Australian Regulator approves MDMA for PTSD treatment

Clintex CTi
3 min readJul 13, 2023

Australia made history on July 1, 2023, when it became the first country in the world to prescribe MDMA and psilocybin for therapeutic use. The Therapeutic Goods Administration (TGA), Australia’s medicines regulator, approved the use of MDMA for the treatment of post-traumatic stress disorder (PTSD) and psilocybin for treatment-resistant depression.

The decision to approve these drugs for therapeutic use was based on the results of clinical trials that showed that both MDMA and psilocybin can be effective in treating these conditions. In the case of MDMA, the drug was shown to be effective in reducing the symptoms of PTSD in people who had not responded to other treatments. Psilocybin, on the other hand, was shown to be effective in reducing the symptoms of treatment-resistant depression in people who had not responded to other treatments.

The adoption of the use of these drugs in Australia is great news for the Clintex team as we eagerly await the start of the LVL CANPAIN trial. The movement in other novel forms of treatment for other coditions can only benefit the CANPAIN trial and everybody involved including Clintex.

LVL Health, a clinical-stage pharmaceutical company developing novel treatments for chronic pain, last year announced a collaboration with Clintex CTI. Clintex will provide its expertise and insights to LVL Health’s CANPAIN trial, a Phase 2b trial evaluating the efficacy and safety of LVL-101 for the treatment of chronic pain.

Opioids are a class of drugs that are used to treat pain. They are very effective, but they can also be addictive and dangerous. In recent years, there has been an epidemic of opioid addiction and overdose. Cannabinoids are a class of compounds that are found in the cannabis plant. They have a variety of effects on the body, including pain relief, anti-inflammation, and appetite stimulation. CBMPs, or Cannabinoid-Based Medicines, are products that are made from cannabinoids.

There is growing evidence that CBMPs can be effective in treating pain and can eventually replace a large amount of the need for opioid treatment. If CBMPs are shown to be safe and effective in treating pain, they could potentially reduce the need for opioids. This would be a major public health victory, as it would help to curb the opioid epidemic.

LVL are at the forefront of this amazing study and the Clintex team are ecstatic to assisting in this area we are all so passionate about.

Whilst we await the LVL trial to commence, ongoing development continues of our CTAi app, allowing clinicians to explore and interact with their clinical data, without the need for bespoke programming each time. This will greatly enhance decision making during a clinical trial and will give direct benefit to partners like LVL. We will provide ongoing updates during Q3 and beyond.

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Clintex CTi

Clinical Trials Intelligence is a data management software solution for the clinical trials industry that leverages distributed ledger technology