According to information from a new study, an extended-release version of the anti-seizure drug Topamax, is showing good signs of being able to tolerate pharmacokinetics. This data was collected from a recent phase-I clinical trial that looked for just that.
The version of Topamax (USL255), was created by Upsher-Smith Labs, a specialty pharmaceutical company, as a means of providing Topamax in a once-daily dose as a treatment for epilepsy in adults, but also in controlling blood plasma level fluctuations in the blood stream. The first trial was an “open-label, five-way crossover study involving 30 patients who were given a range of doses of USL255, from 25 to 400mg.” The second trial involved 40 participants, who were given “600, 800, 1,000, 1,200 or 1,400mg of USL255, or a placebo.”
What the researchers learned was that the Topamax was able to achieve consistent levels throughout the bloodstream, and that didn’t change among the different participants. All of the doses were also well tolerated as far as the results that were presented at the International Epilepsy Congress in Canada (June 23rd to 27th) showed.
Of the study results, Dr James Cloyd, a professor in the University of Minnesota’s department of experimental and clinical pharmacology, said: “Maintenance of stable antiepileptic drug plasma concentrations to prevent seizures is an important consideration in the management of patients with epilepsy. Second-generation, extended-release antiepileptic drug formulations aim to reduce the frequency of dosing, thereby increasing patient compliance, while at the same time lowering the risk of adverse events related to peak drug concentrations.”
Topamax is a common drug used to prevent seizures, but it is also dangerous to use for women who are pregnant or thinking of becoming pregnant. Topamax has been linked to an increased risk of suicide and suicidal thoughts, and birth defects in women whose babies are exposed to the drug in-utero. Some of those birth defects linked to Topamax use during pregnancy include: cleft lips, cleft palates, genital defects and other birth malformations.
If your baby was born with birth defects after in-utero exposure to Topamax, contact attorney 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.