FDA has granted Orphan Drug Designation to the active ingredients of the PPP001 drug for the treatment of complex regional pain syndrome (CRPS), according to a release1 issued by developer Tetra Bio-Pharma (Orleans, Ontario, Canada). The PPP001 drug is a delta-9-tetrahydrocannabinol (9.5%) and cannabidiol (2.5%), a dried cannabis pellet for use in an inhalation device formulated from three strains of standardized dried cannabis (9.5% THC, 2.5% CBD).
Tetra Bio-Pharma, a biopharmaceutical company based in cannabinoid drug discovery and clinical development, has been focused on research, pharmaceutical promotion, and retail commercialization of cannabinoid-based products. The company recently completed a successful placebo-controlled Phase 1a and 1b study of PPP001 in healthy volunteers, demonstrating drug safety.1 According to Tetra, the drug also hopes “to be the first smokable marihuana for advanced cancer pain under prescription.”
FDA’s Orphan Drug Designation program provides orphan status to those medications intended to treat diseases or disorders that affect less than 200,000 people in the United States.2 Upon approval, Tetra is allowed a seven-year marketing exclusivity. The Orphan Drug Designation was granted for the active moiety of the PPP001 drug, and not the formulation.1
“We are pleased to receive FDA Orphan Drug Designation for PPP001 and we look forward to discussing the clinical program with the FDA that will be used to demonstrate the safety and efficacy in patients suffering from CRPS,” said Guy Chamberland, PhD, chief scientific officer at Tetra Bio-Pharma.
CPRS patients typically use more than one pain medication to combat the disease. Previous medications that have performed well in clinical trials for CPRS include:
- oral steroids
- the anti-seizure drug gabapentin (for example, Neurontin)
- the hormone calcitonin (in a nasal spray)
- topical patches and creams