IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, provided an update on its RexistaTM XR (oxycodone hydrochloride extended release tablets) new drug application (“NDA”) candidate.
NDA Filing Fee Waiver
In February 2016, Intellipharmaceutics requested a waiver of the application user fee under the small business waiver provision, section 736(d)(1)(D) of the Federal Food, Drug, and Cosmetics Act (the “Act”), related to our RexistaTM XR (oxycodone hydrochloride extended release tablets) NDA product candidate. The United States Food and Drug Administration (“FDA”) has completed its review of our request and has granted a waiver of the $1,187,100 application fee for RexistaTM XR.
Pharmacokinetics Results Show No Food Effect
Following an FDA request that we assess the food effect of the final to be marketed (upon FDA approval) product of RexistaTM XR, Intellipharmaceutics recently conducted and analyzed the results of a food effect study for RexistaTM XR. The study design was a randomized, one-treatment two periods, two sequences, crossover, open label, laboratory-blind bioavailability study for RexistaTM XR following a single 80 mg oral dose to healthy adults under fasting and fed conditions.
The food effect study showed that RexistaTM XR can be administered with or without a meal (i.e., no food effect). RexistaTM XR met the bioequivalence criteria (90 percent confidence interval of 80 to 125 percent) for all matrices, i.e., on the measure of maximum plasma concentration or Cmax, the ratio of RexistaTM XR taken under fasted condition to RexistaTM XR taken under fed condition was 112.79 percent (90 percent confidence interval of 102.75 to 123.8 percent) and on the measure of area under the curve from time zero to time t (AUCt) the ratio of RexistaTM XR taken under fasted condition to RexistaTM XR taken under fed condition was 99.99 percent (90 percent confidence interval of 95.24 to 104.99 percent) and on the measure of area under the curve from time zero to time infinity (AUCinf) the ratio of RexistaTM XR taken under fasted condition to RexistaTM XR taken under fed condition was 100.70 percent (90 percent confidence interval of 94.64 to 107.15 percent).
Dr. Isa Odidi, Chairman and CEO, stated, “The FDA waiver of the NDA application fee is a welcome decision in our development of Rexista™ XR. In addition, we believe the food effect studies demonstrate that RexistaTM XR taken under fasted and fed conditions is bioequivalent for all pharmacokinetic matrices studied and has no food effect, and that RexistaTM XR is well differentiated from currently marketed oral oxycodone extended release products, one of which is labelled to be taken with food due to food effects and the other whose Cmax matrix has been reported not to be bioequivalent under fasting and fed conditions. The Company plans to file the NDA for RexistaTM XR in August of 2016.”
There can be no assurance that we will not be required to conduct further studies for RexistaTM XR, that we will continue to satisfy the criteria for the waiver of the application fee, that we will file an NDA for RexistaTM XR in August 2016, that the FDA will ultimately approve the NDA for the sale of RexistaTM XR in the U.S. market, or that it will ever be successfully commercialized. (Original Source)
Shares of Intellipharmaceutics International closed last Friday at $1.57, up $0.02 or 1.29%. IPCI has a 1-year high of $3.87 and a 1-year low of $1.41. The stock’s 50-day moving average is $1.60 and its 200-day moving average is $2.02.
Intellipharmaceutics International, Inc. is a pharmaceutical company, which specializes in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. Its patented Hypermatrix technology is a multidimensional controlled-release drug delivery platform that can be applied to the development of existing and new pharmaceuticals in the areas of neurology, cardiovascular, gastrointestinal tract, diabetes and pain. The company was founded on October 22, 2009 and is headquartered in Toronto, Canada.