Intellipharmaceutics Intends to Accelerate its Rexista(TM) Oxycodone XR Development Program on the Basis of Positive Feedback from the FDA
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IntelliPharmaCeutics (IPCI) Pathway for Rexista NDA 'Significantly Shortened', Brean Capital Says
May 21, 2015 11:58 AM EDTBrean Capital analyst Jonathan Aschoff reiterated a Buy rating and $8 price target on IntelliPharmaCeutics International (NASDAQ: IPCI) noting the Rexista NDA pathway was significantly shortened and there will likely be no Phase 3 testing required.
Aschoff commented, "The FDA has provided Intellipharmaceutics with guidance regarding its abuse-deterrent Rexista Oxycodone XR IND, importantly communicating that the company will not need to conduct Phase 3 trials if bioequivalence to Oxycontin is demonstrated. We believe... More
Intellipharmaceutics (IPCI) Not Required to Conduct Rexista Oxycodone XR Phase 3 if Oxycontin Bioequivalence Demonstrated
May 21, 2015 8:04 AM EDTIntellipharmaceutics International (NASDAQ: IPCI) announced that the United States Food and Drug Administration ("FDA") provided the Company with notification regarding its Investigational New Drug Application ("IND") submission for Rexista Oxycodone XR (Abuse Deterrent oxycodone hydrochloride) extended release tablets. The notification from the FDA stated that the Company will not be required to conduct Phase III studies if bioequivalence to Oxycontin is demonstrated.
The Company had earlier announced, on March 30, 2015, that it had submitted an... More
