• Most long-acting stimulant products currently on the market do not remain effective for more than 8-12 h after administration, and many patients do not experience clinical efficacy beyond 6-8 h1. It is estimated through clinical observation that this results in approximately 50%-60% of college students and
adults having to take a third IR dose in the evening, which can lead to unfavorable side effects such as loss of appetite (for dinner) and insomnia.
• As blood levels drop precipitously during the latter portions of the day, some
patients may also experience a rebound effect, which often manifests in adverse
events such as irritability, mood changes and worsening of clinical presentations.
Commonly known as the “afternoon crash”, these undesirable effects are the
result of a rapid reduction in plasma levels of d-MPH in school age children
approximately 7-8 h post-administration, interfering with the end of the school day,
after-school activities, and completion of homework.
• CTx -1301 is a novel tri-modal d-MPH tablet formulation, developed in conjunction
with BDD Pharma utilizing proprietary OralogiK® delayed release technology. It
comprises an immediate release layer, a delayed sustained-release layer, and a
final immediate-release core. This is designed to provide a fast onset, and
ultimately therapeutically active levels of d-MPH lasting up to 16 h.
• The preparation is designed to extend duration, provide a controlled descent of
d-MPH to minimize the rebound effect, and maintain favorable tolerability.
• In this presentation, we describe how the third delayed dose from the core
performed in terms of where it is delivered in the gut, and how this precision timed
release technology achieves a controlled descent. Additional results have been