- Avecho Biotechnology (AVE) passes a “crucial” two-year stability milestone for its TPM-enhanced cannabidiol (CBD) soft-gel capsule
- The capsule spent two years at room temperature, with no significant changes or degradation to the drug or the capsule’s physical attributes
- CBD levels remained stable at 99.5 per cent of the label’s claim, supporting the product’s two-year shelf life upon TGA approval
- This milestone means the company can move on to its phase three clinical trial for the capsule bringing the drug one step closer to registration
- Shares last traded at 0.5 cents
Avecho Biotechnology (AVE) has passed a “crucial” two-year stability milestone for its TPM-enhanced cannabidiol (CBD) soft-gel capsule.
Formulation development work for the TPM-enhanced capsule was completed in May 2021. The capsule spent two years at room temperature, with no significant changes or degradation to the drug or the capsule’s physical attributes.
Meanwhile, CBD levels remained stable at 99.5 per cent of the label’s claim, supporting the product’s two-year shelf life upon TGA approval.
AVE’s capsule contains 75 milligrams (mg) of CBD, complying with the TGA’s guidelines, with no future over-the-counter CBD products allowed to have a daily dose of more than 150 mg of CBD.
CBD products that don’t remain stable for a minimum of two years are unable to be registered as pharmaceutical medicines under the Therapeutic Goods Association (TGA) and Food and Drug Administration (FDA).
This milestone means the company can move on to its phase three clinical trial for the capsule, with 540 patients set to be enrolled over the eight-week study bringing the drug one step closer to registration.
Avecho shares last traded at 0.5 cents.