[September 05, 2010] IntelGenx reports positive results from erectile dysfunction study Tweet Sep 05, 2010 (Datamonitor via COMTEX) -- IntelGenx, a drug delivery company, has announced the completion of a pilot study that indicates that IntelGenx has successfully developed a novel oral film, INT007, that is bioequivalent to a branded tablet containing a phosphodiesterase type 5 (PDE-5) inhibitor for the treatment of erectile dysfunction. 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 branded PDE-5 inhibitor tablet as measured by industry standard pharmacokinetic measures, peak plasma concentration and area under the curve. 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's INT007 film achieved Tmax 27% quicker than the oral tablet formulation, indicating a potentially faster onset of action. 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) filing. Horst Zerbe, president and CEO of IntelGenx, said: "The achievement of bioequivalence in this pilot study solidifies IntelGenx's position at the forefront of immediate release film development. 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." http://www.datamonitor.com Republication or redistribution, including by framing or similar means, is expressly prohibited without prior written consent. Datamonitor shall not be liable for errors or delays in the content, or for any actions taken in reliance thereon [ Back To TMCnet.com's Homepage ]