MMJ Submits FDA Investigational New Drug Application for Cannabis-Derived Drug
WASHINGTON, DC / ACCESSWIRE / December 10, 2024 / MMJ International Holdings has taken a significant step forward by submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its novel cannabis-derived medication. This significant move anticipates FDA approval to initiate comprehensive clinical trials, focusing on the treatment of chorea associated with Huntington’s disease (HD). This step is a testament to MMJ’s dedication to harnessing the therapeutic benefits of cannabis in advancing medical science.
In addition to this application, MMJ has secured an Orphan Drug designation, which highlights its commitment to addressing the critical needs of Huntington’s disease patients. This designation facilitates a faster clinical trial process, focusing on validating the efficacy of their investigational drug.
Despite facing regulatory challenges, MMJ remains steadfast in its mission to develop impactful cannabinoid-derived medicines. The upcoming Phase 2 clinical trial for MMJ-002 aims to showcase its potential to significantly mitigate the debilitating effects of Huntington’s chorea, with the goal of enhancing clinical outcomes and improving patient quality of life.
MMJ’s commitment extends beyond U.S. borders, as it navigates through DEA-imposed barriers to marijuana drug development. The company has strategically expanded its drug development operations internationally, circumventing domestic regulatory hurdles. This international approach is due to ongoing legal disputes involving the Department of Justice (DOJ) and the DEA, which are accused of contravening the presidential marijuana research act.
With a robust approach to drug discovery and development, supported by a strong intellectual property portfolio and manufacturing expertise, MMJ International Holdings continues to spearhead innovations in the medical cannabis landscape, pushing the boundaries of what is possible in cannabinoid medicine.
MMJ is represented by Attorney Megan Sheehan of Rhode Island.
CONTACT:
Madison Hisey
mhisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
View the original press release on accesswire.com
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