Dr. Isa Odidi reports

INTELLIPHARMACEUTICS REPORTS POSITIVE RESULTS FROM A SERIES OF PHASE I CLINICAL TRIALS OF REGABATIN XR (PREGABALIN EXTENDED-RELEASE)

IntelliPharmaCeutics International Inc. has provided an update on the progress of its Regabatin XR product development. Regabatin XR pregabalin extended-release capsules are the company's non-generic pregabalin formulations. The company intends to present the following information arising from its Regabatin XR product development program at the coming American Association of Pharmaceutical Scientists annual meeting and exposition in San Diego from Nov. 2 to 6, 2014.

The company has recently conducted and analyzed the results of six phase 1 clinical trials involving a twice-a-day formulation and a once-a-day formulation. For formulations directed to certain indications, which include fibromyalgia, the results suggested that Regabatin XR 82.5-milligram twice-a-day dosage was comparable in bioavailability with Lyrica 50-milligram (immediate-release pregabalin) three-times-a-day dosage. For formulations directed to certain other indications, which include neuropathic pain associated with diabetic peripheral neuropathy, the results suggested that Regabatin XR 165-milligram once-a-day dosage was comparable in bioavailability with Lyrica 75-milligram BID dosage. Pregabalin is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, spinal cord injury and fibromyalgia. A controlled-release version of pregabalin should reduce the number of doses patients take, which could improve patient compliance, and therefore possibly enhance clinical outcomes. Lyrica pregabalin, BID and TID, is a drug product marketed in the United States by Pfizer Inc.

Each study was structured as an open-label, balanced, randomized and crossover oral bioavailability study. Taking the Regabatin XR 165-milligram once-a-day product as an example, following single-dose administration of Regabatin XR 165 milligrams versus Lyrica 75 milligrams BID under fed conditions, bioequivalence criteria were met for Cmax. Under multiple-dose administration of Regabatin XR 165 milligrams versus Lyrica 75 milligrams BID, Regabatin XR 165 milligrams met bioequivalence criteria for both Cmax.

Those results also suggested that Regabatin XR 165 milligrams once a day has a higher exposure during the first 12 hours than Lyrica 75 milligrams BID. Together with the symptomatology and chronobiology of fibromyalgia, this could prove to be advantageous with evening meal dosing and suggests that once-a-day Regabatin XR 165 milligrams once a day may confer a compliance advantage over Lyrica 75 milligrams BID, which is currently administered for treatment of fibromyalgia.

Plans are under way to initiate an investigational new drug application under the new drug application 505 (b) (2) regulatory pathway with the U.S. Food and Drug Administration, with a view to possible commercialization in the United States following the Dec. 30, 2018, expiry of the patent covering the pregabalin molecule. According to Source Healthcare Analytics, U.S. sales for the 12 months ended August, 2014, for Lyrica (pregabalin capsules) in all strengths were approximately $3.0-billion, expressed in TRx MBS dollars as defined in the company's latest Form 20-F. There can be no assurance that additional clinical trials will meet the company's expectations, that the company will have sufficient capital to conduct such trials, that the company will be successful in submitting an NDA 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.

"We are excited with the positive results of the phase 1 studies, utilizing formulations and dosages of our Regabatin XR product candidate," stated Dr. Isa Odidi, chief executive officer and co-founder of IntelliPharmaCeutics. "To the best of our knowledge, at present, there is no once-daily pregabalin product, nor is there one designed to provide higher early exposure following its oral administration, a factor which may prove beneficial to fibromyalgia patients. We plan to move forward, subject to FDA guidance, into phase III and also to explore our potential strategic business development activities for this product."

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