Nov 6, 2019 11:53 PM
The Second Psychopharmacology Revolution
https://www.psychologytoday.com/us/blog/...revolution
EXCERPT: . . . During the first psychopharmacology revolution, antipsychotics, antidepressants, and antianxiety agents were discovered. At the same time, lithium was shown to be effective in treating bipolar disorder. These medications provided psychiatrists with treatments to help patients hospitalized in asylums as well as outpatients suffering from milder symptoms.
[...] The field of psychiatry may now be entering a second psychopharmacology revolution. Over the past 20 years, ketamine, a medication already approved as an anesthetic, has been found to have rapid and substantial antidepressant effects when administered intravenously at lower-than-anesthetic doses. Ketamine’s antidepressant effects occur within hours and can last up to a week or more following a single infusion. New ketamine-like medications are under investigation ... A second major new advance in psychopharmacology involves a group of drugs called neurosteroids (or neuroactive steroids). The structure and function of neurosteroids are very different than either the older antidepressants or ketamine.
[...] The ketamine-based drugs and the neurosteroid-based drugs are revolutionary in terms of the rapidity of their antidepressant effects and their mechanisms of action. Other medications with truly different mechanisms are also in the early stages of investigation. It is possible that the 15 years between 2015 and 2030 will be as remarkable in terms of psychopharmacology as the 1955-1970 era. (MORE - details)
Alzheimer's drug approved in China delivers a surprise but also questions
https://www.statnews.com/2019/11/04/a-ne...questions/
INTRO: Chinese regulators have granted conditional approval to an Alzheimer’s drug that is derived from seaweed, potentially shaking up the field after years of clinical failures involving experimental therapies from major drug companies. The announcement over the weekend has been met with caution as well as an eagerness from clinicians and others to see full data from the drug maker, Shanghai Green Valley Pharmaceuticals. The company said its drug, Oligomannate, improved cognitive function in patients with mild to moderate Alzheimer’s compared to placebo in a Phase 3 trial, with benefits seen in patients as early as week four and persisting throughout the 36 weeks of the trial.
It has been almost two decades since any Alzheimer’s drug was approved. Oligomannate has received scant attention in the United States during its development. Although full data on the drug have not yet been made available, the conditional approval by regulators means Oligomannate, also known as GV-971, will on the market in China by the end of the year, Green Valley said. The company will have to submit additional research on the mechanism of the drug and its long-term safety and effectiveness to the country’s National Medical Products Administration, Reuters reported. Green Valley also said it would launch a global Phase 3 trial next year in hopes of filing for approval in other countries as well.
“It’s good to see that drug regulators in China are prioritizing emerging treatments for Alzheimer’s, but we do still need to see more evidence that this drug is safe and effective,” Carol Routledge, the director of research at Alzheimer’s Research UK, said in a statement. “For any potential drug to gain a stamp of approval by regulators in the UK, we’ll need to see larger trials in countries around the world to back up the evidence from China.”
Outside experts said they would want the full data to show exactly how cognitive function improved for patients on the drug versus those on placebo, and how meaningful that was in the patients’ lives... (MORE)
https://www.psychologytoday.com/us/blog/...revolution
EXCERPT: . . . During the first psychopharmacology revolution, antipsychotics, antidepressants, and antianxiety agents were discovered. At the same time, lithium was shown to be effective in treating bipolar disorder. These medications provided psychiatrists with treatments to help patients hospitalized in asylums as well as outpatients suffering from milder symptoms.
[...] The field of psychiatry may now be entering a second psychopharmacology revolution. Over the past 20 years, ketamine, a medication already approved as an anesthetic, has been found to have rapid and substantial antidepressant effects when administered intravenously at lower-than-anesthetic doses. Ketamine’s antidepressant effects occur within hours and can last up to a week or more following a single infusion. New ketamine-like medications are under investigation ... A second major new advance in psychopharmacology involves a group of drugs called neurosteroids (or neuroactive steroids). The structure and function of neurosteroids are very different than either the older antidepressants or ketamine.
[...] The ketamine-based drugs and the neurosteroid-based drugs are revolutionary in terms of the rapidity of their antidepressant effects and their mechanisms of action. Other medications with truly different mechanisms are also in the early stages of investigation. It is possible that the 15 years between 2015 and 2030 will be as remarkable in terms of psychopharmacology as the 1955-1970 era. (MORE - details)
Alzheimer's drug approved in China delivers a surprise but also questions
https://www.statnews.com/2019/11/04/a-ne...questions/
INTRO: Chinese regulators have granted conditional approval to an Alzheimer’s drug that is derived from seaweed, potentially shaking up the field after years of clinical failures involving experimental therapies from major drug companies. The announcement over the weekend has been met with caution as well as an eagerness from clinicians and others to see full data from the drug maker, Shanghai Green Valley Pharmaceuticals. The company said its drug, Oligomannate, improved cognitive function in patients with mild to moderate Alzheimer’s compared to placebo in a Phase 3 trial, with benefits seen in patients as early as week four and persisting throughout the 36 weeks of the trial.
It has been almost two decades since any Alzheimer’s drug was approved. Oligomannate has received scant attention in the United States during its development. Although full data on the drug have not yet been made available, the conditional approval by regulators means Oligomannate, also known as GV-971, will on the market in China by the end of the year, Green Valley said. The company will have to submit additional research on the mechanism of the drug and its long-term safety and effectiveness to the country’s National Medical Products Administration, Reuters reported. Green Valley also said it would launch a global Phase 3 trial next year in hopes of filing for approval in other countries as well.
“It’s good to see that drug regulators in China are prioritizing emerging treatments for Alzheimer’s, but we do still need to see more evidence that this drug is safe and effective,” Carol Routledge, the director of research at Alzheimer’s Research UK, said in a statement. “For any potential drug to gain a stamp of approval by regulators in the UK, we’ll need to see larger trials in countries around the world to back up the evidence from China.”
Outside experts said they would want the full data to show exactly how cognitive function improved for patients on the drug versus those on placebo, and how meaningful that was in the patients’ lives... (MORE)