Intellipharmaceutics Updates On Rexista Oxycodone Development Program

(RTTNews) - Intellipharmaceutics International Inc. (IPCI, I.TO), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, announced an update on the events in its Rexista oxycodone development program.

The physico-chemical tests were conducted on either an intact, pulverized or microwaved Rexista oxycodone.

The physico-chemical studies suggest that Rexista oxycodone should be difficult to abuse through crushing, chewing or licking; Release of oxycodone from Rexista oxycodone is likely to be slower or not instantaneous in a range of beverages and solvents; Rexista oxycodone should not "dose dump", or instantaneously release the entire dose of oxycodone, in the presence of ethanol over a range of concentrations.

The accelerated stability studies indicate that Rexista oxycodone formulation is stable even at a high temperature (40°C) and relative humidity (70%) of storage.

The company noted that the study suggested that utilization of the technology platform in its formulation of Rexista oxycodone does not interfere with the bioavailability of oxycodone, and promotes the stability of Rexista oxycodone.

The company believes that Rexista oxycodone is also sufficiently differentiated from currently available commercial oxycodone hydrochloride extended-release products, both in its design architecture and by having the release of the active substance, oxycodone, show a point of divergence in a dissolution profile and/or a bioavailability profile.

The company stated that it plans to seek a Special Protocol Assessment or "SPA" from the United States Food and Drug Administration or "FDA" to assist us in our plans to conduct a pivotal Phase III study in preparation for a New Drug Application or "NDA" 505(b)(2) application. The purpose of the SPA is to reach an agreement with the FDA regarding the study design, endpoints and statistical analyses needed to support approval of Rexista oxycodone prior to initiating the Phase III study.

In addition, the company said it will also be seeking a licensing partner for the Phase III studies. Intellipharmaceutics' previously announced development goals for 2013 included the completion of Phase I studies of Rexista oxycodone. The company noted that it currently expect to carry out additional Phase I studies by the fourth-quarter of 2013, and to initiate Phase III trials by the first half of 2014.

The company added that Rexista oxycodone is an investigational drug, with a unique long acting oral formulation of oxycodone intended to treat moderate-to-severe pain when a continuous, around the clock opioid analgesic is needed for an extended period of time.