FDA Approves Fasoracetam as ADHD Treatment

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Fasoracetam ADHD FDA Approval

Fasoracetam Approved as ADHD Treatment

Remember all the notes following descriptions of Fasoracetam when it was first coming around as a “potential ADHD treatment”, but the FDA delaying approval, and being stuck at stage 3 trials for what seems like 20 years? Check this out. It seems to have finally received the FDA's approval as a “non-stimulant ADHD Treatment”:

Jul. 19, 2018 9:34 AM ET
About: Aevi Genomic Medicine, … (GNMX)
By: Niloofer Shaikh, SA News Editor 

Aevi Genomic Medicine (GNMX) has received positive feedback from the FDA provisionally indicating that AEVI-004 is a novel co-crystal of lead drug AEVI-001 (fasoracetam) with enhanced physical and chemical properties.

FDA provisionally agreed existing AEVI-001 toxicology and pathology studies are acceptable to support clinical development with AEVI-004, with minimal preclinical bridging studies

AEVI-001 is an oral non-stimulant pan-selective activator/modulator of mGluRs for the potential treatment of ADHD and other glutamate receptor-linked neuropsychiatric disorders.

AEVI-004 is also an oral non-stimulant pan-selective activator/modulator of mGluRs, but with several distinct advantages over AEVI-001, including better stability and better manufacturability owing to a significantly higher melting point.

AEVI-004 is expected to have composition of matter patents extending to 2039 and should be listed as a novel drug substance in the FDA Orange Book.

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That is very interesting to hear. Pretty much what happened is that they formulated an “enhanced” version with fasoracetam being the lead drug and is said to be further improving the effects.

The FDA finally are convicned and now GNMX will be manufacturing this new bumped up Fasoracetam version, and will have composition patent “extending until 2039”.

I am curious to see how is this going to unfold. I am actually ADHD and have used Fasoracetam for a while to experiment and measure its effectiveness on me both for ADHD and GABA regulation. I haven't seen tremendous effect but it was notable enough to be worthy of further examination.

Realization: I'll be getting my Fasoracetam through insurance soon enough instead of paying for it!

Any thoughts on this?

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