FDA approves high dose anti-depressant
The FDA has approved IntelGenx' lead product, CPI-300, for patients with Major Depressive Disorder. CPI-300 is a novel, high-strength formulation of Bupropion hydrochloride (HCl), the active ingredient in Wellbutrin XL. CPI-300 is the only single dose 450 mg formulation of Bupropion HCl approved by the FDA.
"This is a defining moment for IntelGenx, as we have now clearly demonstrated our ability to independently take a product through development to regulatory approval," said Dr. Horst G. Zerbe, president and chief executive officer of IntelGenx. "We believe physicians will embrace CPI-300 as a more convenient and safe alternative for their patients requiring high-dose anti-depressant therapy. So we now turn our focus towards the commercialization of CPI-300, with the objective of a product launch with a partner by the second quarter of 2012."
IntelGenx has been in active licensing discussions with several leading generic and specialty pharmaceutical companies and anticipates finalizing a commercialization agreement soon. As previously announced, the company has entered into an agreement with Pillar5 Pharma for the commercial manufacturing of the product.