Evolving the Treatment of Epilepsy
Epilepsy is a complex neurological disorder, estimated to affect 50 million people worldwide. Current treatment options may be limited by compliance and tolerability issues. Supernus Pharmaceuticals is developing a promising epilepsy product portfolio consisting of:
- SPN-538, which utilizes our proprietary Microtrol® technology
- SPN-804, which utilizes our proprietary Solutrol® technology
The advanced technologies used in these product candidates have been proven and validated through use in currently approved and marketed extended-release products, including Carbatrol® (carbamazepine), Adderall XR® (mixed salts of a single-entity amphetamine product), Intuniv® (guanfacine), Sanctura XR® (trospium chloride), and Oracea® (doxycycline, USP).
SPN-538 (extended-release topiramate)
Our product candidate, SPN-538, is a novel, oral, extended-release, once-daily formulation of topiramate for the treatment of epilepsy. We submitted an NDA to the FDA for SPN-538 in 2011. SPN-538 delivers topiramate, one of the most effective antiepilepsy drugs, which is marketed by Johnson & Johnson under the brand name Topamax®.
Limitations of Topiramate
- Topiramate is currently available only in immediate-release form and is indicated for monotherapy and adjunctive therapy of epilepsy, as well as for the treatment of migraine
- Side effects associated with topiramate, which have tended to limit its use, include dizziness, fatigue, somnolence, and slowing of certain cognitive functions
SPN-538: An Alternative Therapy to Immediate-release Topiramate
Extended-release, once-daily SPN-538 is designed to:
- Improve patient compliance compared to the current immediate-release products that are taken multiple times per day
- Deliver lower peak plasma concentrations and lower input rate over an extended time period, resulting in smoother and more consistent blood levels of topiramate during the day compared to immediate-release Topamax®
- Avoid blood level fluctuations that can be associated with many of the side effects or breakthrough seizures that patients can suffer from when taking immediate-release products
SPN-804 (extended-release oxcarbazepine)
Our second late-stage product candidate, SPN-804, is a novel, oral, once-daily, extended-release formulation of oxcarbazepine. We submitted an NDA to the FDA for SPN-804 in 2011.
- SPN-804 delivers oxcarbazepine, another effective antiepileptic drug, which is marketed by Novartis Pharmaceuticals Corporation under the brand name Trileptal®
- Oxcarbazepine is an active voltage-dependent sodium channel blocker that, despite its effectiveness in treating epilepsy, is associated with many side effects that tend to limit its use, such as dizziness, double vision, somnolence, nausea, and vomiting
- Extended-release, once-daily SPN-804 has been designed to improve patient compliance and to avoid blood level fluctuations that can be associated with many of the side effects or breakthrough seizures that patients can suffer from when taking immediate-release products