Company: NCEL
Filing Date: 2025-06-23
Form Type: F-4/A
Source: 0001213900-25-056787
Chunk: 349

Company: NewcelX Ltd.
Filing Date: 2025-06-23
Form: F-4/A
Chunk 349
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 patient adherence rates and sub -optimalefficacy with the onset of drug tolerance. According to the 2002 practice parameter for the use of stimulant medications from the American Academy of Child & Adolescent Psychiatry, approximately 30% of patients do not respond adequately to or have dose -limitingadverse effects with CII stimulants. Additionally, certain patients, or parents of patients, prefer not to use CII stimulants due to their stigma and known abuse potential. There are a few non -stimulanttreatments available, such as atomoxetine (Strattera ®), clonidine (Kapvay ®), and guanfacine (Intuniv ®), that were developed to address this need; however, their efficacy is sub -optimalto stimulants and while unscheduled, their overall safety profile does not necessarily provide an improvement to CII stimulants. Strattera, a norepinephrine reuptake inhibitor, was the first non -stimulanttreatment option for ADHD and while its initial launch started strong, underscoring the demand for an alternative to CII stimulants, sales steadily declined as patients and physicians found it to not be nearly as effective as CII stimulants. It is now considered a second -linetreatment and is typically used as an alternative to CII stimulants for patients who have a substance abuse problem, a family member(s) with a substance abuse problem, tics, or intolerable side effects with CII stimulants. Strattera carries a Black Box warning for increased risk of suicidal thoughts in children and adolescents and additional warning statements for liver damage. Moreover, Strattera takes four weeks to reach initial onset of action and six to ten weeks to achieve full clinical effectiveness, related both to the prolonged titration needed and the delay in the onset of action of the compound. Today, Strattera (branded and generic version) has about 3.6% market share, despite initially climbing to nearly 20% following launch on the basis of being an alternative to CII stimulants. Clonidine and Guanfacine are also non -stimulantsthat are alpha -2adrenergic receptor agonists and were both initially approved for managing blood pressure. They have been approved for use in children and adolescents, generally in conjunction with CII stimulants as an add -ontherapy. While they are used in children and adolescents, there is little study of their efficacy and