Sedation

DGAP-News: PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS

Retrieved on: 
Thursday, January 28, 2021
Drugs, Chemical compounds, Organic compounds, GABAA receptor positive allosteric modulators, Anesthesia, Benzodiazepines, Pyridines, Remimazolam, General anesthetics, Sedation, Procedural sedation and analgesia, Ketamine, remimazolam, PAION

PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS

Key Points: 
  • PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS
    The issuer is solely responsible for the content of this announcement.
  • BYFAVO(TM) was approved by the U.S. Food and Drug Administration (FDA) on 2 July 2020 for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
  • Remimazolam is approved in the U.S. and China for procedural sedation and in Japan and South Korea for general anesthesia.
  • In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019.

Elegant Smiles is recognized as a 2021 Top Patient Rated Brookhaven Dentist by Find Local Doctors

Retrieved on: 
Tuesday, January 26, 2021
Health care, Medical specialties, Health sciences, Dentistry, Dentist, Dental, Sedation, Papoose board, Special needs dentistry

Their extensive skill set and patient-centered approach to dental care have largely contributed to the practice's recognition as a 2021 Top Patient-Rated Brookhaven Dentist by Find Local Doctors .

Key Points: 
  • Their extensive skill set and patient-centered approach to dental care have largely contributed to the practice's recognition as a 2021 Top Patient-Rated Brookhaven Dentist by Find Local Doctors .
  • Find Local Doctors is a credible online directory that helps consumers locate reputable physicians and dentists in their geographical area.
  • Elegant Smiles has earned the Top Patient Rated Dentist award due to the numerous outstanding reviews and five-star ratings left by patients.
  • Elegant Smiles offers patients the convenience of emergency dental care, same-day appointments, in-house financing plans and sedation dentistry.

PharmaTher Signs Exclusive Worldwide License Agreement for Patented Ketamine Formulation Targeting Mental Health, Neurological and Pain Disorders

Retrieved on: 
Tuesday, January 19, 2021
Drugs, Psychoactive drugs, Neurochemistry, NMDA receptor antagonists, General anesthetics, Amines, Chloroarenes, Nicotinic antagonists, Ketamine, Sedation, Mental disorder

We believe KETABET has the potential to change the way mental health, neurological and pain disorders will be treated for the hundreds of millions of people globally who are suffering from these debilitating conditions, said Fabio Chianelli, CEO of PharmaTher.

Key Points: 
  • We believe KETABET has the potential to change the way mental health, neurological and pain disorders will be treated for the hundreds of millions of people globally who are suffering from these debilitating conditions, said Fabio Chianelli, CEO of PharmaTher.
  • We are pursuing the clinical development of KETABET to overcome the current limitations of ketamine and to unlock the known potential therapeutic value of ketamine for FDA approval.
  • Ketamine was approved by the FDA in 1970 and is clinically used for analgesia, sedation, and anesthetic induction.
  • These range from the common problems such as aging, cancer, infectious diseases, mental disorders, occupational diseases, to health policy.

Study on Patented Non-Opioid MKO Melt® Reported in Leading Peer-Reviewed Anesthesia Journal

Retrieved on: 
Thursday, December 3, 2020
Medical specialties, Drugs, Clinical medicine, Anesthesia, General anesthetics, GABAA receptor positive allosteric modulators, Analgesics, Synthetic opioids, Fentanyl, Midazolam, Sedation

NASHVILLE, Tenn., Dec. 03, 2020 (GLOBE NEWSWIRE) -- Harrow Health, Inc. (NASDAQ: HROW) today announced that a study featuring its patented MKO Melt formulation has been published in the American Association of Nurse Anesthetists (AANA) Journal.

Key Points: 
  • NASHVILLE, Tenn., Dec. 03, 2020 (GLOBE NEWSWIRE) -- Harrow Health, Inc. (NASDAQ: HROW) today announced that a study featuring its patented MKO Melt formulation has been published in the American Association of Nurse Anesthetists (AANA) Journal.
  • The IRB-approved study compared the effectiveness and equivalency of a sublingual compounded non-opioid MKO Melt troche during monitored anesthesia sedation with traditional IV sedation for maintaining comfort in patients undergoing cataract surgery.
  • One group received IV sedation consisting of fentanyl and midazolam (n=54) and the other group received sublingual MKO Melt (n=53).
  • The authors of the study reported no financial relationships with any commercial related entity connected to the study.

Sedana Medical submits market approval application for the drug Sedaconda

Retrieved on: 
Friday, November 27, 2020
Drugs, Health sciences, Medical specialties, Anesthesia, Sedation, Isoflurane, Drug discovery

STOCKHOLM, Nov. 27, 2020 /PRNewswire/ -- Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care.

Key Points: 
  • STOCKHOLM, Nov. 27, 2020 /PRNewswire/ -- Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care.
  • The application is the starting point of the review process of Sedaconda in 15 of the EU member states, including Norway.
  • If all goes well, Sedana Medical expects an approval in the second half of 2021.
  • The market approval application is based on the strong results in Sedana Medical's pivotal phase III study, SED-001.

Sedana Medical submits market approval application for the drug Sedaconda

Retrieved on: 
Friday, November 27, 2020
Drugs, Health sciences, Medical specialties, Anesthesia, Sedation, Drug discovery, Isoflurane

STOCKHOLM, Nov. 27, 2020 /PRNewswire/ -- Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for market approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care.

Key Points: 
  • STOCKHOLM, Nov. 27, 2020 /PRNewswire/ -- Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has submitted an application for market approval for the drug candidate Sedaconda (isoflurane), formerly known as IsoConDa, for inhaled sedation in intensive care.
  • The application is the starting point of the review process of Sedaconda in 15 of the EU member states, including Norway.
  • If all goes well, Sedana Medical expects an approval in the second half of 2021.
  • The market approval application is based on the strong results in Sedana Medical's pivotal phase III study, SED-001.

DGAP-News: PAION REPORTS POSITIVE REMIMAZOLAM TOPLINE DATA IN EU PHASE III TRIAL IN GENERAL ANESTHESIA

Retrieved on: 
Thursday, November 19, 2020
Chemical compounds, Medical specialties, GABAA receptor positive allosteric modulators, Organic compounds, Benzodiazepines, Pyridines, Remimazolam, General anesthetics, Propofol, Sedation, Procedural sedation and analgesia, Anesthesia

- Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol

Key Points: 
  • - Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol
    - EU Phase III program completed; data to serve as basis for MAA submission in general anesthesia
    Aachen (Germany), 19 November 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces positive topline data from the pivotal remimazolam EU Phase III trial in general anesthesia.
  • Assuming approval in procedural sedation, PAION plans to submit an extension of the marketing authorization for remimazolam for general anesthesia.
  • In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
  • In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.

DGAP-News: PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST NINE MONTHS OF 2020

Retrieved on: 
Wednesday, November 11, 2020
Drugs, Psychoactive drugs, Chemical compounds, GABAA receptor positive allosteric modulators, Benzodiazepines, Pyridines, Remimazolam, General anesthetics, Euphoriants, Sedation, Food and Drug Administration, Drug Enforcement Administration

In the U.S., the FDA (Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.

Key Points: 
  • In the U.S., the FDA (Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.
  • In October 2020, the Drug Enforcement Administration (DEA) designated BYFAVO(TM) as a Schedule IV medicine, which was a prerequisite for launch.
  • The overall evaluation of opportunities and risks has not changed significantly in the first nine months of 2020.
  • PAION confirms its financial outlook for the current fiscal year announced on 12 August 2020 with the publication of the half-year results for 2020.

Natick Family Dental Offers Nitrous & Sedation Dentistry to help Patients overcome "Dental Phobia"

Retrieved on: 
Tuesday, October 20, 2020
MetroWest, Geography of Massachusetts, Natick, Massachusetts, Framingham, Massachusetts, Dentist, Sedation, Ashland, Massachusetts, Natick Center station, Dental fear, MetroWest Regional Transit Authority, Minuteman Library Network

NATICK, Mass., Oct. 20, 2020 /PRNewswire/ -- Natick Family Dental is pleased to introduce sedation dentistry into its practice.

Key Points: 
  • NATICK, Mass., Oct. 20, 2020 /PRNewswire/ -- Natick Family Dental is pleased to introduce sedation dentistry into its practice.
  • To significantly reduce, if not eliminate, the fear and anxiety associated with dental treatment, Natick Family Dental is now offering sedation dentistry.
  • "The option to receive sedation has changed the lives of many of our patients enabling them to overcome their dental fears and to have a positive clinical experience," says Dr. Rachana Vora, President of Natick Family Dental.
  • Natick Family Dental is a multi-specialty dental practice based in Natick, MA serving neighboring communities of Wellesley, Framingham, Wayland, Needham, Ashland, Sherborn, Dover, Holliston, and Southborough.

AnaConDa from Sedana Medical reviewed by NICE in UK

Retrieved on: 
Wednesday, October 7, 2020
Anesthesia, Sedation, Intensive care medicine, Anesthetic, Anesthesiology

"The report confirms AnaConDa and its technology as an innovation and supports it as an alternative to intravenous sedation.

Key Points: 
  • "The report confirms AnaConDa and its technology as an innovation and supports it as an alternative to intravenous sedation.
  • They are NICE advice, designed to support NHS and social care commissioners and staff who are considering using new medical devices, and other medical or diagnostic technologies.
  • Sedana Medical AB (publ) has developed and sells the medical device AnaConDa for the administration of volatile anaesthetics.
  • Through a combination of AnaConDa and the candidate drug IsoConDa (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated intensive care patients.