Lamotrigine is a commonly prescribed antiepileptic drug (10 million prescriptions in 2012), and is also approved for bipolar disorders. CURx would have the only IV/Oral formulation, should our product be approved. CURx would likely have orphan designation and the clinical development plan would follow a 505(b)(2) clinical development plan to regulatory filing. Captisol solubilizes, stabilizes and overcomes the bitter taste of Lamotrigine. The formulation has the potential of a more rapid onset of action, is clinic ready and is a strategic fit with the CURx pipeline.
Stable-labeled IV LTG has been administered to 20 persons with epilepsy (6 men; 14 women).