AVK 001

Avekshan is developing AVK 001, a Fixed Dose Combination (FDC) of methylphenidate [MPH] hydrochloride and naltrexone [NTX] hydrochloride for the treatment of ADHD.

MPH (the same active ingredient in Ritalin®, Concerta® among others) is a central nervous system (CNS) stimulant indicated as an integral part of a total treatment program (typically including other psychological, educational, and social remedial measures) for a stabilizing effect in children and adults with attention deficit hyperactivity disorder(ADHD).

Naltrexone hydrochloride is an opioid antagonist that markedly or completely, though reversibly, blocks the subjective effects of intravenously administered opioids. It is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. 

AVK-001 program is pursuing the 505(b)(2) registration pathway, which has the potential for a relatively rapid development and regulatory timeline.

Why AVK 001?

Methylphenidate (MPH) is among the most commonly prescribed stimulants for treatment of ADHD in children and adults. The abuse of MPH, as a Schedule II controlled substance under the Controlled Substances Act, is a well-documented problem. Other substances such as amphetamine and cocaine included in thisSchedule carry a high potential for abuse, which may lead to severe psychological or physical dependence.

Moreover, there is a relationship between substance abuse and ADHD. The prevalence of adult ADHD in patients with substance use disorder (SUD) is high(23.3%) and, approximately one-fifth of patients at SUD treatment centers may also require treatment for ADHD. A dilemma confronting clinicians is the advisability of prescribing psycho stimulants (i.e., MPH) to adolescents and adults known to be substance abusers, who have comorbid ADHD.  AVK-001could uniquely address this dilemma.

AVK-001 can be the go-to treatment in many other circumstances where ADHD is presented with suspected or active substance use disorder or in cases where risk for substance use or diversion of controlled substances is considered tobe very high whether at home, at work or at school. Finally, AVK-001 can put the patients’ and parents’ minds at ease.

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