Supernus is focused on developing and commercializing products for the treatment of central nervous system, or CNS, diseases. The company's lead products, Oxtellar XRTM and Trokendi XRTM are for the treatment of epilepsy. Supernus is also developing product candidates to address large market opportunities in attention deficit hyperactivity disorder, or ADHD, including ADHD with impulsive aggression.
Supernus has two products for the treatment of epilepsy. Supernus plans to launch Oxtellar XRTM in the first quarter of 2013 and Trokendi XRTM after it receives final approval by the FDA, in the third quarter of 2013.
Oxtellar XRTM is a novel, oral, once-daily, extended-release formulation of oxcarbazepine. We received FDA approval in October 2012.
Oxtellar XRTM 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
Trokendi XRTM, is a novel, oral, extended-release, once-daily formulation of topiramate for the treatment of epilepsy. We received tentative approval from the FDA in June 2012. Trokendi XRTM delivers topiramate, one of the most effective antiepilepsy drugs, which is marketed by Johnson & Johnson under the brand name Topamax®.
Topiramate as an anti-epileptic drug 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
Oxtellar XRTM and Trokendi XRTM are 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 oxcarbazepine or topiramate during the day compared to immediate-release products
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
Build in-house sales and marketing capabilities, focused on specialty markets in the United States, to launch Oxtellar XRTM and Trokendi XRTM.
Continue to advance our product candidates in our psychiatry portfolio, including SPN-810 and SPN-812. As part of our longer-term strategy, we intend to continue to develop our product candidates in our psychiatry portfolio to enable further diversification of our pipeline and future growth.
Develop differentiated products by applying our technologies to known drug compounds.
Establish strategic partnerships to accelerate and maximize the potential of our product candidates worldwide.
Leverage our management team's expertise to develop and commercialize our broad portfolio of product candidates.
Supernus was founded in 2005 following the acquisition of substantially all of the assets of Shire Laboratories Inc. in late 2005. The company previously had been a U.S. subsidiary of Shire plc. Supernus and its management team have more than 20 years of experience in developing and commercializing CNS products.