Optimi Health Completes Largest-to-Date MDMA Export to Australia for PTSD Therapy
Optimi Health (OPTHF) has completed its largest international MDMA export to Australia, delivering 1,000 GMP-certified capsules for PTSD treatment. The shipment, conducted with Mind Medicine Australia, includes both 40mg and 60mg strength capsules and received approval from Australia's Therapeutic Goods Administration (TGA) and Health Canada.
In a significant development, the Australian Department of Veterans' Affairs (DVA) has announced it will fund MDMA-assisted therapy for veterans diagnosed with PTSD, marking the first time a federal agency in Australia has committed to reimbursing psychedelic-assisted treatment. The capsules will be distributed through authorized pharmacy networks and clinics across Australia under Optimi's Drug Establishment Licence (DEL).
Optimi Health (OPTHF) ha completato la sua più grande esportazione internazionale di MDMA verso l'Australia, consegnando 1.000 capsule certificate GMP per il trattamento del disturbo da stress post-traumatico (PTSD). La spedizione, effettuata in collaborazione con Mind Medicine Australia, comprende capsule da 40 mg e 60 mg e ha ottenuto l'approvazione dalla Therapeutic Goods Administration (TGA) australiana e da Health Canada.
In un importante sviluppo, il Dipartimento per gli Affari dei Veterani australiano (DVA) ha annunciato che finanzierà la terapia assistita con MDMA per i veterani diagnosticati con PTSD, segnando la prima volta che un'agenzia federale australiana si impegna a rimborsare trattamenti assistiti con psichedelici. Le capsule saranno distribuite attraverso reti di farmacie autorizzate e cliniche in tutta l'Australia sotto la licenza di stabilimento farmaceutico (DEL) di Optimi.
Optimi Health (OPTHF) ha completado su mayor exportación internacional de MDMA a Australia, entregando 1,000 cápsulas certificadas GMP para el tratamiento del trastorno de estrés postraumático (TEPT). El envío, realizado en colaboración con Mind Medicine Australia, incluye cápsulas de 40 mg y 60 mg y recibió la aprobación de la Administración de Productos Terapéuticos (TGA) de Australia y de Health Canada.
En un desarrollo significativo, el Departamento de Asuntos de Veteranos de Australia (DVA) ha anunciado que financiará la terapia asistida con MDMA para veteranos diagnosticados con TEPT, marcando la primera vez que una agencia federal en Australia se compromete a reembolsar tratamientos asistidos con psicodélicos. Las cápsulas se distribuirán a través de redes de farmacias autorizadas y clínicas en toda Australia bajo la Licencia de Establecimiento de Medicamentos (DEL) de Optimi.
Optimi Health (OPTHF)는 PTSD 치료를 위한 1,000개의 GMP 인증 캡슐을 호주로 수출하는 최대 규모의 국제 MDMA 수출을 완료했습니다. 이번 배송은 Mind Medicine Australia와 협력하여 진행되었으며, 40mg과 60mg 두 가지 용량의 캡슐로 구성되어 있으며 호주의 치료용품관리국(TGA)과 캐나다 보건부의 승인을 받았습니다.
중대한 진전으로 호주 재향군인부(DVA)는 PTSD 진단을 받은 재향군인을 위한 MDMA 보조 치료를 자금 지원할 것이라고 발표했으며, 이는 호주 연방 기관이 환각제 보조 치료 비용을 처음으로 환급하기로 한 사례입니다. 캡슐은 Optimi의 의약품 시설 허가(DEL) 하에 호주 전역의 허가된 약국 네트워크와 클리닉을 통해 배포될 예정입니다.
Optimi Health (OPTHF) a réalisé sa plus grande exportation internationale de MDMA vers l'Australie, livrant 1 000 capsules certifiées GMP pour le traitement du trouble de stress post-traumatique (TSPT). L'expédition, effectuée en collaboration avec Mind Medicine Australia, comprend des capsules de 40 mg et 60 mg et a reçu l'approbation de la Therapeutic Goods Administration (TGA) australienne ainsi que de Santé Canada.
Dans une avancée majeure, le Département australien des Anciens Combattants (DVA) a annoncé qu'il financerait la thérapie assistée par la MDMA pour les anciens combattants diagnostiqués avec un TSPT, marquant la première fois qu'une agence fédérale australienne s'engage à rembourser un traitement assisté par psychédéliques. Les capsules seront distribuées via des réseaux de pharmacies autorisées et des cliniques à travers l'Australie sous la licence d'établissement pharmaceutique (DEL) d'Optimi.
Optimi Health (OPTHF) hat seine bisher größte internationale MDMA-Ausfuhr nach Australien abgeschlossen und 1.000 GMP-zertifizierte Kapseln zur Behandlung von PTBS geliefert. Die Lieferung, die in Zusammenarbeit mit Mind Medicine Australia erfolgte, umfasst Kapseln mit 40 mg und 60 mg und wurde von der Therapeutic Goods Administration (TGA) Australiens sowie Health Canada genehmigt.
In einer bedeutenden Entwicklung hat das Australische Ministerium für Veteranenangelegenheiten (DVA) angekündigt, MDMA-unterstützte Therapien für Veteranen mit PTBS zu finanzieren. Dies ist das erste Mal, dass eine Bundesbehörde in Australien die Erstattung psychedelisch unterstützter Behandlungen zusagt. Die Kapseln werden unter Optimis Arzneimittelbetriebs-Erlaubnis (DEL) über autorisierte Apothekennetzwerke und Kliniken in ganz Australien verteilt.
- Largest international MDMA export completed with 1,000 GMP-certified capsules
- First-ever Australian federal agency (DVA) commitment to fund psychedelic-assisted treatment
- Secured regulatory approvals from both TGA and Health Canada
- Established distribution network through licensed pharmacies and clinics across Australia
- None.
1,000 GMP doses of MDMA now reaching patients with PTSD under Australia's Authorised Prescriber Scheme; Department of Veterans' Affairs to fund treatment for veterans
Vancouver, British Columbia--(Newsfile Corp. - May 8, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Canadian drug manufacturer and formulator of GMP-grade MDMA and natural psilocybin, has completed its largest international export to date of MDMA capsules to Australia, supporting the treatment of Post-Traumatic Stress Disorder (PTSD) under the country's Authorised Prescriber Scheme.
The shipment, conducted in partnership with Mind Medicine Australia, included 1,000 GMP MDMA capsules in both 40mg and 60mg strengths. Import approval was granted by Australia's Therapeutic Goods Administration (TGA), with matching export permits issued from Health Canada. The capsules were manufactured and shipped under Optimi's Drug Establishment Licence (DEL), authorizing global distribution for PTSD treatment through licensed pharmacy networks and authorised clinics across Australia.
In a major step forward for access, the Australian Department of Veterans' Affairs (DVA) recently announced that it will fund MDMA-assisted therapy for veterans diagnosed with PTSD. This marks the first time a federal agency in Australia has committed to reimbursing psychedelic-assisted treatment, reinforcing national momentum toward broader mental health care solutions and highlighting the need for safe, GMP-supplied medicines.
Mind Medicine Australia welcomed the announcement as a meaningful step toward broadening access to care for those who need it most.
"The announcement from the Department of Veterans' Affairs to fund MDMA-assisted therapy is a major endorsement of this treatment approach," said Peter Hunt AM, Chair of Mind Medicine Australia. "It demonstrates growing recognition at the highest levels of government that these therapies can offer meaningful recovery for people living with PTSD."
"Our team has worked hard to reach this point, and it's incredibly meaningful to know that patients are now being treated with the MDMA capsules we've manufactured and delivered into the country," said Dane Stevens, CEO of Optimi. "The support of the Department of Veterans' Affairs is a major step forward for patient access, and we're proud to work alongside Mind Medicine Australia to ensure this treatment is delivered safely and responsibly within a regulated framework."
Key Highlights
- Shipment includes 1,000 GMP-certified MDMA capsules in 40mg and 60mg strengths
- Department of Veterans' Affairs to fund MDMA-assisted therapy for Australian veterans with PTSD
- Import approval granted by Australia's TGA, with matching export permits from Health Canada
- Export conducted under Optimi's Drug Establishment Licence, authorizing prescription for the defined therapeutic indication of PTSD
- Capsules to be dispensed through authorised pharmacy networks and clinics nationwide
Ordering From Optimi
Entities interested in accessing Optimi's GMP 40mg and 60mg MDMA capsules can contact:
Australia: Mind Medicine Australia
Global Inquiries: sales@optimihealth.ca
About Optimi Health Corp.
Optimi Health Corp. is a Health Canada-licensed, GMP-compliant manufacturer and supplier of natural psilocybin and MDMA. Dedicated to producing high-quality psychedelic products, the Company aims to support the global advancement of mental health therapies through rigorous compliance, innovation, and collaboration.
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On Behalf of the Board
JJ Wilson, Chair of the Board
For more information, please contact:
Optimi Health Corp.
Telephone: (778) 761-4551
investors@optimihealth.ca
www.optimihealth.ca
Forward-Looking Statements
This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, "forward-looking statements"). Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties, and contingencies, certain of which are unknown. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions, or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward-looking statements. These statements may involve estimates, assumptions, and uncertainties that could cause actual results or outcomes to differ materially from those expressed in such forward-looking statements. No assurance can be given that these expectations will prove to be correct, and such forward-looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release.
Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Such risk factors include but are not limited to those factors which are discussed in the Company's long form prospectus dated February 12, 2021, a copy of which is available on SEDAR+ at www.sedarplus.ca. Except as expressly required by applicable law, Optimi undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Any forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
Neither the Canadian Securities Exchange nor the Canadian Investment Regulatory Organization accepts responsibility for the adequacy or accuracy of this release.
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FAQ
What is the size of Optimi Health's (OPTHF) MDMA export to Australia in 2025?
How will the Australian Department of Veterans' Affairs support MDMA therapy for PTSD?
What regulatory approvals did Optimi Health receive for its MDMA export to Australia?
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