The authorisation from the Office of Controlled Substances marks the initiation of the treatment phase of the Phase II clinical trial that will be used to support Product License Applications post-legalisation.
Tetra is performing this clinical study to obtain safety and efficacy data to support modern claims for the use of encapsulated cannabis oils in the treatment of chronic pain.
Tetra's programme is designed to build a leading position in the development and commercialisation of cannabis-based natural health products.
Tetra's products are being developed to be compliant with standards expected for pharmaceutical products, which will be supported by scientific and clinical evidence.
PPP005 Phase I clinical trial
Phase I clinical trial to assess safety, tolerability and pharmacokinetics of single and multiple dose of encapsulated cannabis oil (10 mg THC with 10 mg CBD) will be completed soon.
"This study will provide cardiovascular safety data to ensure that the oil formulations can be safely used by consumers. The pharmacokinetic data will provide the data required to define the frequency of dosing needed to avoid inappropriate use that could lead to accumulation of cannabinoids in the body," said Dr Guy Chamberland, MSc, PhD, interim CEO and Chief Scientific Officer.
PPP005 Phase II clinical trial
On 22March 2018, Santé Cannabis, the Montreal-based clinic that is conducting the Phase II clinical trial for Tetra, received authorisation from the Office of Controlled Substances to use the cannabis oil capsules of PPP005 (controlled substance).
This authorisation allowed the Principal Investigator of the trial, Dr Antonio Vigano, to proceed with the clinical trial of PPP005 in chronic pain patients.
This exemption allows Santé Cannabis to prescribe the blinded study medication and for Aphria Inc. to ship blinded products to patient's home under the jurisdiction of the ACMPR.
The screening and enrolment is proceeding faster than expected and will allow Tetra to meet its corporate objectives.
"We are performing this Phase II clinical trial to obtain safety and efficacy data to help drive the sales of encapsulated cannabis oil products for the treatment of chronic pain," added Dr Guy Chamberland.
"We expect chronic pain patients to use cannabis oils, but many of these patients will also be taking opioids or other prescription medications."
"The capability of different doses and ratios of medical cannabis oil to change the amount and type of concomitant medications, such as opioids, used for pain, and the need for rescue pain medication to control chronic non-cancer and cancer pain is evaluated."
"The use of measures that quantify different pain drug regimens used by the patients will help us understand the potential of cannabis oils to be used for opioid sparing. The trial should be completed by autumn 2018."
