SAINT LAURENT, Canada I February 24, 2014 I IntelGenx Corp. (IGX.V) (IGXT) (“IntelGenx”), a Canadian drug delivery company focusing on oral drug delivery, today announced the completion of a pilot biostudy with its proprietary VersaFilm(TM) tadalafil product for erectile dysfunction that indicated bioequivalence with the leading brand reference listed drug (RLD) tadalafil product.
This was a randomized, two-period, two-way crossover study in healthy male subjects. The study was designed to determine whether VersaFilm(TM) tadalafil was bioequivalent as measured by industry standard pharmacokinetic measures of peak plasma concentration (Cmax) and area under the curve (AUC). The study results demonstrated that VersaFilm(TM) tadalafil was within an acceptable range of bioequivalency with the RLD on both of these measures.
“The completion of this pilot biostudy confirms that we can continue the development of our VersaFilm(TM) tadalafil product,” said Rajiv Khosla, IntelGenx’ President and CEO. “We now plan to progress this project, leading to a pivotal bioequivalence study, with the objective of filing a 505(b)(2) NDA with the U.S. Food and Drug Administration.”
About IntelGenx:
IntelGenx 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’ development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. More information is available about the company at www.intelgenx.com.
SOURCE: IntelGenx
Post Views: 18
SAINT LAURENT, Canada I February 24, 2014 I IntelGenx Corp. (IGX.V) (IGXT) (“IntelGenx”), a Canadian drug delivery company focusing on oral drug delivery, today announced the completion of a pilot biostudy with its proprietary VersaFilm(TM) tadalafil product for erectile dysfunction that indicated bioequivalence with the leading brand reference listed drug (RLD) tadalafil product.
This was a randomized, two-period, two-way crossover study in healthy male subjects. The study was designed to determine whether VersaFilm(TM) tadalafil was bioequivalent as measured by industry standard pharmacokinetic measures of peak plasma concentration (Cmax) and area under the curve (AUC). The study results demonstrated that VersaFilm(TM) tadalafil was within an acceptable range of bioequivalency with the RLD on both of these measures.
“The completion of this pilot biostudy confirms that we can continue the development of our VersaFilm(TM) tadalafil product,” said Rajiv Khosla, IntelGenx’ President and CEO. “We now plan to progress this project, leading to a pivotal bioequivalence study, with the objective of filing a 505(b)(2) NDA with the U.S. Food and Drug Administration.”
About IntelGenx:
IntelGenx 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’ development pipeline includes products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis, oncology and pain, as well as animal health products. More information is available about the company at www.intelgenx.com.
SOURCE: IntelGenx
Post Views: 18
