We’re glad to see you’re enjoying ReachMD…
but how about a more personalized experience?
Announcer:
You're listening to The Drug Report on ReachMD, hosted by Linda Bernstein, Pharm.D., Clinical Professor on the Volunteer Faculty of the School of Pharmacy, University of California, San Francisco.
Dr. Bernstein:
Welcome to The Drug Report and an update on news pertaining to dexmedetomidine hydrochloride, a sedative used in anesthesia. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist that is associated with sedative and analgesic sparing effects, reduced delirium and agitation, perioperative sympatholysis, cardiovascular stabilizing effects, and preservation of respiratory function. The product is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures.
Dexmedetomidine Hydrochloride is the hydrochloride salt form of dexmedetomidine, an imidazole derivate and active d-isomer of medetomidine with analgesic, anxiolytic and sedative activities. Dexmedetomidine selectively binds to and activates presynaptic alpha-2 adrenoceptors located in the brain, thereby inhibiting the release of norepinephrine from synaptic vesicles. This leads to an inhibition of postsynaptic activation of adrenoceptors, which inhibits sympathetic activity, thereby leading to analgesia, sedation and anxiolysis.
The most common side effects of dexmedetomidine hydrochloride injection are hypotension, bradycardia and dry mouth. This drug is listed in the FDA Drug Shortage Database.
Dexmedetomidine has been the feature of a few news reports in recent months pertaining to approval of additional generic forms of the drug and a drug recall.
An abbreviated new drug application approval for Aurobindo Pharma’s dexmedetomidine hydrochloride in 0.9% sodium chloride injection was announced by the US Food & Drug Administration on December 7.
The product is a therapeutic equivalent generic version of Hospira's Precedex in 0.9% Sodium Chloride Injection. The product will be launched in January 2021.
The approved product has an estimated market size of $228 million for the twelve months ending October 2020 according to IQVIA.
This approval follows that of Dr. Reddy’s Laboratories Ltd. and its subsidiaries who announced on September 25th the launch of their generic version of Precedex®.
Now we move on to a November 19 voluntary recall by Fresenius Kabi USA of a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot.
To date, no adverse drug experience reports have been received for the recalled lot. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in a potentially life-threatening allergic reaction.
Fresenius Kabi is notifying its distributors and customers by letter and asking them to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product.
Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi. The recall letter and response form are available at https://www.fresenius-kabi.com/us/pharmaceutical-product-updates.
Customers with questions regarding this recall may contact the company. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
For The Drug Report, I’m Pharmacist, Dr. Linda Bernstein.
Announcer:
To access this episode and others from The Drug Report, visit ReachMD.com/drugreport, where you can be part of the knowledge. Thanks for listening.
Ready to Claim Your Credits?
You have attempts to pass this post-test. Take your time and review carefully before submitting.
Good luck!
A sedative commonly used in anesthesia, dexmedetomidine hydrochloride has been the subject of many news reports over the past few months. But most recently, the FDA announced approval for Aurobindo Pharma’s dexmedetomidine hydrochloride in 0.9% sodium chloride injection. In this episode of The Drug Report, Dr. Linda Bernstein reviews recent approvals of dexmedetomidine hydrochloride on initially intubated and mechanically ventilated patients.
Published December 17, 2020
Announcer:
You're listening to The Drug Report on ReachMD, hosted by Linda Bernstein, Pharm.D., Clinical Professor on the Volunteer Faculty of the School of Pharmacy, University of California, San Francisco.
Dr. Bernstein:
Welcome to The Drug Report with a special focus on the COVID-19 pandemic.
Researchers all over the world are trying many novel approaches to conquering the Novel Coronavirus, cause of the current deadly pandemic. Let’s look at a few of these approaches and what they may mean for today and potential viral mutations going forward.
Celltrion Group, through a partnership with the Korea Centers for Disease Control and Prevention (KCDC), narrowed their top neutralizing antibody candidates to 14 of the most powerful and will begin cell-line development. They hope to roll out mass production of the therapeutic antibody and, together with the KCDC, conduct efficacy and toxicity testing in mice and non-human primates. Ki-Sung Kwon, Head of R&D Unit at Celltrion said, “These antibodies can recognize multiple epitopes, thus increasing the probability of nonspecific antigen binding. We anticipate moving to first-in-human clinical trials in July. We are also on track with the development of a ‘super antibody’ or ‘an antibody cocktail’ and the launch of a rapid self-testing diagnostic kit in the summer of this year.”
Regeneron is trying two approaches to COVID-19. Based on recent clinical data from studies in China with another IL-6 inhibitor, they believe there is a potential role for Kevzara® (sarilumab) in the treatment of severe and critical hospitalized patients with COVID-19. Together with Sanofi, they are conducting controlled clinical trials to evaluate Kevzara in this setting on an investigational basis.The global trial program is now enrolling patients at medical centers in the United States, Italy, Spain, Germany, France, Canada, and Russia.
Regeneron is also looking to develop a novel multi-antibody cocktail that can be administered as prophylaxis before exposure to the SARS-CoV-2 virus or as treatment for those already infected. Hundreds of virus-neutralizing, fully human antibodies have been isolated from the company's mice which have been genetically modified to have a human immune system. Regeneron has also isolated antibodies from humans who have recovered from COVID-19 in order to maximize the pool of potentially potent antibodies. From this large pool of candidates, Regeneron will select the top two antibodies for a 'cocktail' treatment based on potency and binding ability to the SARS-CoV-2 spike protein, as well as other desirable qualities. Using a multi-antibody approach allows for targeting of different parts of the virus and may help protect against multiple viral variants. They used similar technologies to rapidly develop a treatment for Ebola virus infection, which is currently under review by the U.S. Food and Drug Administration.
Eli Lilly, in conjunction with the National Institute of Allergy and Infectious Diseases, is planning to test rheumatoid arthritis drug Olumiant (baricitinib), a Janus kinase (JAK) inhibitor, in patients hospitalized with COVID-19. The study is starting this month in the U.S., and investigators plan expanded testing to Europe and Asia.
Meanwhile, Lilly also unveiled plans to test an investigational monoclonal antibody, LY3127804, in pneumonia patients hospitalized with COVID-19. That trial is starting later this month in the U.S.
Roche has announced that the US Food and Drug Administration (FDA) has formally approved its phase 3 trial of Actemra in severely ill COVID-19 patients who have been hospitalized with pneumonia. Actemra (tocilizumab) – an interleukin-6 inhibitor – has already been approved in China for the treatment of patients infected with the novel coronavirus disease who have developed serious lung damage and also have elevated levels of IL-6 in the blood. Previous research has suggested that elevated IL-6, a biomarker for inflammation and a high-level immune response, is associated with a higher mortality in people with community-acquired pneumonia.
Japanese company Fujifilm has launched a Phase II clinical trial of its influenza drug Avigan (favipiravir) to treat COVID-19 patients in the US. It will also be tested on 80 patients at Hadassah Hospital in Israel. Approved in 2014 in Japan, Avigan specifically targets RNA polymerase required for influenza virus replication. This mechanism is also expected to have an antiviral effect on the novel coronavirus, which is a single-stranded RNA virus similar to influenza and requires viral RNA polymerase. For the new study in the US, around 50 coronavirus patients will be enrolled at Brigham and Women’s Hospital, Massachusetts General Hospital, and the University of Massachusetts Medical School. The trial will evaluate the drug’s safety and efficacy as a potential COVID-19 therapy.
Finally, Johnson & Johnson announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020 and by rapid scaling of the company’s manufacturing capacity they hope to provide a global supply of more than one billion doses of a vaccine. The company expects to initiate human clinical trials of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a pace they state is substantially accelerated in comparison to the typical vaccine development timeframe.
For more information on COVID-19 treatment and prevention studies, see clinicaltrials.gov.
For The Drug Report, I’m pharmacist Dr. Linda Bernstein.
Announcer:
To access this episode and others from The Drug Report, visit ReachMD.com/drugreport, where you can be part of the knowledge. Thanks for listening.
A sedative commonly used in anesthesia, dexmedetomidine hydrochloride has been the subject of many news reports over the past few months. But most recently, the FDA announced approval for Aurobindo Pharma’s dexmedetomidine hydrochloride in 0.9% sodium chloride injection. In this episode of The Drug Report, Dr. Linda Bernstein reviews recent approvals of dexmedetomidine hydrochloride on initially intubated and mechanically ventilated patients.
Published December 17, 2020
Announcer:
You're listening to The Drug Report on ReachMD, hosted by Linda Bernstein, Pharm.D., Clinical Professor on the Volunteer Faculty of the School of Pharmacy, University of California, San Francisco.
Dr. Bernstein:
Welcome to The Drug Report with a special focus on the COVID-19 pandemic.
Researchers all over the world are trying many novel approaches to conquering the Novel Coronavirus, cause of the current deadly pandemic. Let’s look at a few of these approaches and what they may mean for today and potential viral mutations going forward.
Celltrion Group, through a partnership with the Korea Centers for Disease Control and Prevention (KCDC), narrowed their top neutralizing antibody candidates to 14 of the most powerful and will begin cell-line development. They hope to roll out mass production of the therapeutic antibody and, together with the KCDC, conduct efficacy and toxicity testing in mice and non-human primates. Ki-Sung Kwon, Head of R&D Unit at Celltrion said, “These antibodies can recognize multiple epitopes, thus increasing the probability of nonspecific antigen binding. We anticipate moving to first-in-human clinical trials in July. We are also on track with the development of a ‘super antibody’ or ‘an antibody cocktail’ and the launch of a rapid self-testing diagnostic kit in the summer of this year.”
Regeneron is trying two approaches to COVID-19. Based on recent clinical data from studies in China with another IL-6 inhibitor, they believe there is a potential role for Kevzara® (sarilumab) in the treatment of severe and critical hospitalized patients with COVID-19. Together with Sanofi, they are conducting controlled clinical trials to evaluate Kevzara in this setting on an investigational basis.The global trial program is now enrolling patients at medical centers in the United States, Italy, Spain, Germany, France, Canada, and Russia.
Regeneron is also looking to develop a novel multi-antibody cocktail that can be administered as prophylaxis before exposure to the SARS-CoV-2 virus or as treatment for those already infected. Hundreds of virus-neutralizing, fully human antibodies have been isolated from the company's mice which have been genetically modified to have a human immune system. Regeneron has also isolated antibodies from humans who have recovered from COVID-19 in order to maximize the pool of potentially potent antibodies. From this large pool of candidates, Regeneron will select the top two antibodies for a 'cocktail' treatment based on potency and binding ability to the SARS-CoV-2 spike protein, as well as other desirable qualities. Using a multi-antibody approach allows for targeting of different parts of the virus and may help protect against multiple viral variants. They used similar technologies to rapidly develop a treatment for Ebola virus infection, which is currently under review by the U.S. Food and Drug Administration.
Eli Lilly, in conjunction with the National Institute of Allergy and Infectious Diseases, is planning to test rheumatoid arthritis drug Olumiant (baricitinib), a Janus kinase (JAK) inhibitor, in patients hospitalized with COVID-19. The study is starting this month in the U.S., and investigators plan expanded testing to Europe and Asia.
Meanwhile, Lilly also unveiled plans to test an investigational monoclonal antibody, LY3127804, in pneumonia patients hospitalized with COVID-19. That trial is starting later this month in the U.S.
Roche has announced that the US Food and Drug Administration (FDA) has formally approved its phase 3 trial of Actemra in severely ill COVID-19 patients who have been hospitalized with pneumonia. Actemra (tocilizumab) – an interleukin-6 inhibitor – has already been approved in China for the treatment of patients infected with the novel coronavirus disease who have developed serious lung damage and also have elevated levels of IL-6 in the blood. Previous research has suggested that elevated IL-6, a biomarker for inflammation and a high-level immune response, is associated with a higher mortality in people with community-acquired pneumonia.
Japanese company Fujifilm has launched a Phase II clinical trial of its influenza drug Avigan (favipiravir) to treat COVID-19 patients in the US. It will also be tested on 80 patients at Hadassah Hospital in Israel. Approved in 2014 in Japan, Avigan specifically targets RNA polymerase required for influenza virus replication. This mechanism is also expected to have an antiviral effect on the novel coronavirus, which is a single-stranded RNA virus similar to influenza and requires viral RNA polymerase. For the new study in the US, around 50 coronavirus patients will be enrolled at Brigham and Women’s Hospital, Massachusetts General Hospital, and the University of Massachusetts Medical School. The trial will evaluate the drug’s safety and efficacy as a potential COVID-19 therapy.
Finally, Johnson & Johnson announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020 and by rapid scaling of the company’s manufacturing capacity they hope to provide a global supply of more than one billion doses of a vaccine. The company expects to initiate human clinical trials of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a pace they state is substantially accelerated in comparison to the typical vaccine development timeframe.
For more information on COVID-19 treatment and prevention studies, see clinicaltrials.gov.
For The Drug Report, I’m pharmacist Dr. Linda Bernstein.
Announcer:
To access this episode and others from The Drug Report, visit ReachMD.com/drugreport, where you can be part of the knowledge. Thanks for listening.
Stay current with the best on medical education
