From Plant to Pill: MMJ-001 Marks a Pharmaceutical First in Cannabis Medicine with FDA-Grade Formulation for a Devastating Neurological Disorder while awaiting final FDA approval for use in clinical trials.
WASHINGTON, D.C. / ACCESS Newswire / July 8, 2025 / Inside a pharmaceutical facility at an undisclosed location, Dr. Elio Mariani, an accomplished pharmaceutical chemist with decades of experience in FDA approved drug formulation, carefully examines a freshly produced batch of MMJ International's soft gelatin capsules. These capsules, each containing a precisely balanced combination of natural THC and CBD extracted from proprietary cannabis strains, represent a historic first: a pharmaceutical grade, plant derived cannabis drug called MMJ-001, developed specifically for chorea associated with Huntington's Disease (HD)-a devastating neurological disorder that affects tens of thousands of Americans.
PHOTO: Duane Boise (right) with Dr. Elio Mariani, lead chemist at MMJ's pharmaceutical cannabis facility. MMJ-001 is the only known natural THC/CBD softgel currently in the FDA pipeline with Orphan Drug status for Huntington's Disease.
Leading the charge is Duane Boise, CEO of MMJ International Holdings, a pioneering biopharmaceutical company that is taking a strictly pharmaceutical approach to cannabis drug development. MMJ-001 is not a dietary supplement. It is not sold in dispensaries. It is not synthetic. It is a carefully manufactured investigational new drug (IND) composed of natural cannabis extracts and formulated in pharmaceutical-grade capsules under FDA standards.
"We're not interested in chasing the wellness trends or the recreational market," says Boise. "This is about providing real medicine to real patients-starting with one of the most vulnerable populations: those suffering from Huntington's Disease."
Orphan Drug Designation: A Path Forward
What gives MMJ-001 a unique advantage in the competitive and costly drug approval process is its Orphan Drug Designation from the U.S. Food and Drug Administration. This rare status is granted to treatments targeting conditions that affect fewer than 200,000 Americans and comes with a host of benefits: seven years of market exclusivity, tax credits, waived FDA fees, and access to accelerated review pathways.
"Orphan status is not just a regulatory milestone-it's a lifeline," explains Boise. "It shows the FDA recognizes the urgent unmet medical need and our serious commitment to bringing a therapeutic option to these patients."
Natural vs. Synthetic: A Crucial Distinction
Unlike synthetic single-molecule THC products like Marinol (dronabinol) or nabiximols (which failed its Phase III trial in the U.S.), MMJ-001 preserves the full therapeutic potential of the cannabis plant. The drug is manufactured using natural full-spectrum extracts from MMJ's proprietary cultivars, grown specifically for pharmaceutical use. Each softgel is standardized to ensure consistent dosing and bioavailability.
"You cannot recreate the complexity of the cannabis plant in a lab," says Dr. Mariani. "We're not chasing isolated molecules-we're working with the entourage effect of nature's own design, under GMP conditions."
Clinical Development with FDA
MMJ-001 is currently progressing toward Phase II FDA-sanctioned human trials after successful preclinical investigations and collaborative input from top neurologists at a leading U.S. research university specializing in Huntington's Disease. The company has worked closely with the FDA throughout its development, submitting its Investigational New Drug (IND) application and receiving validation for its pharmaceutical-grade approach.
Dr. Mariani, who oversees a team of chemists at a secure facility licensed by the DEA and registered with the FDA, emphasizes the complexity of the formulation process:
"This isn't just about blending oils," he says. "We're developing a pharmaceutical product-meeting rigorous standards for stability, purity, and reproducibility. Our work is governed by science, not hype."
The Billion-Dollar Potential of Pharmaceutical Cannabis
MMJ International Holdings joins a small but elite group of companies pursuing true pharmaceutical cannabis-a field with few successes but massive upside. GW Pharmaceuticals broke ground with Epidiolex, a plant-derived CBD formulation approved by the FDA for seizure disorders, reaching nearly $1 billion in annual sales before being acquired by Jazz Pharmaceuticals for $7.2 billion.
Boise sees MMJ-001 on a similar trajectory:
"With an addressable patient population in the tens of thousands, no existing cannabis-based therapy approved for chorea in Huntington's, and a patent-pending formulation, MMJ-001 is poised to fill a critical gap in neurodegenerative care," he says.
A Controlled Path in a Chaotic Market
Unlike the supplement space where Charlotte's Web and others flourished temporarily before facing market saturation and regulatory tightening, MMJ's strategy has been from day one FDA compliance, not commercial fads.
"We're not trying to be the next dispensary brand," says Boise. "We are here to meet the FDA's gold standard for drug development-and bring real relief to patients who have been ignored by Big Pharma for far too long."
What's Next
With Phase II trials on the horizon and international partners already secured for future production and distribution, MMJ-001 represents more than a drug candidate. It's a signal that botanical cannabis-based pharmaceuticals are not only viable-they're essential.
As Boise puts it:
"It's not about whether this can be done. It's about whether we're willing to do the hard work to make it happen. At MMJ, we already are."
MMJ is represented by attorney Megan Sheehan.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/mmj-international-redefines-medical-cannabis-with-first-plant-based-d-1045218
