The November issue of NeuroPerspective features our first full review of this major disorder since 2011. Epilepsy affects approximately 1% of the population, which translates into three million people in the United States with an epileptic disorder, and 125,000 new cases diagnosed each year: 3-5% of all individuals will have an epileptiform ‘event’ during their lifetime. The sales of anticonvulsant drugs exceeds $2 billion annually in the United States alone, more than $3.5 billion worldwide. The bill has begun to climb as new proprietary drugs have supplemented the armamentarium of the generic old guard, albeit with barely-perceptible improvements in overall efficacy and modestly better adverse event profiles. One tangible strategic shift is that, rather targeting a broad spectrum of patients, new drugs are aimed at very small pediatric populations, such as West and Dravet Syndromes, or patients in acute crisis states, like Acute Repetitive Seizures and Status Epilepticus. The key bottom line is that up to one-third of patients with epilepsy still do not achieve adequate seizure control.
For the time being, the window of opportunity exists primarily for a slowly shrinking (as the range of options increases) pool of highly treatment-refractory patients. These niche markets are primarily being pursued by small to midsize companies, particularly since they are accessible to a highly targeted specialty sales force. But a new therapeutic that is effective with treatment-refractory epilepsy; a more tolerable monotherapy; or an adjunct which permits dose-sparing of problematic primary drugs; could be utilized by a wide swathe of the patient population. Any of these developments could begin to usher epilepsy back on to the radar screens of larger pharmaceutical companies with an ongoing interest in neurology.
Eventually, unraveling the sequence of events that set the stage for epilepsy will foster pre-emptive therapies, throttling epileptogenesis rather than trying to corral its convulsive offspring. Just as prophylaxis via CGRP antibodies has rekindled migraine interest in some large companies who had wearied of the oral triptan traffic jam, when a disease-modifying anti-epilepsy agent emerges that is thereby differentiated from its predecessors, that will transform the drug development and licensing environment for epilepsy.Read More