Inspirion Delivery Technologies (IDT) has announced that last week the company completed a pre-investigational new drug (Pre-IND) meeting with the FDA to determine the clinical and regulatory pathway to advance its abuse deterrent, extended release formulation of oxycodone.
Additionally, the formulation does not ‘dose dump’ in alcohol or other common solvents. The company’s technology allows for flexibility in formulation of release profiles to achieve bio-equivalency to approved and marketed products, as well as the design of unique release profiles to offer dosing and therapeutic advantages to patients.
Stefan Aigner, CEO of IDT, said: “We are very pleased with the outcome of our Pre-IND interaction with the FDA. The FDA was very supportive of our efforts to advance an abuse deterrent oxycodone product. As a result of the feedback we received on our Pre-IND package, we believe we have clear visibility on the required pathway to submit our filing for our abuse deterrent, extended release formulation of oxycodone in a manner that will allow for significant differentiation in the product’s labeling.”