PharmaTher Holdings, a Toronto-based psychedelics biotech firm, announced that it has successfully completed its first research study of the use of its proprietary microneedle patch for intradermal delivery of psychedelics to administer LSD. The results support the company’s investigational new drug application to the Food and Drug Administration to conduct Phase 2 clinical studies with LSD in 2022 for various indications.
In a news release announcing the completion of the study, PharmaTher said it designed the research program to develop a suitable prototype of the patch, known as MicroDose-MN, “for transdermal drug delivery to confirm compatibility and suitability to deliver LSD.”
The incorporation of LSD into the patch’s microneedles and the demonstrated ability of the patch to release the LSD over several days show the potential for larger doses and modified release profiles, PharmaTher said. The company believes its patch for delivering LSD and other psychedelics “may enable flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles.” It may also open the door for patients to dose their medication remotely without the supervision of a healthcare provider at a certified medical office or hospital.
The company currently is completing similar evaluations of the MicroDose-MN patch with MDMA and DMT, and expects to have results by the end of the year, after which it will pursue additional clinical studies in 2022.
