- |||||||||| Olinvyk (oliceridine) / Trevena, Jiangsu NHWA Pharma
Review, Journal: Oliceridine and its potential to revolutionize GI endoscopy sedation. (Pubmed Central) - Sep 18, 2020
For an anesthesia provider, the administration of oliceridine can eliminate the need for drugs such as fentanyl that add to the respiratory depressant properties of propofol. As a result, oliceridine has the potential to render the sedation for GI endoscopy procedures both safe and cost-effective.
- |||||||||| ByFavo (remimazolam) / PAION, Cosmo Pharma, Mundipharma, Pharmascience, Acacia Pharma
Clinical, P3 data, Journal: The efficacy and safety of remimazolam tosylate versus propofol in patients undergoing colonoscopy: a multicentered, randomized, positive-controlled, phase III clinical trial. (Pubmed Central) - Sep 12, 2020
For safety assessment, total treatment-emergent adverse events were decreased in remimazolam group compared to propofol group (P<0.001); specifically, administration site pain (P<0.001), increased bilirubin (P=0.019), decreased respiratory rate (P<0.001) and decreased SpO (P<0.001) were less frequent in remimazolam group compared with propofol group. In conclusion, remimazolam tosylate is non-inferior in sedation efficacy while safer than propofol in patients undergoing colonoscopy.
- |||||||||| ByFavo (remimazolam) / PAION, Cosmo Pharma, Mundipharma, Pharmascience, Acacia Pharma, Olinvyk (oliceridine) / Trevena, Jiangsu NHWA Pharma
Review, Journal, HEOR: Medical, Political, and Economic Considerations for the Use of MAC for Endoscopic Sedation: Big Price, Little Justification? (Pubmed Central) - Jul 17, 2020
As a result, in spite of years of research and efforts of many august societies, the logjam of balancing cost and justification of propofol sedation has continued. We hope that recent approval of remimazolam, a novel benzodiazepine, and potential approval of oliceridine, a novel short-acting opioid, might be able to contain the cost without compromising the quality of sedation.
- |||||||||| ByFavo (remimazolam) / PAION, Cosmo Pharma, Mundipharma, Pharmascience, Acacia Pharma, ONO / 2745
Clinical, PK/PD data, Journal: Pharmacokinetics and Pharmacodynamics of Remimazolam (CNS 7056) after Continuous Infusion in Healthy Male Volunteers: Part I. Pharmacokinetics and Clinical Pharmacodynamics. (Pubmed Central) - Jul 9, 2020
We hope that recent approval of remimazolam, a novel benzodiazepine, and potential approval of oliceridine, a novel short-acting opioid, might be able to contain the cost without compromising the quality of sedation. Remimazolam was characterized by a pharmacokinetic-pharmacodynamic profile with fast onset, fast recovery, and moderate hemodynamic side effects.
- |||||||||| ByFavo (remimazolam) / PAION, Cosmo Pharma, Mundipharma, Pharmascience, Acacia Pharma
Review, Journal: Remimazolam; a role for anaesthesia/ sedation? (Pubmed Central) - Jul 9, 2020
Definitive studies are awaited. As a benzodiazepine, remimazolam could be evaluated as an anticonvulsant and for intensive care sedation.
- |||||||||| remifentanil / Generic mfg.
Review, Journal: Soft drugs in anesthesia: remifentanil as prototype to modern anesthetic drug development. (Pubmed Central) - Jul 9, 2020
As a benzodiazepine, remimazolam could be evaluated as an anticonvulsant and for intensive care sedation. With succinylcholine as the historical forerunner and remifentanil as the modern prototype, the soft drug paradigm continues to hold promise for the future of anesthesia drug development.
- |||||||||| ByFavo (remimazolam) / PAION, Cosmo Pharma, Mundipharma, Pharmascience, Acacia Pharma
[VIRTUAL] Correlating Depth of Sedation with Vital Signs and Adverse Events in Bronchoscopy (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_6737;
There was no clinically meaningful correlation between vital signs and depth of sedation as assessed by MOAA/S score. Even when patients transitioned into deep sedation, there was no difference in vital signs except for a slight increased incidence of hypotension, which did not adversely affect clinical outcomes.
- |||||||||| Barhemsys (intravenous amisulpride) / Acacia Pharma
Journal: An overview of intravenous amisulpride as a new therapeutic option for the prophylaxis and treatment of postoperative nausea and vomiting. (Pubmed Central) - May 29, 2020
The article is based on a Medline, ClinicalTrials.gov, and Cochrane Library search for studies on amisulpride conducted so far.Expert opinion: Promising clinical results on Barhemsys®, an intravenous formulation of amisulpride, make it a potential future drug of choice from the dopamine receptor antagonist group, replacing droperidol after its safety concerns. Amisulpride's success on the market will mostly be determined by its cost-effectiveness and it will likely find a brighter use on the US-market, where the black-box warning led to droperidol's withdrawal, while in many European countries, droperidol is still being used as an antiemetic.
- |||||||||| ByFavo (remimazolam) / PAION, Cosmo Pharma, Mundipharma, Pharmascience, Eagle Pharma
Trial completion, Surgery: Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery (clinicaltrials.gov) - May 27, 2020
P3, N=469, Completed,
Amisulpride's success on the market will mostly be determined by its cost-effectiveness and it will likely find a brighter use on the US-market, where the black-box warning led to droperidol's withdrawal, while in many European countries, droperidol is still being used as an antiemetic. Recruiting --> Completed
- |||||||||| moxifloxacin / Generic mfg., Alcon, Lupin, Avelox (moxifloxacin) / Bayer
Journal: Diurnal Profile of the QTc Interval Following Moxifloxacin Administration. (Pubmed Central) - Apr 15, 2020
The findings suggested that moxifloxacin prolongs QTc beyond its elimination from the blood circulation. This is of relevance to current concentration-effect modeling approaches, which presume the absence of hysteresis effects.
- |||||||||| remimazolam (ONO-2745) / PAION, Cosmo, Mundipharma, Pharmascience
Correlating Depth of Sedation with Vital Signs and Adverse Events in Bronchoscopy (PENNSYLVANIA CONVENTION CENTER, Hall D-E (200 Level), Area D) - Mar 15, 2020 - Abstract #ATS2020ATS_9445;
There was no clinically meaningful correlation between vital signs and depth of sedation as assessed by MOAA/S score. Even when patients transitioned into deep sedation, there was no difference in vital signs except for a slight increased incidence of hypotension, which did not adversely affect clinical outcomes.
- |||||||||| remifentanil / Generic mfg., remimazolam (ONO-2745) / PAION, Cosmo, Mundipharma, Pharmascience, ketamine / Generic mfg.
Journal: Procedural sedation in ambulatory anaesthesia: what's new? (Pubmed Central) - Mar 2, 2020
Even when patients transitioned into deep sedation, there was no difference in vital signs except for a slight increased incidence of hypotension, which did not adversely affect clinical outcomes. Procedural sedation deserves to have high degree of attention for further developments, both from a scientific and pragmatic point of view, as the practice is very diversified and growing.
- |||||||||| ketamine / Generic mfg.
Review, Journal: Recent Developments in Drugs for GI Endoscopy Sedation. (Pubmed Central) - Jan 11, 2020
In the interim, many drug combinations such as propofol-dexmedetomidine and propofol-ketamine are improving the safety without compromising the quality of sedation. This review attempts to discuss the new drug innovations and drug combinations of existing sedatives for the benefit of readers.
- |||||||||| ByFavo (remimazolam) / PAION, Cosmo Pharma, Mundipharma, Pharmascience, Eagle Pharma
Trial completion date, Trial primary completion date, Surgery: Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery (clinicaltrials.gov) - Oct 8, 2019
P3, N=500, Recruiting,
In an exploratory analysis, it demonstrated a shorter onset of action and faster neuropsychiatric recovery than midazolam. Trial completion date: Aug 2020 --> Mar 2020 | Trial primary completion date: Aug 2020 --> Mar 2020
- |||||||||| ByFavo (remimazolam) / PAION, Cosmo Pharma, Mundipharma, Pharmascience, Eagle Pharma
Trial completion date, Trial primary completion date, Surgery: Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery (clinicaltrials.gov) - Sep 30, 2019
P3, N=500, Recruiting,
Trial completion date: Aug 2020 --> Mar 2020 | Trial primary completion date: Aug 2020 --> Mar 2020 Trial completion date: Jun 2019 --> Aug 2020 | Trial primary completion date: Jun 2019 --> Aug 2020
- |||||||||| Barhemsys (intravenous amisulpride) / Eagle Pharma
Trial completion: Study of APD421 With and Without Ondansetron (clinicaltrials.gov) - Oct 1, 2018
P1, N=30, Completed,
Moreover, there was no evidence for a harmful effect of remimazolam exposure on the integrity and metabolic activity of in vitro cultivated primary human hepatocytes. Enrolling by invitation --> Completed
- |||||||||| Barhemsys (intravenous amisulpride) / Eagle Pharma
Enrollment open: Study of APD421 With and Without Ondansetron (clinicaltrials.gov) - Jul 16, 2018
P1, N=30, Enrolling by invitation,
Enrolling by invitation --> Completed Not yet recruiting --> Enrolling by invitation
- |||||||||| ByFavo (remimazolam) / PAION, Cosmo Pharma, Mundipharma, Pharmascience, Eagle Pharma
Trial completion, Trial primary completion date: A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy (clinicaltrials.gov) - Aug 1, 2017
P3, N=431, Completed,
Not yet recruiting --> Enrolling by invitation Recruiting --> Completed | Trial primary completion date: Jun 2017 --> Mar 2017
- |||||||||| Barhemsys (intravenous amisulpride) / Eagle Pharma
Trial completion, Enrollment change, Trial primary completion date: Study of APD421 as PONV Treatment (Prior Prophylaxis) (clinicaltrials.gov) - Jan 24, 2017
P3, N=705, Completed,
Recruiting --> Completed | Trial primary completion date: Apr 2016 --> Dec 2016 Recruiting --> Completed | N=580 --> 705 | Trial primary completion date: Oct 2016 --> Jan 2017
- |||||||||| ByFavo (remimazolam) / PAION, Cosmo Pharma, Mundipharma, Pharmascience, Eagle Pharma
Trial primary completion date: A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy (clinicaltrials.gov) - Oct 11, 2016
P3, N=420, Recruiting,
Recruiting --> Completed | N=580 --> 705 | Trial primary completion date: Oct 2016 --> Jan 2017 Trial primary completion date: Jun 2016 --> Jun 2017
- |||||||||| Barhemsys (intravenous amisulpride) / Eagle Pharma
Trial primary completion date: Study of APD421 as PONV Treatment (Prior Prophylaxis) (clinicaltrials.gov) - Aug 8, 2016
P3, N=580, Recruiting,
Trial primary completion date: Jun 2016 --> Jun 2017 Trial primary completion date: Jul 2016 --> Oct 2016
- |||||||||| Barhemsys (intravenous amisulpride) / Eagle Pharma
Enrollment open: Study of APD421 as PONV Treatment (Prior Prophylaxis) (clinicaltrials.gov) - Apr 6, 2016
P3, N=580, Recruiting,
Recruiting --> Completed | Trial primary completion date: Dec 2015 --> Apr 2016 Not yet recruiting --> Recruiting
- |||||||||| ByFavo (remimazolam) / PAION, Cosmo Pharma, Mundipharma, Pharmascience, Eagle Pharma
Enrollment change, Trial termination, Surgery: Study of the Efficacy and Safety of Remimazolam in General Anesthesia in Adults Undergoing Cardiac Surgery (clinicaltrials.gov) - Mar 23, 2016
P3, N=25, Terminated,
Not yet recruiting --> Recruiting N=530 --> 25 | Recruiting --> Terminated; Poor recruitment
- |||||||||| Barhemsys (intravenous amisulpride) / Eagle Pharma
Enrollment open, Enrollment change: Study of APD421 as PONV Treatment (no Prior Prophylaxis) (clinicaltrials.gov) - Jan 5, 2016
P3, N=580, Recruiting,
N=530 --> 25 | Recruiting --> Terminated; Poor recruitment Not yet recruiting --> Recruiting | N=338 --> 580
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