Pharmala Biotech Holdings Inc. (CSE:MDMA), a company focused on research, development and manufacturing of MDMA and similar class molecules, has registered a trademark for its clinical-grade, Good Manufacturing Practice MDMA product, to be available as “Laneo MDMA.”
The decision makes Pharmala the only publicly traded company to have developed a full manufacturing value series for MDMA to date, encompassing GMP manufacturing of Active Pharmaceutical Ingredients (API) and drug product formulation.
The company defines itself as a "regulatory first" organization, which translates to the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators.
Pharmala’s two main goals are to provide appropriate MDMA for clinical trials and to develop novel drugs in the same class. In this sense, along with the current trademark for MDMA, the company has begun preclinical research into two patented Novel Chemical Entities based on MDMA class molecules both in the U.S. and in Canada.
About the most recent resolution, the Director of Sales at Pharmala Biotech, David Purcell, commented: "We're speaking to customers every day who are excited to initiate clinical trials with MDMA –but they are unable to do so because up until now, they didn't have access to clinical trial supply of drug product."
Well, Laneo MDMA seems to be a possible answer. At the moment, the compound can be purchased in two different formats: a 40mg clinical trial capsule or the pure active pharmaceutical ingredient to be compounded by a qualified pharmacist.
According to the company, it has already received deposits from interested parties. The initial product deliveries are set for the fall of 2022.
