develop transformative therapies for people suffering from diseases with high unmet medical needs, today announced it will present new real-world data adding to the growing body of evidence supporting Trudhesa® (dihydroergotamine mesylate [DHE]) nasal spray (0.725 mg per spray) as an effective acute therapy for migraine management. The findings will be featured in two poster presentations during the 65th Annual Scientific Meeting of the American Headache Society (AHS), taking place June 15-18, 2023, in Austin, Texas.

Key Points: 
  • The findings will be featured in two poster presentations during the 65th Annual Scientific Meeting of the American Headache Society (AHS), taking place June 15-18, 2023, in Austin, Texas.
  • Importantly, an increase in antinausea medications was not observed following Trudhesa use, whereas these medications are commonly used with DHE administered intravenously.
  • “DHE has an established safety and efficacy profile, often providing long-lasting relief for even the toughest of migraine attacks.
  • However, until Trudhesa, nasal delivery options couldn’t reach the upper nasal space, where DHE can be rapidly absorbed,” said Zubair Ahmed, M.D., a headache specialist and neurologist at the Cleveland Clinic.

PharmaTher Submits FDA Meeting Package to Discuss 505(b)(2) Pathway for New Drug Application of KETARX™ (Ketamine) On-Body Pump System

Retrieved on: 
Tuesday, February 7, 2023
Irritation, Mental health, Ketamine, Degenerative disease, Food, PTSD, Hospital, CMC, IV, Risk, NDA, Depression, CSE, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Relaxation, Anesthesia, Pain disorder, Maintenance, Pain, Pharmaceutical industry, Medical device

Fabio Chianelli, CEO of PharmaTher, commented: “We are in a position to meet with the FDA to obtain guidance on the final requirements for our KETARX™ On-Body Pump System to support a new drug application under the 505(b)(2) pathway.

Key Points: 
  • Fabio Chianelli, CEO of PharmaTher, commented: “We are in a position to meet with the FDA to obtain guidance on the final requirements for our KETARX™ On-Body Pump System to support a new drug application under the 505(b)(2) pathway.
  • In the short term, we will seek FDA approval for our KETARX™ On-Body Pump System in general anesthesia and sedation for surgical procedures.
  • Subsequently, should the KETARX™ On-Body Pump System obtain FDA approval, it will allow the Company to leverage its regulatory package and clinical data to expand to mental health (i.e.
  • There can be no assurance that the FDA will support any potential request for an expedited path to approval or further development for KETARX™ On-Body Pump System.

Irwin Naturals Looks to Add to Florida Foothold, Expanding Chain of Healthcare Clinics

Retrieved on: 
Tuesday, November 1, 2022
Awareness, FRA, Cannabis, PTSD, The Wall Street Journal, CEO, Health, Florida Gulf Coast University, CBD, CSE, GLOBE, Ketamine, LLC, Family, Bloomberg, Pain disorder, APRN, Safety, CFO, Anxiety, Learning, Investor, Company, Post-traumatic stress disorder, Board of directors, OTC, Canadian Securities Exchange, Depression, CRNA, Medicine, Pharmaceutical industry, Bank, Finance

The clinic will be incorporated into Irwin Naturals Emergence, a fast-growing national chain offering psychedelic mental healthcare that already includes five clinics in Florida.

Key Points: 
  • The clinic will be incorporated into Irwin Naturals Emergence, a fast-growing national chain offering psychedelic mental healthcare that already includes five clinics in Florida.
  • Klee Irwin, CEO of Irwin Naturals said, Were moving fast to realize our goal of being first in building the biggest chain of psychedelic mental-healthcare clinics in the country.
  • The company invited those clinics that met its criteria to join the family so to speak and become part of Irwin Naturals Emergence, which is a wholly owned subsidiary of Irwin Naturals.
  • Irwin Naturals Emergence has already reached agreements with clinics located in seven different states, including five clinics it previously acquired in Florida .

Avadel Presents New Real-World Data Describing Demographic Characteristics and Comorbidities of Patients with Narcolepsy at ANA 2022

Retrieved on: 
Monday, October 24, 2022
People, Paced Auditory Serial Addition Test, Female, Dysthymia, Migraine, Mayo Clinic, Prevalence, American Neurological Association, Narcolepsy, Compartment syndrome, Carpal tunnel syndrome, Places in the United States with notable demographic characteristics, ANA, Fibromyalgia, Patient, Sleep, Depression, Mortality, Myalgia, Partnership, Nasdaq, Pain disorder, Sex, Pain, GLOBE, Anxiety, Literature, Insomnia, Center, Pain scale, Obstructive sleep apnea, Health information management, Pharmaceutical industry, Retail

DUBLIN, Ireland, Oct. 24, 2022 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today announced new real-world data identifying demographic characteristics and comorbidities of patients with narcolepsy. These results, along with three encore presentations, were presented at the American Neurological Association (ANA) annual meeting, taking place October 22-25, 2022.

Key Points: 
  • These results, along with three encore presentations, were presented at the American Neurological Association (ANA) annual meeting, taking place October 22-25, 2022.
  • These data mark the first time we are analyzing aggregate information about patients with narcolepsy receiving treatment within the Mayo Clinic system over the last 20 years.
  • The retrospective analysis was conducted in partnership with Mayo Clinic and real-world evidence vendor nFerence using electronic health records to identify people living with narcolepsy between 2000 and 2020 and describe their demographic characteristics and comorbidities.
  • A matched control cohort was used to account for differences in demographics, care utilization and severity of illness.

PharmaTher Provides Business Highlights and Releases Audited Annual Financials for Fiscal Year Ended May 31, 2022

Retrieved on: 
Thursday, September 29, 2022
Psilocybin, Safety, Pain disorder, Trial of the century, Administration, Amyotrophic lateral sclerosis, FDA, Pharmacokinetics, Anesthesia, OTCQB, Company, Status epilepticus, Treatment, Amyotrophy, Mental health, International Financial Reporting Standards, Process, CSE, Pain, Board of directors, Commercial, ALS, GLOBE, SEDAR, Food, International, Depression, Mission statement, Pharmaceutical industry, Generic drug, Ketamine

TORONTO, Sept. 29, 2022 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on developing and commercializing novel uses and delivery forms of ketamine to treat mental health, neurological and pain disorders, today released business highlights and audited financial results for its fiscal year ended May 31, 2022. All amounts in this press release are in Canadian dollars. 

Key Points: 
  • Fabio Chianelli, Chief Executive Officer of PharmaTher, said, We had achieved important clinical and business milestones that will pave the way for PharmaTher to potentially become a commercial-stage company in 2023.
  • To support our commercial objectives, we aim to file abbreviated new drug applications with the FDA for our ketamine injectable products for anesthesia and procedural sedation.
  • Cash and cash equivalents ($9,154,906) and Investment ($2,966,667) for a total of $12,121,573 as of May 31, 2022.
  • PharmaThers product portfolio consists of KETARX (ketamine) delivered by intravenous injection, intradermal microneedle patch, and subcutaneous pump administration.