Assessing the potential for next-day driving impairment of Flibanserin
Algorithme Pharma is proud to have partnered with Cognitive Research Corporation to evaluate the sedation-related safety of Flibanserin in premenopausal women. A research study sponsored by Sprout Pharmaceuticals.
Since 2013, there has been a noticeable increase in the information provided by the Food and Drug Administration (FDA) on the effects of prescription and over-the-counter medication on driving, such as allergy medications and sleep drugs. More and more, the FDA demands that certain drugs be tested for impaired effects.
It is clear that all new drugs should be evaluated for adverse effects on the Central Nervous System (CNS) during first-in-human (FIH) studies, which is a dramatic change from how most trials are standardly designed today. The ability of Algorithme Pharma to conduct these specialized tests, combined with the highly recognized battery of psychomotor and neurocognitive tests offered by CRC, allow us to seamlessly incorporate these elements into our trials.
Key Features of the Driving Simulator
- Several simulator scenarios have proven to be highly sensitive to both therapeutic and adverse drug effects.
- The simulator utilizes advanced three-dimensional (3D) graphics to generate realistic representations of various driving environments. The visual environment includes the vehicle dashboard, roadway, horizon, secondary task displays, intersections, traffic control devices and interacting traffic.
- Steering sensitivity is adjusted as a function of vehicle speed.
- Auditory feedback is provided for engine speed, acceleration limits, and for indication of excessive cornering speed, or excessive deceleration when braking.
- It provides automated measurements of psychomotor functioning, divided attention, situational awareness and other cognitive behaviors.
- CRC has developed equivalent versions of various driving simulation tasks (scenarios) that allow for re-testing while monitoring practice effects.