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Intellipharmaceutics up on accelerated approval path for Rexista

  • Thinly traded nano cap Intellipharmaceutics (IPCI +17.3%) heads north on a 10x surge in volume in response to its announcement that the FDA may not require a Phase 3 study for its abuse-deterrent opioid candidate, Rexista Oxycodone XR, if bioequivalence to Purdue Pharma's Oxycontin is demonstrated. The company believes that its previously completed Phase 1 trials fulfill this criterion.
  • The firm intends to file its New Drug Application (NDA) within the next 6 - 12 months. Approval is not guaranteed, however. After reviewing the data, the FDA may still require further studies.
  • Rexista Oxycodone XR's formulation deters abuse by instantaneously coagulating and entrapping the drug in a viscous hydrogel when pulverized and hydrated. It is also designed to prevent dose dumping if taken with alcohol.
  • Related tickers: (PTIE -1.9%)(DRRX)(COLL +1.9%)(ZGNX)(MNK -0.3%)(ACT +1.1%)(TEVA +1.6%)(ABBV -0.7%)(LCI -0.7%)(ALKS -1%)(OTC:EGLT -0.1%)(PFE -0.2%)(OTC:ACUR -2.4%)

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Intellipharmaceutics International Inc.
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