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1. Had a great conversation over Twitter w/ Graham Pechenik, JD @calyxlaw about #psilocybin patents, FDA approvals, & legalization in #Oregon. I appreciate his input & clarification on #psychedelic legal topics. I thought it may be interesting to broadly synthesize the convo here
2. Psilocybin is a Schedule 1 substance. This includes psilocybin mushrooms, psilocybin isolated, and the literal compound itself. While it’s not possible to patent natural psilocybin, methods of obtaining psilocybin may be patented as well as synthetic psilocybin drugs.
3. Further, Schedule 1 deems that psilocybin has no medical benefits and a potential for abuse. However, drug experts dispute this classification, suggesting that Schedule 4 would be more appropriate (Johnson et al., 2018).
4. There are two legal markets coming in action for psilocybin to become available. 
Statewide legalization (ex. Oregon) & 
Medicalization through the FDA (ex. Compass & Usona).
Statewide legalization (ex. Oregon) & Medicalization through the FDA (ex. Compass & Usona).
5. It’s often advertised that ‘psilocybin’ from “magic mushrooms” has been designated a breakthrough therapy by the FDA (i.e. investigational drugs).
These claims may be misleading.
These claims may be misleading.
6. As of today, only Compass Pathways & Usona have FDA “breakthrough” status, so only synthetic psilocybin is being investigated by the FDA (ex. Compass’ patented Polymorph A), not natural psilocybin mushrooms or isolated psilocybin compounds.
7. To conceptualize, I’ll compare with natural #cannabis & Marinol (Dronabinol) as well as SPRAVATO (esketamine) and #MDMA.
With only synthetic psilocybin (ex. polymorph A) being investigated by the FDA, it looks as if psilocybin is following in the steps of cannabis & Marinol
With only synthetic psilocybin (ex. polymorph A) being investigated by the FDA, it looks as if psilocybin is following in the steps of cannabis & Marinol
8. Cannabis is a Schedule 1 drug like psilocybin. As Marinol (Dronabinol) is an FDA approved synthetic THC drug, Compass’ synthetic psilocybin Polymorph A is being investigated for FDA approval.
9. However, FDA approval of a drug containing a synthetic schedule 1 substance does not guarantee the rescheduling of the natural substance (ex. Marinol is Schedule 3, & cannabis is Schedule 1).
10. Thus, if polymorph A becomes FDA approved, then it may go through its own scheduling process. It is possible that psilocybin mushrooms may not be rescheduled.
This process differs from SPRAVATO (esketamine) and investigational MDMA since they are both already synthetic.
This process differs from SPRAVATO (esketamine) and investigational MDMA since they are both already synthetic.
11. Ketamine is in schedule 3, & for MDMA, eventual FDA approval may inspire CSA rescheduling.
Schedule 2 or beyond & FDA approval is necessary for a drug to be prescribed offered by health care providers &covered by insurance. Insurance coverage is not guaranteed (ex. ketamine)
Schedule 2 or beyond & FDA approval is necessary for a drug to be prescribed offered by health care providers &covered by insurance. Insurance coverage is not guaranteed (ex. ketamine)
12. Briefly, the difference between Compass & Usona is that Compass is for-profit and Usona is non-profit. The FDA approval process is tedious & very expensive. Unlike Compass, Usona doesn’t charge researchers for their products, & they didn’t patent. FDA drugs require cGMP.
13. It’s uncertain how the FDA will regulate the set & setting/therapy aspect. Compass recently filed a patent for the cliche setting used, seemingly not novel & includes “soft furniture.”
Protocols are designed by researchers & approved by the sponsor.
Protocols are designed by researchers & approved by the sponsor.
14. In regards to Oregon, it’s a whole new ball game w/ much uncertainty regarding regulations for psilocybin products & services. Psilocybin products may not be FDA approved or follow cGMP. It can’t be covered by insurance or provided by health care providers (MD, NP, PA, RN)
15. For me, personally, I have concerns regarding proper dosing and adequate administration practices. It comes to question who may provide this, where, and how. Will psilocybin administers and designated practitioners need malpractice insurance?
16. w/o rescheduling, research is limited. Its challenging to gauge how statewide legal psilocybin markets may function. There are public health concerns (ex. those w/ insulin dependent diabetes are often excluded in trials). Who’ll be excluded from the market? Who’ll feel safe?
