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Incannex Healthcare - On the road to mainstream acceptance

The Therapeutic Goods Administration (TGA), the Australian regulatory authority, has announced it will permit psychiatrists to prescribe (off-label) therapeutics containing psilocybin (for treatment-resistant depression, TRD) and MDMA (for post-traumatic stress disorder, PTSD), which we deem to be a landmark decision (effective 1 July). We view this as a step toward softening the stigma attached to the use of psychedelic drugs, which is critical for broader provider/patient acceptance. There is growing clinical evidence of the utility and efficacy of these drugs to treat mental illness, an unmet space characterized by high relapse rates and therapeutic resistance. Incannex Healthcare's program for generalized anxiety disorders (GAD) is currently in an ongoing Phase II study (Psi-GAD). We note that the FDA has already granted the ‘breakthrough therapy’ designation to two ongoing psilocybin clinical programs in the United States and real-world patient data from Australia may further support regulatory decision-making.