New Dronabinol Formuations
Present Commercial
Dronabinol Gel-cap Formulations
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Poor and erratic absorption due to insolubility, with some patients achieving very high levels and others achieving very low levels.
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Rapid and extensive first-pass liver metabolism, resulting in low blood levels and a relatively short half-life (approximately 2 - 3 hours) which is not optimally suited for therapeutic indications requiring blood levels to be sustained for 6 hours or longer.
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Undesirable side effects from high dosage strength required to achieve sustained, therapeutic blood levels
New Lipid Based Dronabinol Formula
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Strident goals achieved on bench scale
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About to begin scaled up manufacturing with AB Initio
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Worldwide patents pending
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Potential for use in other indications for dronabinol
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Potentially applicable for other insoluble compounds
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Excipients can even be used in OTC applications
Dronabinol Development Status
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Positive Phase 2A & 2B studies in the treatment of OSA
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Using the 505(b)(2) regulatory approach in the U.S., existing labelling information of an approved Listed Druge (Marinol) and/or published literature may be used to meet certain regulatory requirements for product approval.
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Joint development agreement with Noramco/Purisys for API
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New propietary formulation about to be GMP manufactured for clinical PK/PD studies
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Services agreements with iNGENu CRO, RespireRX and Ab Initio