Published on September 30, 2009 at 8:52 AM
Inspirion Delivery Technologies, LLC ("IDT") announced today that last week the Company completed a pre-investigational new drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) to determine the clinical and regulatory pathway to advance its abuse deterrent, extended release formulation of oxycodone.
Typical opioids provide abusers with multiple pathways to abuse, including crushing, smashing, chewing, grinding, or dissolving in alcohol or other solvents. This tampering results in rapid and potent euphoric highs that can lead to dependence, drug craving, diversion, addiction, and fatal overdoses. Using a unique, patented, multi-layer design, IDT's abuse deterrent technology eliminates the majority of these pathways of abuse by restricting absorption if the tablet is physically damaged. This results in comparable blood levels when the tablet is damaged and ingested orally, as well as significantly lower levels if snorted or injected. 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.
"We are very pleased with the outcome of our Pre-IND interaction with the FDA," commented Dr. Stefan Aigner, CEO of IDT. "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."
SOURCE Inspirion Delivery Technologies, LLC