TORONTO, July 15, 2013 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), 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 an update on the following events in its Rexista™ oxycodone development program:
1) The results of the current stage of development and physico-chemical tests to assess abuse-deterrent properties of its Rexista™ oxycodone
2) Stability studies
3) Successful Phase I clinical trial of its Rexista™ abuse-deterrent oxycodone, designed around its proprietary drug delivery system.
The physico-chemical tests were conducted on either an intact, pulverized or microwaved Rexista™ oxycodone and included:
- Crush resistance studies conducted to evaluate the potential for abuse by chewing and licking of Rexista™ oxycodone;
- Alcohol challenge studies conducted to evaluate the potential for "dose dumping" related to inadvertent or deliberate co-administration of Rexista™ oxycodone with alcohol;
- Extraction studies in beverages, aqueous and non-aqueous media conducted to evaluate the potential for abuse related to oral administration of oxycodone obtained from dissolved Rexista™ oxycodone;
- Vaporization studies conducted to evaluate the potential for abuse related to insufflation of oxycodone obtained from heating of Rexista™ oxycodone; and
- Syringeability and injectability studies conducted to evaluate the potential for abuse related to intravenous administration of oxycodone obtained from dissolved, pulverized or microwaved Rexista™ oxycodone.
Results from such 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;
- Rexista™ oxycodone when pulverized and reduced to particles should be difficult and time consuming to syringe or inject in the form and volume suitable for intravenous administration;
- Release of oxycodone should be insignificant or inefficient via heating and vaporization;
- Extraction of oxycodone from Rexista™ oxycodone which has been microwaved should be difficult or inefficient; and
- Rexista™ oxycodone when pulverized or reduced to particles should be difficult or inefficient to snort or inhale.
Results from accelerated stability studies indicate that Rexista™ oxycodone formulation is stable even at a high temperature (40°C) and relative humidity (70%) of storage.
The successful Phase I clinical trial, on twelve subjects in a fasted state, was a randomized, cross-over, comparative bioavailability clinical trial of Rexista™ oxycodone in comparison with OxyContin® (oxycodone hydrochloride controlled-release tablets). The outcome was positive, and showed that a single dose of our 40 mg Rexista™ oxycodone was bio-comparable to 40 mg OxyContin®. The bioavailability of a single dose of Rexista™ oxycodone was equivalent to that of OxyContin®, as measured by the respective areas under the curve ("AUCs"). The value for AUC essentially provides an estimation of total drug exposure by comparing ratios between Rexista™ oxycodone and OxyContin®. On an industry measurement basis, these may be summarized as AUCt = 92% and AUCinf = 99%. These ratios were within 80% - 125% at the 90% confidence interval. We had previously reported a successful proof of concept Phase I study in which a single dose of a Rexista™ oxycodone 40 mg formulation was compared to OxyContin® 20 mg administered twice.
"The study suggests that utilization of the technology platform in our formulation of Rexista™ oxycodone does not interfere with the bioavailability of oxycodone, and promotes the stability of Rexista™ oxycodone," stated Dr. Isa Odidi, CEO and Co-Founder of Intellipharmaceutics. "We believe that our 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. This represents a point or segment in a plasma concentration timeline where the history of the dissolution or release rate changes from a higher release rate during onset of action to another lower rate during the phase of controlled release or sustained action."
We plan to seek a Special Protocol Assessment ("SPA") from the United States Food and Drug Administration ("FDA") to assist us in our plans to conduct a pivotal Phase III study in preparation for a New Drug Application ("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. We 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. We currently expect to carry out additional Phase I studies by the 4th quarter of 2013, and to initiate Phase III trials by the first half of 2014.
For the SPA, we intend to propose a pivotal Phase III study designed as a randomized, double-blinded, placebo-controlled, multi-center study to evaluate the analgesic efficacy of Rexista™ oxycodone in comparison to a placebo over a 12-week treatment period in patients having pain intensity scores corresponding to moderate-to-severe pain. There can be no assurance that additional clinical trials will meet the expected outcomes, or that we will be successful in submitting an NDA 505(b)(2) filing with the FDA, that the FDA will approve this product candidate for sale in the U.S. market, or that it will ever be successfully commercialized.
About Rexista™ Oxycodone
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. Rexista™ oxycodone is designed to discourage common methods of tampering associated with misuse and abuse of such prescription opioid analgesic.
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of product candidates in various stages of development, including filings with the FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
Certain statements in this document constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and/or "forward-looking information" under the Securities Act (Ontario). These statements include, without limitation, statements expressed or implied regarding our plans, goals and milestones, status of developments or expenditures relating to our business, plans to fund our current activities, statements concerning our partnering activities, health regulatory submissions, strategy, future operations, future financial position, future sales, revenues and profitability, projected costs, and market penetration. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue," "intends," "could," or the negative of such terms or other comparable terminology. We made a number of assumptions in the preparation of our forward-looking statements. You should not place undue reliance on our forward-looking statements, which are subject to a multitude of known and unknown risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those stated in or implied by the forward-looking statements. Risks, uncertainties and other factors that could affect our actual results include, but are not limited to, the effects of general economic conditions, securing and maintaining corporate alliances, our estimates regarding our capital requirements, and the effect of capital market conditions and other factors, including the current status of our product development programs, on capital availability, the potential dilutive effects of any future financing, our programs regarding research, development and commercialization of our product candidates, the timing of such programs, the timing, costs and uncertainties regarding obtaining regulatory approvals to market our product candidates, and the timing and amount of any available investment tax credits, the actual or perceived benefits to users of our drug delivery technologies and product candidates as compared to others, our ability to maintain and establish intellectual property rights in our drug delivery technologies and product candidates, the actual size of the potential markets for any of our product candidates compared to our market estimates, our selection and licensing of product candidates, our ability to attract distributors and collaborators with the ability to fund patent litigation and with acceptable development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts, sources of revenues and anticipated revenues, including contributions from distributors and collaborators, product sales, license agreements and other collaborative efforts for the development and commercialization of product candidates, our ability to create an effective direct sales and marketing infrastructure for products we elect to market and sell directly, the rate and degree of market acceptance of our products, the timing and amount of insurance reimbursement for our products, the success and pricing of other competing therapies that may become available, our ability to retain and hire qualified employees, and the manufacturing capacity of third-party manufacturers that we may use for our products. Additional risks and uncertainties relating to the Company and our business can be found in the "Risk Factors" section of our latest annual information form, our latest Form 20-F, as amended, and our latest Form F-3 (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S. The forward-looking statements are made as of the date hereof, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Source:Intellipharmaceutics International Inc.