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New Dronabinol Formuations

Present Commercial

Dronabinol Gel-cap Formulations

  • Poor and erratic absorption due to insolubility, with some patients achieving very high levels and others achieving very low levels.

  • 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.

  • Undesirable side effects from high dosage strength required to achieve sustained, therapeutic blood levels

New Lipid Based Dronabinol Formula

  • Strident goals achieved on bench scale

  • About to begin scaled up manufacturing with AB Initio

  • Worldwide patents pending

  • Potential for use in other indications for dronabinol

  • Potentially applicable for other insoluble compounds

  • Excipients can even be used in OTC applications

Dronabinol Development Status

  • Positive Phase 2A & 2B studies in the treatment of OSA

  • 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.

  • Joint development agreement with Noramco/Purisys for API

  • New propietary formulation about to be GMP manufactured for clinical PK/PD studies

  • Services agreements with iNGENu CRO, RespireRX and Ab Initio

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