IPCI - Intellipharmaceutics Intends To Accelerate Its Rexista(TM) Oxycodone XR Development Program On The Basis Of Positive Feedback From The FDA
TORONTO, May 21, 2015 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today 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(TM) 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(TM) is demonstrated.
The Company had earlier announced, on March 30, 2015, that it had submitted an IND to the FDA for Rexista(TM) Oxycodone XR in anticipation of the commencement of Phase III clinical trials. At the same time the Company had also announced that topline data results of three definitive Phase I pharmacokinetic clinical trials (single dose fasting, single dose steady-state fasting, and single dose fed) all met the bioequivalence criteria when compared to the existing branded drug Oxycontin(TM). The Company believes, in light of these prior results, that it will not be required to conduct Phase III studies, although no assurance to that effect can be given.
The Company believes the FDA notification is significant as it provides a basis for an accelerated development plan for its Rexista(TM) Oxycodone XR product candidate, without the need for more costly and time-consuming Phase III studies. The Company intends to file a New Drug Application ("NDA") for Rexista(TM) Oxycodone XR (Abuse Deterrent oxycodone hydrochloride) extended release tablets with the FDA within the next 6 to 12 months, although no assurance to this effect can be given. Further, there can be no assurance that the FDA will ultimately approve the NDA for sale of Rexista(TM) Oxycodone XR in the U.S. market, or that it will ever be successfully commercialized.
"We are thrilled with the FDA's positive acknowledgement, which enables us to accelerate the development and commercialization of our abuse deterrent Rexista(TM) Oxycodone XR product candidate," stated Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics. "The avoidance of a Phase III trial eliminates a significant financial hurdle. More importantly, it shortens the development timeline and potential time to market."
Rexista(TM) Oxycodone XR
Rexista(TM) Oxycodone XR is the Company's non-generic extended release formulation intended for the management of moderate to severe pain when an around-the-clock analgesic is required. The formulation is intended to present a significant barrier to tampering when subjected to various forms of anticipated physical and chemical manipulation commonly used by abusers. It is also designed to prevent dose dumping when inadvertently or intentionally co-administered with alcohol. 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 or snorting.
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