Author Topic: Monopoly on FDA-approved Cannabis May Hold Back Parkinson's Drug Development  (Read 388 times)

Offline Chip (OP)

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source: https://www.analyticalcannabis.com/news/monopoly-on-fda-approved-cannabis-may-hold-back-parkinsons-drug-development-299818?__hstc=8807082.2a85ec03b0fe551e93651f4423940966.1525210082306.1525210082306.1525213907776.2&__hssc=8807082.1.1525213907776&__hsfp=1296595349



GB Sciences, as previously reported, plans to file an Exploratory IND and perform a Phase 0 Clinical Trial to gather valuable First-In-Human data, to support clinical development decisions on prioritizing among multiple, related Parkinson's Disease (PD) formulations.  GB Sciences has a patent application covering multiple, related PD-formulas that are based on complex mixtures of minor cannabinoids and terpenes from cannabis chemovars. In preclinical studies, GB Sciences has demonstrated that complex mixtures of cannabis-based compounds may provide greater clinical benefits than single compound treatments due to molecular synergies for the treatment of Parkinson's.



Sourcing sufficient quantities of these minor cannabinoids and terpenes is essential for providing the highest possible efficacy in GB Sciences' PD formulations, but they are more difficult to procure in botanical form because they are in lower abundance in the cannabis plants. GB Sciences has been addressing these supply issues at its cultivation and extraction facility in Las Vegas, Nevada; however, currently there is only a sole source for domestic cannabis used in FDA research.



"The challenge we have encountered in approaching the US FDA is that we may not be able to use cannabis-based materials that GB Sciences has developed in the US for our clinical trials," explains Dr. Andrea Small-Howard, Chief Science Officer of GB Sciences. "We are committed to complying with all federal requirements, even though we believe we can implement a system for growing and extracting here that exceeds the quality and consistency of the materials that we could obtain from the only federally-approved cannabis source for research in the US."



As a result, the company is now seeking additional international suppliers in harmonized countries that produce minor cannabinoids and terpenes to ensure that it can expand testing beyond the initial Phase 0 Trial. Interested parties should contact GB Sciences and Dr. Small-Howard at andrea@gbsciences.com.
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