FDA Guidance leads to additional studies on the effects of drugs on driving

Altasciences Clinical Research
FDA Guidance leads to additional studies on the effects of drugs on driving
Car accident

Since 2013, the Food and Drug Administration (FDA) has been demanding that more and more drugs be tested for their impairing effects, in an effort to improve the design of medication regimens and reduce the incidence of motor vehicle accidents (MVAs) that occur because of drug-impaired driving. With more than 6,800 FDA-approved drugs, many of which contain active psychoactive or sedative pharmaceutical ingredients which could alter the ability to operate a motor vehicle, it is crucial to put in place a systematic effort to identify the drugs that increase the risk of MVAs.

Generating accurate and reliable data for such studies is a challenge for any contract research organization (CRO), but Altasciences has overcome the challenge with a game-changing component they use in the course of these types of complex studies, which include Human Abuse Liability (HAL) assessments.

Our Solution

Altasciences and Cognitive Research Corporation (CRC) have partnered to provide sponsors with a state-of-the-art driving simulator study solution. This simulator allows us to conduct specialized tests in the early stages of clinical development to assess the impairing effects of a wide variety of drugs on driving abilities. It provides accurate driving performance data comparable in sensitivity to over-the-road-testing, but in less time, for less cost, and with no risk of property damage or injuries. Some of its key features include automated measurements, three-dimensional graphics and auditory feedback.

Driving Simulator
Driving Assessment: Flibanserin (Addyi) Case Study

Study Purpose
Altasciences conducted novel endpoint research to determine the extent of next-day impairment of Flibanserin in cognition and alertness.

A randomized, double-blind, placebo-controlled, four-way crossover study was performed to evaluate the potential next-morning residual effects after bedtime dosing in 72 healthy premenopausal women. Treatment arms included a placebo administration group, a positive control zopiclone group, and two separate dosage groups of Flibanserin, which included 100 mg qhs or 200 mg qhs. Assessments were based on simulated driving, a Symbol Digit Coding Test (SDCT), and the Karolinska Sleepiness Scale (KSS).

Bedtime administration of Flibanserin (up to 200 mg) did not impair next-day cognitive function or driving performance, while improving symptoms of HSDD.

Altasciences was able to demonstrate that there was no impairment to driving the morning after nighttime dosing of Flibanserin in premenopausal women. The study was described as “reassuring” by the FDA.

Algorithme Pharma Clinical Research Vince and Associates Clinical Research Algorithme Pharma USA Clinical Research

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