IntelGenx antidepressant gets FDA nod, but no launch yet

IntelGenx Technologies has FDA approval in hand for its high-dose antidepressant. Now what? For now, not much. The company can't launch the drug--still known by its CPI-300 code name--until it has a marketing partner. And that isn't expected to happen till the second quarter of next year.

The product is a formulation of Bupropion hydrochloride, the active ingredient in Wellbutrin XL, that allows a 450 mg dose in a single tablet. Biovail, which markets Wellbutrin, only sells 300 mg and 150 mg pills. It has tried to develop a 450 mg version, but hasn't succeeded. Biovail also tried to thwart IntelGenx's efforts with a patent suit, but the smaller company won that fight.

About 10% of Wellbutrin XL prescriptions are for a 450 mg daily dose, IntelGenx CEO Horst Zerbe told BioMed Reports, which requires patients to take two different-strength pills, creating the potential for compliance problems and accidental overdosing. "This would increase the risk of a seizure almost tenfold," Zerbe said. IntelGenx has said that there's a $150 million-plus market right now for a 450 mg pill.

The company says it's in "active licensing discussions with several leading generic and specialty pharmaceutical companies." It says it expects a commercialization deal soon. It already has in hand a manufacturing deal with Pillar5 Pharma.

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- read the BioMedReports story

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