The introduction of the "Right to Try Clarification Act" in the United States Senate would allow end-of-life patients to attempt treatment with Schedule I drugs
VANCOUVER, BC, July 25, 2022 /CNW/ - PharmAla Biotech (CSE:MDMA) strongly applauds Senators Booker and Paul in their introduction of legislation clearly including Schedule I molecules, like MDMA, under the Right-to-Try act. The "Right-to-Try Act, 2017" allows for terminally ill patients to attempt treatment with unapproved drugs, where those drugs have been proven to have significant efficacy in early clinical research.
"As the only manufacturer of clinical-grade MDMA in North America, we are laser-focused on the development of treatments grounded in scientific evidence," said Jodi Butts, Board Chair of PharmAla Biotech. "But while more work must be done, there is already clear evidence that MDMA is a useful molecule in the treatment of fear disorders, most notably PTSD. We believe that the body of evidence – including the designation of MDMA as a "Breakthrough Therapy" by the US FDA – supports its use under 'Right-to-Try'."
PharmAla Biotech's MDMA value chain, developed entirely in Canada, is prepared and able to provide clinical grade LaNeo MDMA to patients under right-to-try immediately upon passage of the "Right-to-Try Clarification Act". PharmAla also strongly applauds U.S. Representatives Earl Blumenauer and Nancy Mace, who are expected to introduce a companion bill to the "Right-to-Try Clarification Act" in the House.
"In Canada, since January, patients have been able to request access to controlled substances through the Special Access Program. We believed this measure was timely – and that the "Right-to-Try Clarification Act will allow for the same opportunities for US residents." said Nick Kadysh, PharmAla's CEO. "Where end-of-life patients request access to therapies which may make their lives better, we have a moral obligation to attempt to help them. PharmAla stands with Sen.s Booker, Paul, and Reps. Blumenauer and Mace, and urges the US House and Senate to vote in favour of this bill with all due haste."
The "Right-to-Try Clarification Act" comes on the heels of 2 other proposals introduced by Rep. Alexandria Ocasio Cortez, and Rep. Dan Crenshaw, to allow use of MDMA and Psilocybin as an alternative to Opioids and authorizing a federal Grant program through the Pentagon to fund Psychedelics research. These measures were approved by the House of Representatives last Thursday.
PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.
Nicholas Kadysh, CEO