- FDA reviewers support efficacy of Forest Labs' IV antimicrobial ceftaroline for treating pneumonia, complicated skin and skin structure infections
- FDA updates label for Pfizer's Tygacil to warn of increased mortality risk
- FDA approves Abbott's HBV molecular diagnostic for measuring viral load
- FDA approves new version of Allergan's Lumigan
- FDA approves Reckitt Benckiser's Suboxone sublingual film for treatment of opioid dependence
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
- Pediatric subspecialty telephone consultations may be cost-saving for Medicaid, research reveals
- Use of mental health services greater in health plans with parity in cost sharing, data find
- Public opinions appear split on health care affordability, satisfaction, survey finds
- In Brief: California Supreme Court
IntelGenx receives complete response letter for investigational antidepressant
Monday, February 08 2010 | Comments
What's This?
The Food and Drug Administration sent a complete response letter to IntelGenx Corp. regarding CPI-300, a new, high-strength formulation of bupropion hydrochloride the firm is developing with Cary Pharmaceuticals Inc. for the treatment of major depressive disorder (MDD).The FDA is requesting that IntelGenx address the qualification of its commercial manufacturing site and provide further information on the food effect observed with CPI-300 in the food-effect study submitted as part of the New Drug Application (NDA) for the product.
"There were no surprises for us in the letter, as we had alerted [the] FDA to the manufacturing issue ourselves and have been aware of the agency's sensitivity toward the food effect, which is being observed in all bupropion extended-release products," said Horst Zerbe, chief executive officer of IntelGenx. "That has allowed us to proactively manage the situation and stay on course for a possible late-2010 FDA approval."
The company said it has already identified a new contract manufacturing organization and has started generating the data it needs to support an amendment to the NDA.
With regard to the food effect of CPI-300, IntelGenx believes this issue can be resolved through a label adjustment and "a thorough postapproval educational effort."
The firm plans to meet with the FDA to clarify what is necessary to obtain approval of CPI-300.
IntelGenx entered into a collaborative agreement with Cary Pharmaceuticals in 2007 to develop CPI-300 using IntelGenx's controlled-release oral delivery technology. Under the terms of the agreement, IntelGenx raised $2 million to fund completion of the product's development. The two companies will share the profits of the drug upon commercialization.
Comments
Be the first to write a comment for this article!
You must be logged in to post a comment.
- White blood cell count in presence of elevated ESR, CRP level predicts infection status in patients undergoing total hip arthroplasty, researchers report
- AISRS useful in measuring methylphenidate therapy for adults with ADHD
- Adalimumab improves peripheral arthritis, enthesitis, axial signs, symptoms of AS in patients with long-standing disease treated in real-life practice, researchers report
- High levels of hemoglobin A1C appear to increase risk of complications following CABG
- Radiotherapy, chemotherapy increase risks of second malignancy, cardiovascular disease similar to smoking in patients with testicular cancer, researchers report
- School-based nutrition, exercise intervention program may not maintain BMI decreases through 10 months in overweight students, data indicate
- Careful discharge planning, follow-up vital for high-risk neonates facing hospital discharge, updated AAP guidelines state
- MTA Cooperative Group uses 8-year MTA follow-up data to assess long-term outcomes in children with ADHD
- Radiotherapy, chemotherapy increase risks of second malignancy, cardiovascular disease similar to smoking in patients with testicular cancer, researchers report
- Lipid-modifying drugs may decrease all-cause, cardiovascular-specific mortality in patients on peritoneal dialysis, study data suggest
