Praxis Wins $1.5M NIH SBIR Grant toward Abuse-Deterrent Prodrug Stimulant

Praxis Bioresearch said today it has won a $1.5 million Fast-Track Small Business Innovation Research (SBIR) grant from the NIH toward ongoing development of the company’s lead product candidate PRX-P4-003, a prodrug stimulant designed to significantly reduce the risk of abuse.

PRX-­P4-­003 is a novel, abuse-deterrent dopamine norepinephrine reuptake inhibitor incorporating an active isomer of fencamfamine (FCF). FCF is a Schedule IV stimulant that has been prescribed for decades in Europe and elsewhere overseas, primarily for depressive daytime fatigue, lack of concentration, and lethargy.

According to Praxis, PRX-­P4-­003 is specifically designed to produce therapeutic stimulant activity when delivered orally—but not if illicitly injected—since PRX-P4-003 is a substrate of pancreatic lipase, an enzyme whose activity is almost entirely restricted to the gut. That minimizes the potential for its oral abuse, the company reasons.

In a study presented at the 2017 Annual Meeting of the American College of Neuropsychopharmacology, ...