Australian firm seeks approval for world's first THC-free CBD pain tablet
Promethean BioPharma has submitted a zero-THC CBD pain-relief tablet to the Therapeutic Goods Administration, aiming for registration within six months.
Promethean BioPharma finished clinical testing of a cannabis-derived tablet that delivers pain relief without any THC and has filed the product with the Therapeutic Goods Administration for registration, a process expected to last about six months. The trial involved 155 participants, including a few with pre-existing heart-rhythm risks, and reported that roughly 10% were high responders experiencing meaningful relief from the first week.
Approval would make the tablet the first prescription CBD pain medication worldwide, allowing doctors to prescribe it more easily and potentially paving the way for over-the-counter sales. The company hopes Australian registration will support future applications in the United Kingdom, Canada and Germany. Peter Comerford highlighted backing from the National Reconstruction Fund Corporation for the next development stage, emphasizing the broader significance for Australian science and industry.
Why it matters
A first-in-class CBD pain tablet could change pain management and boost Australia's pharmaceutical sector.
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