SAGE Therapeutics — CNS Disorders

Discussion in 'Research News' started by Autumnly, Jul 11, 2018.

    1. Autumnly
      Wishful

      Autumnly Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      2013
      Cause of Tinnitus:
      Noise-induced
      Sage Therapeutics
      "Sage Therapeutics is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing novel medicines to transform the lives of patients with life-altering central nervous system (CNS) disorders."

      SAGE-217
      "SAGE-217 is a novel, selective, next generation GABAA positive allosteric modulator that shares similar pharmacology properties to brexanolone. We are initially developing SAGE-217 as a once-daily, oral therapy for treatment of various CNS disorders."

      Sage Announces Pivotal Phase 3 Trial Status for SAGE-217 in Major Depressive Disorder and Postpartum Depression based on FDA Breakthrough Therapy Meeting
      • Expedited SAGE-217 development plan to support potential NDA submission for MDD and PPD
      • Previously completed placebo-controlled study in MDD considered as pivotal; initiation of one additional Phase 3 pivotal trial anticipated in 2H of 2018.
      • Ongoing study in PPD designated as pivotal; results expected in 4Q 2018.
      • If successfully developed, SAGE-217 has the potential to be the first durable, rapid-acting, oral, short-course treatment for MDD and PPD
      Further Exploitation of GABAA and NMDA Receptors
      "We are exploring additional potential products in a variety of CNS disorders based on modulation of both the GABAA and NMDA receptors. In addition to our products focused on SE, other GABAA mediated CNS disorders upon which we believe our approach can have a material impact include Rett syndrome, Dravet syndrome, fragile X syndrome, anxiety, depression, sleep disorders, mania, tremor, tinnitus and post-traumatic stress disorder."

      "Enhancing GABA pharmacologically (benzodiazepines) or physiologically (more Typer II or somatosensory inputs) could quiet tinnitus" - Dr. Robert Aaron Levine
      Dr. Robert Aaron Levine's Tinnitus...
       
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    2. Contrast
      No Mood

      Contrast Member Benefactor Hall of Fame

      Location:
      Clown World
      Tinnitus Since:
      late 2017
      Cause of Tinnitus:
      noise injury
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    3. Greg Sacramento

      Greg Sacramento Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      04/2011
      Cause of Tinnitus:
      Syringing + Somatic tinnitus from dental work
      @Contrast I also posted what @Autumnly posted, but I'm glad that she reposted it because I can't post more as I recently bought shares 3 weeks ago. With that I think that the share price is too high. I'm going to sell tomorrow.
       
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    4. PetitGarsTimide
      Caffeine

      PetitGarsTimide Member

      Location:
      Twin Peaks
      Tinnitus Since:
      2016
      Cause of Tinnitus:
      Dumb teenager who listened to loud music everytime
      SAGE-217 is the new xanax
       
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    5. AUTHOR
      AUTHOR
      Autumnly
      Wishful

      Autumnly Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      2013
      Cause of Tinnitus:
      Noise-induced
      There’s also brexanolon (formerly known as SAGE-547) which is administered as an intravenous therapy designed to correct imbalances in GABA signaling within the brain. It’s an acute interventional treatment for postpartum depression and already through phase 3. The FDA has accepted the filing of a New Drug Application and granted Priority Review status.

      But I have no idea which drug (brexanolon or SAGE-217) would be more effective in treating tinnitus (if they can actually treat tinnitus).
       
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    6. Paulmanlike

      Paulmanlike Member Benefactor Hall of Fame

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Noise
      Does anybody know if this drug being developed by SAGE working on correcting the GABA has helped tinnitus?
       
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    7. Greg Sacramento

      Greg Sacramento Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      04/2011
      Cause of Tinnitus:
      Syringing + Somatic tinnitus from dental work
      @Paulmanlike
      The company won't comment on that. Maybe they will with other design therapy.

      All drugs of this nature will probably require IV injection as this one with approval in link below for 60 hours. Will healthcare consider it cost effective to treat tinnitus with IV injection long term. This may be the reason for SAGE holding back on a direct GABA treatment for tinnitus. It's important as an awareness cause to have hospitals and doctors realize that tinnitus is a severe condition.


      https://www.fiercebiotech.com/biotech/fda-panel-backs-sage-s-postpartum-depression-drug-17-1-vote
       
      Last edited: Nov 7, 2018
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    8. Paulmanlike

      Paulmanlike Member Benefactor Hall of Fame

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Noise
      SAGE has got a Buy rating, I saw you previously bought stock in the company, did you sell it in the end or you holding on?
       
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    9. AUTHOR
      AUTHOR
      Autumnly
      Wishful

      Autumnly Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      2013
      Cause of Tinnitus:
      Noise-induced
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    10. Greg Sacramento

      Greg Sacramento Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      04/2011
      Cause of Tinnitus:
      Syringing + Somatic tinnitus from dental work
      SAGE is in completion of raising 575 million to add to the hundreds of millions that they already have in the bank.

      In the last year they have been putting together what appears to be a solid patent library of compounds for tinnitus.

      Neuroactive steroids, compositions, and uses thereof

      Three of their many patents


      (1) Provided herein are 19-nor C3, 3-disubstituted steroids of Formula (I): and pharmaceutically acceptable thereof; wherein R1, R2, R3, and R4 are as defined herein, and A is a heteroaryl ring system comprising 3 or 4 nitrogens as defined herein. Such compounds are contemplated useful for the prevention and treatment of a variety of CNS-related conditions, for example, traumatic brain injury, vascular diseases, substance withdrawal syndromes, and tinnitus.

      19-nor neuroactive steroids and methods of use thereof

      (2) Provided herein are 3,3-disubstituted 19-nor-steroidal compounds according to Formula (1): and pharmaceutical compositions thereof. Such compounds are contemplated useful for the prevention and treatment of a variety of CNS-related conditions, for example, pain, traumatic brain injury, vascular diseases, withdrawal syndromes, tinnitus, . Brain Cognition Diseases Mood Disorder Personality Disorder Sleep Disorder Tinnitus Traumatic Brain Injury Vascular Diseases

      (3) Neuroactive steroids, compositions, and uses thereof
      Described herein are steroids of Formula (I): and pharmaceutically acceptable salts thereof; wherein R1, R2a, R2b, R3, R4, R5a, R5b, R6, and Z are as defined herein. Such compounds are contemplated useful for the prevention and treatment of a variety of CNS-related conditions, for example, pain, traumatic brain injury, vascular diseases, substance abuse disorders and/or withdrawal syndromes, and tinnitus

      Behind '547, Sage is developing a spate of CNS therapies that modulate the brain's GABAA and NMDA receptors, including preclinical treatments for depression, essential tremor, tinnitus and pain.

      Last year I posted a form where one could just type 'please develop a tinnitus drug as soon as possible'.

      Their depression drug is a non benzo with hardly any taper needed.
      In my opinion they could raise another 2 to 3 billion from Wall Street with no problems.

      Awareness - Go to the money that has research and the patents. Someone that can save us and not some treatment that might help a small percentage.
       
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    11. Arseny
      Wishful

      Arseny Member

      Tinnitus Since:
      2018
      Cause of Tinnitus:
      Possibly from problems with blood flow
      So this might come out in 3 months?
      Is anyone going to try it?
      I imagine you have to travel to USA to try it?
       
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    12. Greg Sacramento

      Greg Sacramento Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      04/2011
      Cause of Tinnitus:
      Syringing + Somatic tinnitus from dental work
      Your reference is to a depression non benzo non taper neuro depression drug. This is a first in class and most have thought that it was impossible. I have no idea if it will help with tinnitus and the company won't discuss this as it's not part of label.

      They are doing neuro research on tinnitus and pain, but in their conference call they are at present focusing on other neuro disease and conditions. Can they do the impossible with a tinnitus drug even though it may take years to develop? They have important patents that may slow others down with tinnitus research.

      I think that this is our only hope as tinnitus is a neuro brain disease. I just think that most to all other treatments will just make money for those with these procedures and for those within these communication areas.

      There's a few with physical tinnitus of more than one year that do see their tinnitus fade due to physical treatments. A few more will receive lowering, but healthcare often doesn't investigate and use research study. Studies have recently come out and said that certain tests are needed for physical tinnitus which include a FONAR stand up MRI for the neck and 3D cone beam scan for jaw.
       
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    13. Paulmanlike

      Paulmanlike Member Benefactor Hall of Fame

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Noise
      @Greg Sacramento can you please provide links to SAGE Therapeutics where they say they are doing research into tinnitus drug treatments?
       
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    14. Jazzer

      Jazzer Member Benefactor Ambassador Hall of Fame Advocate

      Location:
      UK
      Tinnitus Since:
      1/1995
      Cause of Tinnitus:
      Noise
      This is the only real hope of a breakthrough that I personally have.
      The idea of gizmos relaying electric currents to already damaged nerve cells sounds very dodgy to me; it could have the potential for further damage I reckon.
      It all looks like a ‘hit and miss - trial and error’ set up, rather than genuine science.
      Drugs can effectively treat headaches, migraines, Parkinson’s, anxiety, and tons of other conditions.
      Before Greg brought this up I hadn’t seen any reference to it?
      We just have to hope.....x
       
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    15. Greg Sacramento

      Greg Sacramento Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      04/2011
      Cause of Tinnitus:
      Syringing + Somatic tinnitus from dental work
      Besides with tinnitus patent registrations it mentioned in the other SAGE thread.
      They are doing some serious tinnitus patent collecting and they have a strong BOD presence in the tinnitus space.
      Jeff Jonas
      https://www.sagerx.com/about-us/our-team/

      With this, I would think that a Phase I will be coming in a few years if not sooner.
      I personally will not make an investment because EPS earnings per share is expected to drop going into 2020. From about -2.00 to over -10.00. That's would be a big drop in earnings per share.
       
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    16. Paulmanlike

      Paulmanlike Member Benefactor Hall of Fame

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Noise
      @Greg Sacramento

      It seems they have a bunch of patents looking for a nail to hit with a hammer.

      I contacted SAGE regarding their patents and asked if they had any plans to initiate any trials for tinnitus.

      As expected they said they cannot discuss this unfortunately, and gave me links to their clinical trials and pipeline.
       
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    17. shasta0863

      shasta0863 Member

      Tinnitus Since:
      11/2007
      Cause of Tinnitus:
      Noise Induced
      Any update to this?
       
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    18. AUTHOR
      AUTHOR
      Autumnly
      Wishful

      Autumnly Member Podcast Patron Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      2013
      Cause of Tinnitus:
      Noise-induced
      • SAGE-217 is still in Phase 3
      • Sage Therapeutics Announces U.S. Drug Enforcement Administration Scheduling of ZULRESSO™ (brexanolone) Injection
        • was approved by the U.S. Food and Drug Administration (FDA) on March 19, 2019
        • first and only treatment specifically approved for postpartum depression (PPD)
        • The Company expects to launch ZULRESSO in late June as planned.
        • ZULRESSO is administered via continuous intravenous (IV) infusion for 2.5 days under the supervision of healthcare providers in sites of care certified under the ZULRESSO Risk Evaluation and Mitigation Strategy (REMS) program. The one-time infusion offers the potential for rapid resolution of depressive symptoms of PPD.
      • Still don't know if these drugs could help with tinnitus
       
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    19. TheDanishGirl
      Sad

      TheDanishGirl Member Benefactor Hall of Fame

      Location:
      Denmark
      Tinnitus Since:
      05/2017 (H since 06/2017)
      Cause of Tinnitus:
      long term noise exposure (headphones), maybe some stress.
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    20. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      That video on fusiform cells was awesome. They mention electrical stimulation to alter the imbalance, isn’t that what Susan Shore is attempting? My first few months with tinnitus I can remember taking GABA pills as the anxiety hit a ceiling, I believe it lowered it and brought my back to earth for a little while. Maybe she is on to something. I hope they don’t give up on the drug, more drugs the better in the direction of possible treatment, not sure how it would help depression though. I would think something that stimulates you might be better but what do I know? I’m no doctor.
       
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    21. InNeedOfHelp

      InNeedOfHelp Member

      Tinnitus Since:
      08/2021
      Cause of Tinnitus:
      MRI Scan
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    22. Nick47

      Nick47 Member Benefactor

      Location:
      UK
      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
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    23. juliob
      Confused

      juliob Member

      Location:
      Brazil
      Tinnitus Since:
      03/2018
      Cause of Tinnitus:
      Antidepressants / Loud Sound Exposure
      In theory, would those undergoing benzo tapering or benzo withdrawal be playing with fire taking this?
       
    24. Watasha
      No Mood

      Watasha Member Podcast Patron Benefactor Ambassador Advocate

      Tinnitus Since:
      03/2018
      Cause of Tinnitus:
      Unknown
      Inclusion criteria for the new study:

      Participant is willing and able to safely discontinue the use of central nervous system (CNS) depressants (e.g., opioids and benzodiazepines), antidepressants, anticonvulsants, CNS stimulants (with the exception of caffeine), aspirin, other nonsteroidal anti inflammatory drugs, and aminoglycosides at least 14 days or 5 half-lives (whichever is longer) prior to receiving IP and through completion of the study

      An Open-Label Study Evaluating Brexanolone in Adults With Tinnitus
       
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    25. Travis Henry
      Cynical

      Travis Henry Member

      Location:
      Dallas,TX
      Tinnitus Since:
      10/2021
      Cause of Tinnitus:
      1 Moderna Vac, Noise and stress I guess, its killing me
      Where is the hype on this one?
       
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    26. Nick47

      Nick47 Member Benefactor

      Location:
      UK
      Tinnitus Since:
      2015
      Cause of Tinnitus:
      Viral/noise
      I think the lack of hype is out of partial surprise (it has come out of nowhere) and the fact they have not put forward a scientific rationale for this.

      The active component has been on the market for around 3 years, given for post natal depression. It's been effective but highly expensive.

      @Greg Sacramento will be the one to ask judging by his previous contributions to this thread in terms of scientific rationale.

      But a piece written recently states:

      Brexanolone (Zulresso) is a mixture of allopregnanolone and sulfobutylether-beta-cyclodextrin, acts as an anti-depressant. It is formulated as injectable solution for intravenous route of administration. Zulresso is indicated for the treatment of postpartum depression (PPD) in adults. Zulresso is indicated for the treatment of postpartum depression in patients 15 years of age and older.

      SAGE-547 (SGE-120) is under development for the treatment of severe postpartum depression (PPD), Post-traumatic stress disorder (PTSD), psychosis, tinnitus and alcohol addiction. The drug candidate is administered through intravenous injection. The drug candidate is a formulation of allopregnanolone, a metabolite of progesterone formed in the CNS. It is a positive GABAA receptor allosteric modulator. The drug candidate is based on positive and negative allosteric modulator (PANAM) chemistry platform. The PANAM technology comprises of non-benzodiazepine approach that regulates allosteric modulation of GABAA receptor in the positive (PAM) direction. It was also under development for the treatment of super-refractory status epilepticus (SE), traumatic brain injury, major depressive disorder, Alzheimer's disease, mild cognitive impairment, COVID-19 related acute respiratory distress syndrome (ARDS) and essential tremor.​

      The trial starts in a matter of weeks...
       
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    27. IndyMLVC

      IndyMLVC Member

      Location:
      NYC
      Tinnitus Since:
      2009
      Cause of Tinnitus:
      Unknown
      I was asked to do a study on a medication like this (I don't think this was it). The idea of being off ALL antidepressants/anxiety meds plus edibles on the off chance that I don't get the placebo is too much for me. Then the fact that, IF you get the real thing AND it works, they take it away afterwards would frustrate me to no end.
       
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