Clinical trials of cannabis sublingual wafers begin this week after approval by the TGA
A clinical trial of a unique ‘cannabis wafer product’ has been approved by the TGA, with first patient visits commencing on Tuesday.
Developer and distributor of skincare and health supplements, Bod Australia, announced the commencement of its Phase I Clinical trial to test the safety, tolerability and pharmacokinetics of a phytocomplex cannabis extract suspended in a sublingual wafer.
The product is the unique combination of a phytocomplex cannabis extract sourced from Swiss pharmaceutical company Linnea, which is suspended in iX Biopharma’s patented sublingual wafer (WaferiX).
This small wafer, formulated using a proprietary freeze-drying process, is intended to be placed under the consumer’s tongue.
It dissolves within one minute, releasing active compounds for rapid absorption.
“Sublingual wafer administration offers the convenience of use over oral delivery, circumventing the drug breakdown in liver or gastrointestinal tract,” explains iX Biopharma.
“The technology also provides rapid absorption, achieving maximum desirable therapeutic effect in a non-invasive manner.”
Wafer administration leaves no after-taste, residue or grittiness under the tongue, explains Bod, preventing the urge for recipients to swallow.
Other products on the market include oromucosal sprays that contain cannabinoid extracts.
Recent trials of competing cannabis-based medicines include those of NanaBis and NanaBidial, which are administered by Medlab’s patented NanoCelle nano-particle spray to the inside of the cheek.
The objective of the WaferiX trial is to test the safety and tolerability of the finished product, says Bod.
A second trial segment will begin in August, and Bod expects its Phase I Clinical trial to be completed by November 2018.
Post completion of the Phase I, focus will shift to testing for globally significant, specific indications for the finished product including chemotherapy-associated nausea and vomiting, multiple sclerosis, epilepsy, anti-inflammation treatment and anxiety.
Bod says it is actively pursuing licencing and partnership agreements with leading institutions as trial process progresses, with partnerships to assist in subsidising trial costs.
“We are thrilled to have commenced our Phase I Clinical trial to test our proprietary phytocomplex cannabis extract ECs315 and unique patented delivery method,” says Bod Australia CEO Jo Patterson.
“The company has achieved a number of milestones to date, including product formulation, patient recruitment and granting of all necessary regulatory approvals, and look forward to first patient visits today.
“As the trial progresses, Bod will continue to explore ways in which we can leverage our cannabis product innovations through partnerships and collaborations with key researchers.
“Further, the Company will continue to progress opportunities to sell, licence and distribute our finished sublingual wafer product.”
Interest in medicinal cannabis products has ramped up since the Federal Government approved its supply via GPs early last year.
Access to medicinal cannabis is available through:
Meanwhile state governments have been urging the Federal Government to list medicinal cannabis products on the PBS.
“Victoria’s leadership has seen some of our sickest kids get the treatment they so desperately need,” said Victorian Health Minister Jill Hennessy in January this year.
“We urge the Turnbull Government to move quickly so that this life changing product is affordable and in-reach for every Australian – not just those who can afford it.”
Imported medicinal cannabis has been offered to 29 children with severe intractable epilepsy in the state.
This scheme was consequently expanded to reach 60 of the state’s sickest children.