A novel proprietary cannabidiol (CBD) therapeutic has been classified as an orphan medicinal product for epidermolysis bullosa. Tetra Bio-Pharma says the drug is now ready for human clinical trials.
The cannabinoid-derived drug discovery and development company Tetra Bio-Pharma Inc announced yesterday (18 May) that its CBD-containing topical preparation, PP004 has received Orphan Drug Designation from the European Medicines Agency (EMA).
The European Medicines Agency (EMA) has classified the novel therapeutic as an orphan medicinal product for the treatment of epidermolysis bullosa (EB). The designation represents the product’s third orphan drug designation as a treatment for EB, a group of rare medical conditions that result in blistering of the skin and mucous membranes. The severity of the condition, which has no cure, can range from mild to fatal with treatment focusing on caring for blisters and preventing new ones.
“This important designation is a milestone in the development of PPP004 as Tetra continues to execute its regulatory strategy in Europe. It also highlights the critical need for effective treatment options for people living with EB”, said Dr Guy Chamberland, Chief Executive Officer and Chief Regulatory Officer at Tetra Bio-Pharma.
PPP004 is a topical preparation containing either a standardized amount of CBD or a defined ratio of THC and CBD. The product was developed to help manage pain and itch in patients with EB and promote wound healing.
EMA Orphan Drug Designation is granted to investigational therapies intended to treat, prevent, or diagnose life-threatening or chronic debilitating conditions or conditions that affect fewer than 5 in 10,000 people in European Union. An ODD brings several unique advantages, the company said, including cost reduction in drug development, an accelerated review process and market exclusivity for ten years.
Tetra Bio-Pharma specialises in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers.
