Drugs like opioids for treatment of pain and stimulants for treatment of attention deficit hyperactivity disorder (ADHD) might be abused in virtue of their addictive activities on the nervous system. For example, chronic use of opioids leads to dependence, increased tolerance and a psycho-physiological withdrawal state when drug use is stopped or reduced. Stimulants are abused in order to suppress appetite, increase wakefulness, focus and attention.
The American Food and Drug Administration is getting more and more concerned about drug abuse and is applying strict guidance for opioids and pain killers, which are now required to have abuse deterrent formulations (ADFs), and encouraging use of ADFs for any kind of “potentially addictive” drugs. ADFs may act at different levels, either by avoiding drug administration via an unconventional route (for example an injection instead of a pill) or by blocking the rewarding effects induced by overdose or overuse.
We have elaborated 4P-003 an innovative, proprietary ADF developed under the 505(b)(2) approval pathway, aimed at preventing stimulant misuse. Our ADF combine 2 deterrent mechanisms: a class-drug specific effect, by diminishing the stimulant effect (negative feedback: antagonist-like); and a generic pharmacological effect, by inducing a discomfort event.