IntelGenx Achieves Positive Bioequivalence Results for Erectile Dysfunction Film Product
SAINT LAURENT, QUEBEC, Sep 02, 2010 (MARKETWIRE via COMTEX) -- IntelGenx Corp. ("IntelGenx") today announced the completion of a pilot study that indicates that IntelGenx has successfully developed a novel oral film, INT007, that is bioequivalent to a leading branded tablet containing a phosphodiesterase type 5 (PDE-5) inhibitor for the treatment of erectile dysfunction. INT007 has been developed using IntelGenx' proprietary immediate release "VersaFilm" drug delivery technology.
This was a randomized, two-period, two-way crossover study in healthy male subjects. The study was designed to determine whether INT007 was bioequivalent to a leading branded PDE-5 inhibitor tablet as measured by industry standard pharmacokinetic measures, peak plasma concentration (Cmax) and area under the curve (AUC). The study results demonstrated that INT007 was within the range of bioequivalency on both of these measures. The study also measured time to peak concentration (Tmax), a common determinant of rate of absorption. IntelGenx' INT007 film achieved Tmax 27% quicker than the oral tablet formulation, indicating a potentially faster onset of action.
"The achievement of bioequivalence in this pilot study solidifies IntelGenx' position at the forefront of immediate release film development," said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "This is the second VersaFilm project that we progressed into the clinic, and the second VersaFilm project that has yielded positive bioequivalence results. Furthermore this study has demonstrated not only bioequivalence but also a faster onset of action, which could be another advantage versus the current tablet formulation."
Following the successful completion of the pilot study, the Company plans to commence scale-up and manufacturing of the pivotal batches required to support a pivotal clinical study and future regulatory 505(b)(2) filing.
About IntelGenx Corp.:
IntelGenx Corp. is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx' research and development pipeline includes products for the treatment of pain, hypertension, erectile dysfunction and depressive disorders. More information is available about the company at www.intelgenx.com.