Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Tuesday, May 21, 2024

Patent granted for first new forms of MDMA, clearing path to a potential FDA approval

 I'm assuming your competent? doctor has already secured supplies for your recovery as needed.

  • MDMA (9 posts to November 2012)

    ecstasy (19 posts to November 2012)

     

Since there is a 23% chance of stroke survivors getting PTSD what is your doctor's treatment plan?

 

The latest here:

Patent granted for first new forms of MDMA, clearing path to a potential FDA approval

Key takeaways:

  • The FDA is currently reviewing MDMA HCI for approval and a decision is expected in August.
  • Terran Biosciences will pursue a rapid approval pathway for its patented new form of MDMA, pending the FDA decision.

Terran Biosciences has been awarded a U.S. patent for the world’s first new salts and polymorphs of MDMA, pharmaceutical compositions using these forms, and the method of use for treatment of PTSD, according to a company press release.

Terran Biosciences now holds the only composition of matter patent of a new form of MDMA, according to the release.

MDMA molecule
If the FDA approves MDMA HCI, Terran Biosciences will pursue a rapid 505(b)(2) approval pathway for its new form of MDMA (MDMA hemifumarate).
Image: Adobe Stock

To date, clinical trials of MDMA have been limited to using older forms of MDMA hydrochloride (MDMA HCI). MDMA HCI was submitted for FDA approval on the 505(b)(1) path and is currently under review. A decision is expected in August. If the FDA approves MDMA HCI, Terran Biosciences said it will pursue a rapid 505(b)(2) approval pathway for its new form of MDMA (MDMA hemifumarate).

Terran Biosciences could use this regulatory pathway to bring its MDMA product to market approximately 5 years from the date of the MDMA HCI approval. This would involve leveraging existing safety and efficacy data from completed MDMA trials to bypass any listing in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for the older MDMA HCI.

The company said in the release that it hopes to increase the affordability and global accessibility of MDMA, and that it has developed a new GMP manufacturing process with this goal in mind.

“With this new breakthrough, we are committed to bringing affordable and accessible MDMA treatment options to patients with PTSD,” Sam Clark, MD, PhD, inventor of the patent and Terran Biosciences’ founder and CEO, said in the release. “We believe this new form of MDMA will enable us to bypass any potential future Orange Book listing, eliminating the potential for a 30-month stay that could otherwise delay the entry of generic MDMA HCl. MDMA-assisted psychotherapy could revolutionize the treatment of PTSD and Terran Biosciences will ensure that affordable MDMA is not delayed.”

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