- Intellipharmaceutics (OTC:IPCI) successfully completes its bioequivalence studies between Rexista Oxycodone XR (abuse-deterrent oxycodone hydrochloride) and Purdue Pharma's Oxycontin (oxycodone hydrochloride). The design of the trials, based on FDA recommendations, compared the lowest and highest strengths of the two medications. The resultant ratios of pharmacokinetic metrics were within the intervals required by the agency.
- Per FDA guidance, the company will not have to conduct Phase 3 studies if bioequivalence was demonstrated. It intends to file a New Drug Application (NDA) within the next six months using the abbreviated 505(b)(2) pathway.
- When Rexista is crushed or pulverized and hydrated, it coagulates instantaneously into a viscous hydrogel which prevents snorting or injecting.
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Update: Shares are up 26% premarket on increased volume.