Intellipharmaceutics International Inc. (IPCI)

[numbersarefun]

wimuskyfisherman, Egalet Arymo bioequivalent and skipped Phase 3. Egalet's Arymo just got approved this week. Arymo was bioequivalent to MSContin. Egalet skipped Phase 3. IPCI's Rexista following similar approval pathway.

Rexista is bioequivalent to Oxycontin, so IPCI's NDA would reference Oxycontin's Phase 3. A 505(b)(2) NDA has the right to reference studies of previously approved drugs. So I would say little or no risk of FDA requiring a new Phase 3 done by IPCI.

From ARYMO briefing document:
"Development of Arymo ER for the Proposed Indication Arymo ER was developed under the 505(b)(2) regulatory pathway, which provides for product approval based, in part, on the demonstration of bioequivalence to a reference listed drug (RLD). In two clinical pharmacokinetic (PK) studies, Arymo ER demonstrated bioequivalence to the RLD, MS Contin® (morphine sulfate extended-release tablets), across the proposed dosage range for Arymo (Figure 1). Bioequivalence to MS Contin provides the scientific bridge to safety and efficacy to support regulatory approval, and thus, a Phase 3 study was not required by the Agency."

Link to FDA Advisory Committee's Egalet Arymo briefing document:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM514383.pdf

wimuskyfisherman wrote: "FDA acceptance will be confirmation that a PH3 trial is not required. That is a risk here."