On March 12, 2012, Upsher-Smith Laboratories showed data from a Phase I pharmacokinetic study which analyzed profiles from 10 one-a-day extended release versions of Topamax, all of which were created at Upsher-Smith Labs. This information was presented at American Pharmacists Associations’ (APhA) 2012 Annual Meeting in New Orleans.
Out of all of the formulations that the trial monitored, at least one version of the extended release Topamax tablets was considered a viable candidate for further development. That particular formulation was green-lighted because it met with all of the pre-established single-dose goals set up for comparison to the immediate-release versions of Topamax. The pills were tested on various healthy people who volunteered for the study. Information about the trial can be found here.
The Senior Director of Clinical Development at Upsher-Smith, Mark Halvorsen, said, “With the identification of an optimal formulation of extended-release topiramate, we hope to reduce the blood level fluctuations that can occur when taking immediate-release topiramate and that may be associated with adverse events at peak levels and break-through seizures at trough levels.”
Topamax, which is used to treat epilepsy, has been linked to various adverse side effects including birth defects. Some of the birth defects linked to Topamax include PPHN, oral clefts, cleft palate, neural tube defects and heart, lung and brain defects. Most recently, Topamax has been under fire for being the main ingredient in a new weight loss medication — Qnexa — that has been approved by an FDA panel. With so much working against Topamax, it is a wonder that newer versions would be in the works.
If your baby was born with any of the birth defects linked to Topamax after being exposed to the drug in-utero, contact the attorneys at Greg Jones today for a free consultation. I am experienced at fighting Topamax lawsuits and may be able to help you recover money for your child’s injuries.