The Drug Enforcement Administration (“DEA”) dashed hopes for federally-relaxed marijuana laws in August. Despite mounting scientific evidence, the drug czar decided to keep marijuana as a Schedule I Controlled Substance that has ‘no currently accepted medical value’. The irony is that the FDA had already approved a cannabinoid – dronabinol – back in 1985, while GW Pharmaceuticals’ (NASDAQ: GWPH) Epidiolex has shown tremendous promise for seizures.
The decision is certainly a setback for the cannabis movement, but there are several companies that could benefit from the classification. Pharmaceutical companies that leverage cannabinoids benefit from mounting clinical evidence of safety and efficacy. Once approved, these companies can charge premium prices for their cannabinoid-based therapeutics without having to worry about competition from widely available medical marijuana.
In this article, we will take a look at Michael James Enterprises Inc. (OTC: MJTV) and its plans to reformulate and enhance the delivery of dronabinol to target sleep disorders.
Cannabinoids for Sleep Disorders
Michael James Enterprises acquired the rights and intellectual property to develop and market therapeutics for sleep disorders using the cannabinoid dronabinol as the base ingredient in early August. After its FDA approval back in 1985, Marinol® – the brand name controlled by AbbVie Inc. (NYSE: ABBV) – reach peak sales of $100 million in 2007 with dronabinol-based generics reaching $135 million in sales last year, according to IMS.
More than half of Americans report symptoms of insomnia a few nights a week or more, according to the National Sleep Foundation. A growing body of evidence suggests that tetrahydrocannabinol – or THC – may be effective in treating sleep disorders by facilitating a relaxed state of alpha-dominated waves through the adenosine pathway. The University of Illinois-Chicago’s Phase IIB clinical trials for sleep apnea should confirm these findings.
Michael James Enterprises’ proprietary formulation of dronabinol includes another active ingredient that has shown promise in pre-clinical studies. Management plans to progress its proprietary treatment through clinical trials and commercialize treatments across various sleep disorders. In the future, the company also plans to develop additional formulations of dronabinol targeting other medical indications where cannabinoids have shown promise.
Innovative Delivery Mechanism
Michael James Enterprises recently announced the purchase of a master advising agreement with HealthPartners’ William H. Frey, II, PhD., who is an expert in intranasal delivery. Dr. Frey will serve as one of the company’s scientific advisors and provide key insights to his non-invasive intranasal method for bypassing the blood-brain barrier to rapidly deliver and target therapeutic agents to the brain without unwanted side effects.
Since its dronabinol-based therapeutic acts on adenosine pathways in the brain, an intranasal delivery method could significantly improve the efficacy of the drug and set it apart from others in the space. The same delivery mechanism could be used for future dronabinol-based therapeutics that target other brain-related conditions. The company maintains the rights to all documentation and work product from its relationship with Dr. Frey under the agreement.
CEO James Farinella indicated that the company will continue to bring in top medical and scientific minds in order to ensure the ‘highest likelihood of success’ for the company and its shareholders. The company’s press release hinted that these new additions could be announced over the coming weeks and months. As the company gears up for clinical trials, these relationships could help set its sleep therapeutic apart and drive long-term success.
The DEA’s decision to keep marijuana as a Schedule I Controlled Substance may be bad news for cannabis advocates, but it’s not necessarily bad news for pharmaceutical companies involved in the space. Working with the FDA-approved cannabinoid dronabinol, Michael James Enterprises is embarking on a low-risk strategy develop and market a sleep therapeutic with a novel active ingredient, and potentially, a novel intranasal delivery system.
About Ryan Allway
Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist.