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Dr. Bob is Robert Hsiung, MD,
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Posted by Hugh on March 19, 2019, at 21:44:19
On Tuesday, federal regulators approved the second new antidepressant this month after 35 years of little progress combatting the disease.
An injection called Zulresso, the new drug treats postpartum depression (PPD).
PPD occurs after childbirth and is thought to affect roughly one in every 6 women.
This month's two new approved drugs could work faster and last longer than previous medications.
Federal regulators have just given the green light to a second new kind of antidepressant this month, after decades of little progress combating the disease.
The US Food and Drug Administration on Tuesday approved an injection branded Zulresso that is made by biotech company Sage Therapeutics. The drug, known as brexanalone, treats people who experience depression after giving birth, a condition known as postpartum depression (PPD).
"This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option," Tiffany Farchione, the FDA's acting director in the division of psychiatry products, said in a statement.
About two weeks ago, the FDA approved a treatment for severe depression called esketamine from Johnson & Johnson.
In contrast to the past 35 years of depression medications, neither of the new drugs is a pill. One is a nasal spray and the other is an injection.
Both drugs take new tacks to treating depression that have not been seen by other approved medications. Instead of homing in on the brain's serotonin network -- as all the available medications have for the past four decades -- the new drugs zero in on unique parts of the brain thought to affect our mood.
Because of that, reviewers hope the drugs will offer faster and longer-asting solutions -- primarily for people who've tried and failed to see benefits with existing medications.
Sage's drug affects the brain's Gaba network, which is believed to play a role in anxiety. It was created for mothers with postpartum depression. PPD is estimated to affect as many as 400,000 Americans each year.
Johnson & Johnson's drug, esketamine, is inspired by ketamine and works on a brain system known as the NMDA system. It's designed to treat severe depression.
One of the biggest potential upsides of Sage's drug is the fact that it would not need to be taken daily like a traditional antidepressant. It also appears to work quickly, taking effect within hours, unlike current depression pills, which can take weeks to start working. The effects of Zulresso may last as far out as 30 days, the period of time researchers analyzed for the company's clinical trials.
The company is also studying a pill version of its new injectable in a broader set of mental illnesses including major depression and bipolar disorder. Analysts expect that drug, known only as Sage-217, to have blockbuster appeal for the 16 million Americans with severe depression unrelated to childbirth.
The official approval for brexanolone follows a favorable vote from outside experts convened by the FDA last fall. In November, the panel voted 17-1 in favor of the treatment, which they decided carried more benefits than risks for patients. Still, the new drug has important risks and side-effects.
Analysts and clinicians said they were hopeful about the new approval for several reasons. They believe it adds options for a disease that currently has no approved medications. They also expect the news to bode well for Sage's related drug -- the oral pill called 217 that's in an earlier stage of research but targets the same part of the brain as the injection.
Together, Zulresso and 217 "have the potential to change the treatment paradigm for treating mood disorders," wrote Yatin Suneja, a senior biotech analyst with investment firm Guggenheim, in a report circulated last month. Suneja added that the firm expected the two drugs to generate sales in the range of $3-5 billion across diseases including major depression, PPD, and potentially bipolar disorder.
Assuming that 217 gets approved as well, Sage sees both drugs as helping to provide more options to people with mental illness.
Unlike brexanolone, 217 could be taken by mouth without the need for specialty clinics. Plus, 217 is being studied for use in a wider range of brain diseases including major depressive disorder, bipolar disorder, and insomnia.
"The possibility of having something that impacts the Gaba system is attractive because if you were to launch it tomorrow, there's likely going to be lots of patients who've failed with anything that's available," Paul Matteis, the managing director of biotech research with brokerage firm Stifel, told Business Insider.
And like Sage's injection, the oral pill may act faster than traditional medications and also not require daily dosing. In clinical trials looking at patients who took the drug once, its effects appeared to last as long as four weeks.
That's something that Matteis said sounds like it would be "preferred by most patients [over] having to take something indefinitely."
"We're trying to change the paradigm," Cloonan said. "We want patients to take this medicine when they need it, not when they dont."
Complete article:
Posted by Hugh on March 21, 2019, at 0:24:34
In reply to FDA approves Zulresso, posted by Hugh on March 19, 2019, at 21:44:19
SAGE-217, the oral version of Zulresso, is expected to be approved by the FDA this spring or summer. If this happens, any physician in the US will be allowed to prescribe SAGE-217 off-label for major depressive disorder, bipolar disorder, anxiety, PTSD, insomnia.
Posted by SLS on March 21, 2019, at 13:45:09
In reply to Re: FDA approves Zulresso, posted by Hugh on March 21, 2019, at 0:24:34
Hi, Hugh.
> SAGE-217, the oral version of Zulresso, is expected to be approved by the FDA this spring or summer. If this happens, any physician in the US will be allowed to prescribe SAGE-217 off-label for major depressive disorder, bipolar disorder, anxiety, PTSD, insomnia.
Thanks for the update.
SAGE-217 = Zuranolone
- Sage Therapeutics
I just got done looking at this drug. It appears to work the same way as Zulresso. It acts as a GABA-A receptor positive modulator.
Have you seen anyone use pregnanolone?
- Scott
Posted by Lamdage22 on March 21, 2019, at 13:51:19
In reply to Re: FDA approves Zulresso » Hugh, posted by SLS on March 21, 2019, at 13:45:09
What about men?
Posted by beckett2 on March 21, 2019, at 20:54:48
In reply to FDA approves Zulresso, posted by Hugh on March 19, 2019, at 21:44:19
I didn't see this post when I posted below. But I read this is given through IV for 60 hours, during which the woman must be closely monitored.
Posted by Hugh on March 21, 2019, at 23:51:15
In reply to Re: FDA approves Zulresso, posted by Lamdage22 on March 21, 2019, at 13:51:19
> What about men?
This SAGE-217 clinical trial for major depressive disorder accepted all sexes.
Posted by Hugh on March 21, 2019, at 23:56:30
In reply to Re: FDA approves Zulresso » Hugh, posted by beckett2 on March 21, 2019, at 20:54:48
> I didn't see this post when I posted below. But I read this is given through IV for 60 hours, during which the woman must be closely monitored.
It's pretty impractical. But at least that 60-hour infusion keeps a lot of the women in remission for at least four weeks, and perhaps permanently.
SAGE-217 is taken orally once a day for two weeks, and it also puts women and men into remission for at least four weeks, and perhaps much longer.
Posted by Hugh on March 23, 2019, at 0:45:54
In reply to Re: FDA approves Zulresso » Hugh, posted by SLS on March 21, 2019, at 13:45:09
> Have you seen anyone use pregnanolone?
This clinical trial for major depressive disorder is just for women. but it won't be completed until late 2020:
https://clinicaltrials.gov/ct2/show/NCT03645096
This trial for bipolar disorder enrolled both women and men:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4200497/
Posted by Lamdage22 on June 5, 2019, at 8:11:10
In reply to Re: FDA approves Zulresso » SLS, posted by Hugh on March 23, 2019, at 0:45:54
Hmm i may try this SAGE-217. It might be tough to convince my doctor! Are there any interactions expected?
I am having a tough time.
Posted by Lamdage22 on June 5, 2019, at 8:26:09
In reply to Re: FDA approves Zulresso, posted by Lamdage22 on June 5, 2019, at 8:11:10
What about driving and anxiety with SAGE-217?
This is the end of the thread.
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