- PharmAla Biotech (MDMA) and Shaman Pharma granted first ever special access program authorization for MDMA
- The drug will be used to treat patients under Health Canada’s Special Access Program
- The drug and its distribution will be delivered on a compassionate-use basis
- PharmAla is the first publicly traded company to manufacture GMP MDMA, and is the first company to make available to researchers two clinical-grade Psychedelic APIs
- PharmAla Biotech (MDMA) is up 6.90 percent, trading at C$0.47 at 1:21 pm EST
PharmAla Biotech Holdings (MDMA) receives approval for a number of is LaNeo MDMA capsules to a Canadian physician.
The drug will be used to treat patients under Health Canada’s Special Access Program.
The company is also celebrating that this is the first time authorization has been granted to an MDMA-assisted therapy treatment under the Special Access Program.
“It’s absolutely thrilling to be able to say that our GMP LaNeo MDMA will be used for the treatment of a patient in Canada,” said Nick Kadysh, CEO of PharmAla.
“This regulatory milestone isn’t about financial impact, but healthcare impact,” added Kadysh.
What the MDMA approval will do
Regarding the drug and its distribution, the plan is to deliver it on a compassionate-use basis. As for the future, the plan is to charge patients on a cost-recovery basis.
With the ever evolving discussion and public acceptance of the drug. CEO Shaman Pharma, Alexandre Grener, is thrilled about changing the narrative of MDMA.
“Let’s be clear: this is not a product promotion. It’s a testament to our unwavering dedication to scientific discovery and advancement in patient care.”
“As we take part in this landmark moment alongside PharmAla Biotech, our commitment is not just to follow progress, but actively lead it,” added Grener.
PharmAla is the first publicly traded company to manufacture GMP MDMA, and is the first company to make available to researchers two clinical-grade Psychedelic APIs.
The company also hosted a webinar around its new joint venture in Australia, Cortexa. The meeting took place on May 16 at 7 am EST.
PharmAla, a biotechnology company, is the first publicly traded company to manufacture GMP MDMA.
PharmAla Biotech (MDMA) is up 6.90 percent, trading at C$0.47 at 1:21 pm EST