Procedural sedation and analgesia

DGAP-News: PAION ANNOUNCES THAT NMPA ACCEPTS SUBMISSION OF NEW DRUG APPLICATION FOR REMIMAZOLAM BESYLATE IN GENERAL ANESTHESIA BY CHINESE LICENSEE YICHANG HUMANWELL

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Friday, July 9, 2021

Medical specialties, Clinical medicine, Medicine, Anesthesia, Pyridines, Remimazolam, Yichang, Sedation, Procedural sedation and analgesia, Colonoscopy

Aachen (Germany), 09 July 2021 - The specialty pharma company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that its Chinese remimazolam licensee Yichang Humanwell informed PAION that the National Medical Products Administration (NMPA) has accepted their New Drug Application (NDA) for remimazolam besylate in general anesthesia for review.

Key Points:

Aachen (Germany), 09 July 2021 - The specialty pharma company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that its Chinese remimazolam licensee Yichang Humanwell informed PAION that the National Medical Products Administration (NMPA) has accepted their New Drug Application (NDA) for remimazolam besylate in general anesthesia for review.
Yichang Humanwell recently successfully completed the clinical development for remimazolam besylate in general anesthesia.
Dr. Jim Phillips, CEO of PAION AG, commented: "Yichang Humanwell has already made great progress in the China market with Ruima(R) (remimazolam besylate) in procedural sedation, exceeding our initial expectations.
Remimazolam besylate (brand name Ruima(R)) was approved in China for procedural sedation during colonoscopy in July 2020.

DGAP-News: PAION RECEIVES UK MHRA APPROVAL OF BYFAVO (REMIMAZOLAM) FOR PROCEDURAL SEDATION

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Tuesday, June 29, 2021

Anesthesia, Chemical compounds, Organic compounds, GABAA receptor positive allosteric modulators, Pyridines, Remimazolam, Sedation, MHRA, Intensive care unit, Procedural sedation and analgesia, remimazolam, PAION, REMIMAZOLAM, PAION

Aachen (Germany), 29 June 2021 - The specialty pharma company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved Byfavo(R) (remimazolam besylate) in adults for procedural sedation.

Key Points:

Aachen (Germany), 29 June 2021 - The specialty pharma company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved Byfavo(R) (remimazolam besylate) in adults for procedural sedation.
The decision follows the approval of the European Commission in the EU (including European Economic Area (EEA) countries) in March 2021.
Dr. Jim Phillips, CEO of PAION AG, commented: "We are excited that the MHRA has approved Byfavo(R).
In addition to procedural sedation and general anesthesia, intensive care unit (ICU) sedation is another possible indication for remimazolam.

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

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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.

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

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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 REPORTS FINANCIAL RESULTS FOR THE FIRST HALF-YEAR 2020

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Wednesday, August 12, 2020

Chemical compounds, Anesthesia, Organic compounds, GABAA receptor positive allosteric modulators, Medical specialties, Benzodiazepines, Pyridines, Remimazolam, Sedation, Procedural sedation and analgesia, Marketing Authorisation Application, Food and Drug Administration

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

Key Points:

In the U.S., the FDA (U.S. Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.
In July 2020, after market approval of BYFAVOTM, PAION, Cosmo and Acacia agreed to assign the BYFAVOTM license agreement signed in 2016 between Cosmo and PAION to Acacia.
In Europe, PAION is seeking approval for remimazolam in procedural sedation and in general anesthesia.
Procedural sedation: PAION submitted a Marketing Authorization Application (MAA) for procedural sedation to the European Medicines Agency (EMA) in November 2019.

New Blinded Observational Study Shows Greater Depth of Patient Sedation Than Intended During Procedural Colonoscopy

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Monday, August 3, 2020

Biotechnology, Surgery, Medical devices, Health, Pharmaceutical, Medical specialties, Clinical medicine, Medicine, Sedation, Procedural sedation and analgesia, Propofol, Anesthesia, Burst suppression, Electroencephalography, Colonoscopy, General anaesthesia

Anesthesiologists and endoscopists may utilize processed EEG to recognize their institutional practice patterns of procedural sedation with propofol and improve upon it.

Key Points:

Anesthesiologists and endoscopists may utilize processed EEG to recognize their institutional practice patterns of procedural sedation with propofol and improve upon it.
Based on the study results, the researchers concluded, The depth of sedation achieved with anesthesia administered propofol for colonoscopy spans a continuum.
Although providers planned for moderate to deep sedation, processed EEG in this study revealed a substantially greater depth consistent with general anesthesia and even burst suppression.
Further research is required to establish the impact on patient outcomes of anesthetic practices resulting in intraprocedural burst suppression.

DGAP-News: PAION ANNOUNCES U.S. FDA APPROVAL OF REMIMAZOLAM (BYFAVOTM) FOR THE INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION

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Thursday, July 2, 2020

Anesthesia, Chemical compounds, Organic compounds, Sedation, Remimazolam, Procedural sedation and analgesia, remimazolam, PAION

"We are very pleased to announce today the approval of BYFAVOTM in the U.S. for procedural sedation in adult patients," commented Mike Bolinder, Acacia Pharma's CEO.

Key Points:

"We are very pleased to announce today the approval of BYFAVOTM in the U.S. for procedural sedation in adult patients," commented Mike Bolinder, Acacia Pharma's CEO.
In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
In China, licensee Yichang Humanwell filed for market approval in procedural sedation in November 2018 and in South Korea, licensee Hana Pharm filed for market approval for remimazolam in general anesthesia in December 2019.
In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.

Conformal Medical Announces First Left Atrial Appendage Closures Performed Under Conscious Sedation with its CLAAS Technology at AF Symposium 2020

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Wednesday, January 22, 2020

Anesthesia, Medical specialties, Medicine, Cardiac arrhythmia, Sedation, Atrium, Atrial fibrillation, Procedural sedation and analgesia, Left atrial appendage occlusion

NASHUA, N.H., Jan. 22, 2020 (GLOBE NEWSWIRE) -- Conformal Medical, Inc. announced today the presentation of the first left atrial appendage closure (LAAC) cases with its unique CLAAS Technology in patients under conscious sedation without general anesthesia.

Key Points:

NASHUA, N.H., Jan. 22, 2020 (GLOBE NEWSWIRE) -- Conformal Medical, Inc. announced today the presentation of the first left atrial appendage closure (LAAC) cases with its unique CLAAS Technology in patients under conscious sedation without general anesthesia.
Petr Neuzil and Vivek Reddy will present ICE-Guided Implantation of the Conformal Left Atrial Appendage Closure Device: First Clinical Report at the AF Symposium meeting in Washington, D.C., January 23-24.
These first procedures using the conscious sedation protocol were successfully performed at Homolka Hospital in Prague, Czech Republic.
Conformal Medical, Inc. is a medical device company founded in 2016 to develop devices to prevent stroke in patients with atrial fibrillation.

Dentist, Dr. Jacqueline Subka, Relieves Dental Anxiety in Calabasas, CA with Sedation Dentistry

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Thursday, August 1, 2019

Medical specialties, Anesthesia, Medicine, Health, Dentistry, Sedation, Phobias, Dentist, Procedural sedation and analgesia, Nitrous oxide, Dental fear, Outline of dentistry and oral health

CALABASAS, Calif., August 1, 2019 /PRNewswire-PRWeb/ -- Trusted dentist, Dr. Jacqueline Subka, welcomes those who suffer from dental anxiety in Calabasas, CA to receive custom sedation dentistry treatment at her relaxing and comfortable practice in Thousand Oaks, CA.

Key Points:

CALABASAS, Calif., August 1, 2019 /PRNewswire-PRWeb/ -- Trusted dentist, Dr. Jacqueline Subka, welcomes those who suffer from dental anxiety in Calabasas, CA to receive custom sedation dentistry treatment at her relaxing and comfortable practice in Thousand Oaks, CA.
Sedation dentistry uses medications to calm patients who have dental anxiety, enabling them to undergo routine procedures or even combine procedures in order to decrease their number of visits.
Dr. Subka offers four types of sedation dentistry: oral sedation, nitrous oxide, IV conscious sedation and local anesthetic.
Dr. Jacqueline Subka is a general dentist offering personalized dental care for patients in Thousand Oaks, CA since 1999.

Recommendations for Procedural Sedation

Retrieved on:

Thursday, May 10, 2018

Anesthesia, Medicine, Health, Clinical medicine, Sedation, Procedural sedation and analgesia, Capnography, Monitoring

CHICAGO, May 10, 2018 /PRNewswire/ -- The Physician-Patient Alliance for Health & Safety (PPAHS) announced its intention to develop a position statement on recommendations for procedural sedation.

Key Points:

CHICAGO, May 10, 2018 /PRNewswire/ -- The Physician-Patient Alliance for Health & Safety (PPAHS) announced its intention to develop a position statement on recommendations for procedural sedation.
Michael Wong, JD (Founder and Executive Director, PPAHS) explained that such a position statement on recommendations for procedural sedation would encapsulate guidelines and recommendations from leading medical organizations in Canada and the United States:
Mr. Wong noted the interest of the PPAHS in procedural sedation, citing recent clinical education podcasts that PPAHS has produced and released:
" Capnography Monitoring: Yesterday's Luxury, Today's Necessity During Conscious Sedation " which featured an interview with Matt Kurrek, MD, FRCPC (Professor, Department of Anesthesia, University of Toronto) and Richard Merchant, MD, FRCPC (Clinical Professor, University of British Columbia, Department of Anesthesia, Pharmacology & Therapeutics).
The CSA guidelines emphasize the need for end tidal CO2 monitoring during conscious sedation.
Kurrek and Merchant discuss why capnography monitoring may have been considered yesterday's luxury, but is now a necessity during procedures involving conscious sedation.
"