Intellipharmaceutics International Inc. (IPCI)

[ahasja]

And here for everyone IPCI's explanation what RexistaTM XR (oxycodone hydrochloride extended release tablets) is:

"The Company’s Rexista™ XR (oxycodone hydrochloride extended release tablets) product candidate is intended as an abuse and alcohol-deterrent controlled-release oral formulation of oxycodone hydrochloride for the relief of pain. Rexista™ XR is an investigational drug, with a unique long acting oral formulation of oxycodone intended to treat moderate-to-severe pain when a continuous, around the clock opioid analgesic is needed for an extended period of time. The formulation is intended to present a significant barrier to tampering when subjected to various forms of physical and chemical manipulation commonly used by abusers. It is also designed to prevent dose dumping when inadvertently co-administered with alcohol. Dose dumping is the rapid release of an active ingredient from a controlled-release drug into the blood stream that can result in increased toxicity, side effects, and a loss of efficacy. Dose dumping can result by consuming the drug through crushing, taking with alcohol, extracting with other beverages, vaporizing or injecting. In addition, when crushed or pulverized and hydrated, the proposed extended release formulation is designed to coagulate instantaneously and entrap the drug in a viscous hydrogel, which is intended to prevent syringing, injecting and snorting. Our RexistaTM XR formulation contains a blue dye that is emitted once the tablet is tampered with or crushed. The blue dye will stain mucous membranes and skin if the product is manipulated and comes in contact with moisture. This stigmatizing blue dye is intended to act as a visible deterrent against inappropriate use if abused orally or via the intra-nasal route." (Taken from the July 05, 2016 NEWS release: https://globenewswire.com/news-release/2016/07/05/853614/0/en/Intellipharmaceutics-Reports-Update-on-Rexista-XR-FDA-Grants-Waiver-of-NDA-Filing-Fee-and-Topline-Pharmacokinetics-Results-Indicate-No-Food-Effect.html )