Optimi Health Completes Second MDMA Shipment to Australia and Expands 2025 Production Forecast to Support Over 5,000 Patients Globally
Optimi Health (OPTHF) has completed its second shipment of GMP-certified MDMA capsules to Australia and increased its 2025 production forecast to support over 5,000 patients globally. The company, which manufactures psychedelic pharmaceuticals under Health Canada license, is working in partnership with Mind Medicine Australia to distribute the products through a regulated pharmacy network.
The initiative includes collecting patient-reported outcomes via the Australian National University's registry, creating one of the largest Real World Evidence datasets on MDMA-assisted therapy. The company's expanded production capacity aims to ensure consistent access to high-quality GMP-certified products for healthcare providers in Australia while supporting ongoing and future clinical trials.
The partnership with Mind Medicine Australia focuses on making these therapies accessible at optimal pricing, promoting equitable access. This development is significant given that PTSD affects 6% of U.S. adults during their lifetime, with an estimated economic burden of $232 billion annually in the U.S. alone.
Optimi Health (OPTHF) ha completato la sua seconda spedizione di capsule di MDMA certificate GMP in Australia e ha aumentato la sua previsione di produzione per il 2025 per supportare oltre 5.000 pazienti a livello globale. L'azienda, che produce farmaci psichedelici con licenza da Health Canada, sta collaborando con Mind Medicine Australia per distribuire i prodotti attraverso una rete di farmacisti regolamentata.
L'iniziativa include la raccolta degli esiti riportati dai pazienti attraverso il registro della National University australiana, creando uno dei più grandi dataset di Evidenza del Mondo Reale sulla terapia assistita da MDMA. La capacità produttiva ampliata dell'azienda mira a garantire un accesso costante a prodotti di alta qualità certificati GMP per i fornitori di assistenza sanitaria in Australia, mentre sostiene prove cliniche in corso e future.
La partnership con Mind Medicine Australia si concentra sull'accessibilità di queste terapie a prezzi ottimali, promuovendo l'accesso equo. Questo sviluppo è significativo dato che il PTSD colpisce il 6% degli adulti negli Stati Uniti nel corso della loro vita, con un onere economico stimato di 232 miliardi di dollari all'anno solo negli Stati Uniti.
Optimi Health (OPTHF) ha completado su segundo envío de cápsulas de MDMA certificadas por GMP a Australia y ha aumentado su pronóstico de producción para 2025 para apoyar a más de 5,000 pacientes a nivel mundial. La empresa, que fabrica productos farmacéuticos psicodélicos bajo licencia de Health Canada, está trabajando en colaboración con Mind Medicine Australia para distribuir los productos a través de una red de farmacias regulada.
La iniciativa incluye la recopilación de resultados reportados por pacientes a través del registro de la Universidad Nacional de Australia, creando uno de los conjuntos de datos de Evidencia del Mundo Real más grandes sobre terapia asistida con MDMA. La capacidad de producción ampliada de la empresa tiene como objetivo garantizar un acceso constante a productos de alta calidad certificados por GMP para los proveedores de salud en Australia, al mismo tiempo que apoya ensayos clínicos en curso y futuros.
La asociación con Mind Medicine Australia se centra en hacer que estas terapias sean accesibles a precios óptimos, promoviendo el acceso equitativo. Este desarrollo es significativo dado que el PTSD afecta al 6% de los adultos en EE. UU. a lo largo de su vida, con una carga económica estimada de 232 mil millones de dólares anuales solo en EE. UU.
Optimi Health (OPTHF)는 호주에 GMP 인증 MDMA 캡슐 두 번째 배송을 완료하고, 2025년 생산 전망을 증가시켜 전 세계 5,000명 이상의 환자를 지원한다고 발표했습니다. 캐나다 보건부의 라이선스 하에 환각제 의약품을 제조하는 이 회사는 마인드 메디슨 오스트레일리아와 협력하여 규제된 약국 네트워크를 통해 제품을 배포하고 있습니다.
이 이니셔티브에는 호주 국립대학교의 등록부를 통해 환자 보고 결과를 수집하는 것이 포함되어 있으며, MDMA 지원 치료에 대한 가장 큰 실증적 데이터 세트를 생성하고 있습니다. 회사의 생산 능력 확대는 호주의 의료 제공자를 위해 GMP 인증된 고품질 제품에 대한 지속적인 접근을 보장하고 진행 중인 그리고 미래의 임상 시험을 지원하기 위한 것입니다.
마인드 메디슨 오스트레일리아와의 파트너십은 이러한 치료법을 최적의 가격에 접근할 수 있도록 하여 공정한 접근을 촉진하는 데 중점을 두고 있습니다. PTSD는 미국 성인의 6%가 평생 동안 영향을 받는다는 점에서, 이 발전은 중요하며 미국에서만 연간 2,320억 달러의 경제적 부담이 추정됩니다.
Optimi Health (OPTHF) a complété sa deuxième expédition de capsules de MDMA certifiées GMP vers l'Australie et a augmenté ses prévisions de production pour 2025 afin de soutenir plus de 5 000 patients dans le monde. L’entreprise, qui fabrique des produits pharmaceutiques psychédéliques sous licence de Santé Canada, travaille en partenariat avec Mind Medicine Australia pour distribuer les produits via un réseau de pharmacies réglementées.
L'initiative comprend la collecte des résultats rapportés par les patients via le registre de l'Université Nationale australienne, créant ainsi l'un des plus grands ensembles de données sur les preuves du monde réel en matière de thérapie assistée par MDMA. La capacité de production accrue de l'entreprise vise à garantir un accès constant à des produits de haute qualité certifiés GMP pour les prestataires de soins de santé en Australie, tout en soutenant les essais cliniques en cours et futurs.
Le partenariat avec Mind Medicine Australia se concentre sur l'accessibilité de ces thérapies à des prix optimaux, promouvant ainsi un accès équitable. Ce développement est significatif étant donné que le PTSD touche 6 % des adultes américains au cours de leur vie, avec un fardeau économique estimé à 232 milliards de dollars par an rien qu'aux États-Unis.
Optimi Health (OPTHF) hat seine zweite Lieferung von GMP-zertifizierten MDMA-Kapseln nach Australien abgeschlossen und seine Produktionsprognose für 2025 erhöht, um über 5.000 Patienten weltweit zu unterstützen. Das Unternehmen, das psychedelische Arzneimittel unter der Lizenz von Health Canada herstellt, arbeitet in Partnerschaft mit Mind Medicine Australia, um die Produkte über ein reguliertes Apothekernetzwerk zu vertreiben.
Die Initiative umfasst die Sammlung von Patientenberichten über das Register der Australischen Nationaluniversität und schafft einen der größten Datensätze zur Evidenz aus der realen Welt in Bezug auf MDMA-unterstützte Therapie. Die erweiterte Produktionskapazität des Unternehmens zielt darauf ab, den konsequenten Zugang zu hochwertigen GMP-zertifizierten Produkten für Gesundheitsdienstleister in Australien zu gewährleisten und gleichzeitig laufende und zukünftige klinische Studien zu unterstützen.
Die Partnerschaft mit Mind Medicine Australia konzentriert sich darauf, diese Therapien zu optimalen Preisen zugänglich zu machen und einen gerechten Zugang zu fördern. Diese Entwicklung ist bedeutend, da PTSD 6 % der US-Erwachsenen in ihrem Leben betrifft, mit einer geschätzten wirtschaftlichen Belastung von jährlich 232 Milliarden US-Dollar nur in den USA.
- Successful completion of second GMP-certified MDMA shipment to Australia
- Increased production forecast for 2025 to support over 5,000 patients globally
- Established partnership with Mind Medicine Australia for regulated distribution
- Development of comprehensive Real World Evidence dataset through Australian National University
- None.
Vancouver, British Columbia--(Newsfile Corp. - January 6, 2025) - Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FSE: 8BN) ("Optimi" or the "Company"), a Health Canada-licensed manufacturer of psychedelic pharmaceuticals specializing in natural psilocybin and MDMA, is pleased to announce the completion of its second shipment of GMP-certified MDMA capsules to Australia.
Optimi has also increased its 2025 production forecast to supply enough MDMA capsules for over 5,000 patients globally. This expanded capacity highlights the Company's commitment to ensuring healthcare providers in Australia have consistent access to high-quality GMP-certified products while also supporting ongoing and future clinical trials.
Key Highlights
- Second Export Complete: The second shipment of GMP-certified MDMA capsules has arrived in Australia and will support PTSD treatments throughout 2025.
- Increasing Demand: Optimi's production forecast has been increased to supply enough MDMA capsules for over 5,000 patients globally.
- On-Site Manufacturing: Optimi's MDMA capsules are produced at its purpose-built facilities under the Company's Drug Establishment Licence and are distributed through a regulated pharmacy network in partnership with Mind Medicine Australia.
- Data Collection Advancements: Patient-reported outcomes (PROs) are being gathered via the Australian National University's registry, creating one of the largest Real World Evidence (RWE) datasets on MDMA-assisted therapy to date.
Dane Stevens, CEO of Optimi Health
"With the completion of our second shipment of GMP-certified MDMA capsules to Australia, we're making meaningful progress in delivering high-quality therapeutic options to patients today," said Dane Stevens, CEO of Optimi Health. "This milestone, supported by approvals from both Health Canada and the Therapeutic Goods Administration, underscores the trust in our GMP manufacturing processes and the growing demand for these transformative therapies.
"Following recent purchase orders, the Company has updated its 2025 production forecast to supply enough MDMA capsules for over 5,000 patients globally, ensuring our customers and patients alike have consistent and reliable access to MDMA-assisted therapy," Stevens added.
Partnership with Mind Medicine Australia
"This milestone highlights the growing confidence in MDMA-assisted therapy as an effective treatment for PTSD," said Peter Hunt, Chairman of Mind Medicine Australia. "Through our partnership with Optimi Health, we are ensuring that practitioners have the tools, resources, and tailored training needed to safely deliver these therapies while also collecting vital real-world data to guide global mental health strategies.
"This partnership furthers our charitable mission by making medicines available to patients at the best possible price, promoting equitable access for all. By prioritizing affordability and quality, we are setting a strong foundation for the future of mental health treatment."
Global Context
PTSD affects millions worldwide, including
Access for Authorised Prescribers in Australia
Healthcare professionals and Authorised Prescribers seeking access to Optimi's GMP MDMA and psilocybin products can contact Mind Medicine Australia via their website.
About Optimi Health Corp.
Optimi Health Corp. is a Health Canada-licensed, GMP-compliant manufacturer and supplier of natural psilocybin and MDMA. The Company focuses on scalable production and distribution to regulated markets, including the development of innovative psychedelic products to support the mental health and wellness of patients worldwide. Optimi is dedicated to advancing psychedelic therapies with a commitment to quality, compliance, and accessibility.
On behalf of the Board of Directors,
OPTIMI HEALTH CORP.
JJ Wilson, Chair of the Board
For more information, please contact the Company at:
Telephone: (778) 761-4551
Email: investors@optimihealth.ca
Website: 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") that relate to Optimi's current expectations and views of future events. 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. 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.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/236124
FAQ
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