Our Co-Founder & CEO Florian Brand wrote to administrator Anne Milgram and the Drug Enforcement Administration (DEA) to encourage the agency to withdraw its proposed rule around placing two psychedelics – 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) – into schedule I.
We believe that increased access to psychedelic substances for clinical trials is crucial for the timely development of novel mental health treatments. Strict scheduling increases barriers to research and can disrupt patient access to new medicines.
While we are eager to work with the DEA and others to ensure that substances with significant abuse liability are properly regulated, there is not enough data to justify the obstacles to research that this proposed rule would impose. The DEA withdrew an identical version of this proposal in 2022, so we are hopeful they will be receptive to public feedback once more.
Thank you to everyone else that submitted comments and we trust that the DEA will continue to be a productive partner in the search for new medicines for the millions of Americans who need them.
SUBMITTED ELECTRONICALLY VIA
https://www.regula ons.gov/
Administrator Anne Milgram
Drug Enforcement Agency
U.S. Department of Justice
Attention: Docket No. DEA-1156
8701 Morrissette Drive
Springfield, VA 22152
Re: Schedules of Controlled Substances: Placement of 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) in Schedule I
Dear Administrator Milgram:
On behalf of atai Life Sciences, I am pleased to submit these comments on the Drug Enforcement Agency’s (DEA) proposed rule on the Schedules of Controlled Substances: Placement of 2,5-dimethoxy-4- iodoamphetamine (DOI) and 2,5-dimethoxy-4-chloroamphetamine (DOC) in Schedule I (DEA-1156) (hereina^er, “Proposed Rule”).
atai is a clinical-stage biopharmaceutical company currently developing multiple drug compounds – both psychedelic and non-psychedelic – for the treatment of various mental health disorders. Specifically, we are currently in Phase 1 clinical trials of N,N-dimethyltryptamine (DMT), and R-3,4-Methylenedioxy methamphetamine (R-MDMA) for treatment-resistant depression (TRD) and post-traumaHc stress disorder (PTSD) respectively. Additionally, we’ve added strategic investments in late-stage programs around psilocybin and 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT).
Increased access to psychedelic substances for clinical trials is crucial for the timely development of additional mental health treatments. Strict scheduling increases barriers to research and disrupts patient access to new medicines. For example, contract development and manufacturing organizations (CDMOs) can charge up to 30% more for scheduled substances. Even if the drug is eventually approved, these costs can affect its availability due to impacts on payer reimbursement.
In 2022, we were highly encouraged by the DEA’s willingness to accede to public comments advising the withdrawal of an identical version of the currently proposed rule. Similarly, we applauded the DEA for changing course on its proposed rule for the Placement of 4-hydroxy-N,N-diisopropyltryptamine, 5- methoxy-alpha-methyltryptamine, 5-methoxy-N-methyl-N-isopropyltryptamine, 5-methoxy-N,N- diethyltryptamine, and N,N-diisopropyltryptamine in Schedule I.
Atai Life Sciences views the reintroduction of this proposed rule as a step back in the DEA’s process for evaluating the medical value of novel therapies. We recommend that the agency withdraw the proposed rule once again.
The DEA states that the scientific and medical basis for scheduling DOI and DOC remains the same as it was in 2022. Yet, the DEA’s own proposal acknowledges1,2 “there have been no reports of distressing responses or death associated with DOI in medical literature” and “the physiological dependence liability of DOI and DOC in animals and humans is not reported in scientific and medical literature”. While the agency does note three published accounts of adverse events – including one death – in individuals who had used DOC, in each of those instances, the users had taken other drugs concomitantly.
With incredibly low remission rates among people with common mental health disorders – up to a third of depression patients are considered treatment resistant3, and up to 75% of those treated for opioid use disorder will relapse4 – and almost half of the US population is expected to develop a mental health condition at some point in their lives5, research into new options for patients must be encouraged rather than restricted.
In sum, Atai and others are eager to partner with the DEA to help ensure that (1) substances with significant abuse potential are regulated appropriately and (2) that those with potential medical benefits are available to researchers without unnecessary hurdles. We thank you for the opportunity to comment on the proposed placement of DOI and DOC in Schedule I and trust the DEA will continue to be a receptive partner in the search for much-needed options for underserved patients.
Sincerely,
Florian Brand
Co-Founder and CEO atai Life Sciences
______________________________
1 Schedules of Controlled Substances: Placement of 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4- chloroamphetamine (DOC) in Schedule I (https://www.federalregister.gov/documents/2023/12/13/2023-27289/schedules-of-controlled-substances-placement-of-25-dimethoxy-4-iodoamphetamine-doi-and#p-65)
2 Schedules of Controlled Substances: Placement of 2,5-dimethoxy-4-iodoamphetamine (DOI) and 2,5-dimethoxy-4- chloroamphetamine (DOC) in Schedule I (https://www.federalregister.gov/documents/2023/12/13/2023-27289/schedules-of-controlled-substances-placement-of-25-dimethoxy-4-iodoamphetamine-doi-and#p-66)
3 Salzer, “NaRonal EsRmates of Recovery-Remission From Serious Mental Illness”, Psychiatry Online (2018)
4 Sinha R. New findings on biological factors predicting addiction relapse vulnerability. Curr Psychiatry Rep. 2011 Oct;13(5):398-405. doi: 10.1007/s11920-011-0224-0. PMID: 21792580; PMCID: PMC3674771.
5 Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. LifeRme prevalence and age-of-onset distributions of DSM-IV disorders in the NaRonal Comorbidity Survey ReplicaRon. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593. Erratum in: Arch Gen Psychiatry. 2005 Jul;62(7):768. Merikangas, Kathleen R [added]. PMID: 15939837.
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