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news.IntelGenx has completed a pilot study which indicates that the company has successfully developed a novel oral film, INT0022, which is bioequivalent to a leading branded anti-psychotic.
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INT0022 has been developed using IntelGenx’ proprietary immediate release ‘VersaFilm’ drug delivery technology
The randomised, two-period, two-way crossover study in healthy male subjects was designed to evaluate whether INT0022 is bioequivalent to an anti-psychotic product, as measured by peak plasma concentration (Cmax) and area under the curve (AUC).
The study results demonstrate that INT0022 falls within the range of bioequivalency for both Cmax and AUC.
Following the successful completion of the study, the company is planning to initiate scale-up and manufacturing of the batches required to support a pivotal clinical study and a future regulatory 505(b)(2) filing.
IntelGenx president and CEO Horst Zerbe said that oral thin films could offer some unique advantages over conventional methods of medication, especially in patients with anti-psychotic behavioural symptoms where patient compliance is an issue.
"Furthermore, our thin films are engineered to reduce drug exposure in the gastrointestinal tract, which could be a substantial benefit in minimising certain GI related side effects associated with anti-psychotic medicines," Zerbe added.