IntelGenx antidepressant gets FDA nod, but no launch yet
November 11, 2011 — 10:47am ET
By Tracy Staton
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.
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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.
- see the release from IntelGenx
- read the BioMedReports story
- get more from Reuters
Read more: IntelGenx antidepressant gets FDA nod, but no launch yet - FiercePharma http://www.fiercepharma.com/story/intelgenx-antidepressant-gets-fda-nod-no-launch-yet/2011-11-11#ixzz1dQhAJfMu