PharmAla Biotech Holdings Inc. (CSE: MDMA; OTC: MDXXF), a biotechnology company specializing in MDMA research, development, and manufacturing, has entered into an agreement with Merhavim Mental Health Centre in Beer Yaakov, Israel, to supply clinical trial material for a study on the use of MDMA in treating PTSD. The trial, titled “MDMA Assisted Psychotherapy for PTSD of Early Sexual Trauma Compared to All Trauma in Adulthood,” will examine the efficacy of MDMA-assisted psychotherapy for individuals suffering from PTSD caused by early sexual trauma, compared to PTSD from trauma experienced in adulthood.
Key Details of the Partnership
Under the terms of the agreement, PharmAla will provide the LaNeo™ MDMA clinical research material for the trial at no cost. In return, all data generated during the clinical trial will be licensed to PharmAla for regulatory and commercial purposes. This partnership will enable PharmAla to expand its body of clinical evidence supporting MDMA’s efficacy in treating PTSD.
MAPS Israel, an Israeli non-profit organization focused on advancing psychedelic research and education, is also a key partner in the clinical trial. The partnership aims to contribute to the growing body of research on MDMA as a treatment for PTSD, especially in the context of trauma caused by early sexual abuse.
The Role of MDMA in PTSD Treatment
MDMA, commonly known for its use in recreational contexts, is being explored for its therapeutic potential in the treatment of PTSD. A body of clinical data already supports its efficacy in treating trauma, and PharmAla is working to expand that data through partnerships like this one. The Merhavim trial is particularly notable because it will be the first to explicitly focus on comparing the effectiveness of MDMA in treating PTSD related to early sexual trauma versus trauma experienced in adulthood.
“The recent announcement of a cease-fire in the Gaza conflict means that now is the time to work towards healing,” said Nicholas Kadysh, CEO of PharmAla. “We look forward to supporting Merhavim in their clinical trial, which we believe will help patients in Israel, and ultimately worldwide.”
Regulatory Process and Future Collaborations
PharmAla plans to ship its LaNeo MDMA Clinical Research Materials to Merhavim as soon as regulatory approvals are obtained. The company is also optimistic about future collaborations with MAPS Israel, as they continue to work together on expanding psychedelic research and addressing mental health challenges globally.
Researchers interested in PharmAla’s drug products can access detailed information about the company’s clinical trials and drug quality at the PharmAla website, where they can also receive support for converting clinical trial registrations and IRB approvals to the LaNeo MDMA Chemistry, Manufacturing, and Control package.
This agreement underscores PharmAla’s commitment to advancing research on the therapeutic uses of MDMA and expanding its role in the evolving field of psychedelic medicine.
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