Parkinson’s disease is a chronic, progressive neurodegenerative disease that causes deterioration of motor function, as well as many non-motor complications throughout the various stages of the disease. As nearly a million people in the United States suffer from Parkinson’s disease, with 1100 people aged over 60 hit .These results and other program USL255 early stages of development were presented Sunday, December 5th to the 64th Annual American Epilepsy Society meeting in San Antonio, TX. USL255, developed by Upsher-Smith Laboratories, Inc., and is now the subject of a Phase III clinical world, is designed to provide an easy once-daily dosing with smoother topiramate plasma levels than traditional IR dosage forms.
Epilepsy is a medical condition that produces seizures involve a variety of mental and physical functions. Nearly three million people in the United States have some form of epilepsy, with about 200,000 new cases of epilepsy are diagnosed each year .
In a related development, Upsher-Smith recently announced the addition of an open-label extension of its global Phase III clinical study for USL255. The phase III clinical trial was conducted at a Special Protocol Assessment agreement with the Food and Drug Administration .
- ‘Development and optimization of sustained-release formulations of topiramate.’ Authors: Lawrence J. Lambrecht, Mark B. Halvorsen, Michael J. Boulware, Wesley M. Todd, John A
In the third displays the data in the same study compared two doses of 100 mg IR topiramate and a single dose of 200 mg of USL255 pharmacokinetic equivalence, using standard bioequivalence criteria. The authors reported that administration of 200 mg of USL255 in healthy volunteers provided equivalent exposure of topiramate compared with topiramate 100 mg administered twice daily IR. USL255 also showed a lower maximum plasma concentration of topiramate IR.
‘Fluctuation in plasma levels of certain anti-epileptic drugs is thought to have the potential to contribute to increased side effects for patients at the peak concentrations or’ breakthrough ‘seizures at trough concentrations just before the next dose. Therefore, a formulation of topiramate may offer reduced fluctuations in plasma is of interest to many clinicians, ‘said Mark Halvorsen, Pharm., Senior Director, Clinical Development.
The studies that are the subjects of these posters were made by Upsher-Smith to characterize the pharmacokinetic profile of USL255. The first poster presents data from a variety of internally developed topiramate ER formulations. The aim of the research presented was to identify a once-daily ER formulation with a lower maximum plasma concentration, a higher concentration quarry, and, in an equivalent exposure compared to IR topiramate. The pharmacokinetic data from experimental formulations were compared with IR topiramate, after a single dose and / or to simulate the steady state. The results helped the researchers in the selection of formulation USL USL255
‘We are excited about the progress we made in our development of USL255 and encouraged that USL255 may offer an improved pharmacokinetic profile compared to IR topiramate,’ Halvorsen said. ‘We are engaged in the development of USL255 for patients with refractory partial seizures with as part of USL’s ongoing commitment to become a leader in providing therapies that help people with diseases of the CNS to lead a healthy and productive life.’
USL255 is the main drug Upsher-Smith experimental expansion of the central nervous system development pipeline, with an initial indication for adjuvant treatment of adult epilepsy patients with partial onset seizures . Another program of this pipeline, USL261 was developed for the management of episodes of increased seizure activity, including acute repetitive seizure of epilepsy groups. Other programs include USL260 , an experimental drug and the first class of neuronal gap junction modulator for the potential treatment of epilepsy. Upsher-Smith has already announced its partnership with Proximagen Group Plc for PRX1 program for the symptomatic treatment, in which Upsher-Smith is responsible for the development and worldwide marketing of PRX1 under the direction of the spouse of a Steering Committee which is the representation of both Upsher-Smith and Proximagen.
‘ Authors: Wesley M. Todd, Lawrence J. Lambrecht, Michael J. Boulware, Mark B. Halvorsen