Intellipharmaceutics said that the successful manufacture of clinical batches is required to make the drug eligible for Phase I studies and to establish a clinical program in cooperation with the FDA in order to facilitate advancement of the drug through the application process.
Intellipharmaceutics said that the drug delivery platform, Rexista, produces a dosage form designed to be deterrent to the well-documented abuses associated with currently marketed oxycodone products, such as the abuse of these drugs by nasal inhalation when crushed or powdered, and by injection when combined with solvents. Rexista products are also designed to deter release of the entire dose when consumed with alcohol, a problem with some opioid drugs.
Isa Odidi, CEO of Intellipharmaceutics, said: “The qualification of this equipment involved the very difficult design and modification of certain aspects of the equipment to accommodate the new and proprietary dosage form which we have developed for our Rexista drug program, namely a paste in a capsule.
“We have now commenced the manufacture of clinical batches of our oxycodone CR product using this new delivery platform.”