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Johnson & Johnson
Drug Names(s): OROS Methylphenidate HCl, JNS001
Description: Concerta is a central nervous system (CNS) stimulant approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Its active ingredient is methylphenidate and Concerta employs OROS technology, which uses osmotic pressure to deliver medication at a controlled rate. The system, which resembles a conventional tablet in appearance, consists of an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat.
The mode of methylphenidate therapeutic action in ADHD is not known. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. Methylphenidate is a racemic mixture comprised of the d- and l-isomers. The d-isomer is more pharmacologically active than the l-isomer.
Methylphenidate has been used to treat ADHD for more than 30 years, and helps increase attention and decrease impulsiveness and hyperactivity in ADHD patients.
Pink Sheet Concerta Clinical Protocols
Pink Sheet Concerta FDA Reviewers
Pink Sheet Concerta Clinical Development
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