ORADUR®-Methylphenidate

Overview

Methylphenidate is a drug approved and widely prescribed to treat attention deficit hyperactivity disorder (ADHD). ORADUR-Methylphenidate is a once-daily tamper-resistant formulation of the widely-prescribed ADHD medication methylphenidate. (Methylphenidate is classified in the U.S. as a Schedule II controlled substance.)

  • Rapid onset of action
  • Small capsule size
  • Proprietary formulation incorporating several properties that deter abuse by the most common methods (snorting, smoking, injecting, chewing, and dissolving in drinks)

Attention deficit hyperactivity disorder (ADHD) is a neurobehavioral condition estimated to affect over 5 million (approximately 9%) of U.S. children ages 3-17, according to the U.S. Department of Health and Human Services. The principal characteristics of ADHD are inattention, hyperactivity, and impulsivity. The condition typically manifests during childhood, and many patients continue to be affected as adults. Over 50% of children with ADHD are medically treated, with stimulants such as amphetamine and methylphenidate commonly used as first-line treatment. U.S. sales of ADHD treatments were approximately $9 billion in 2014. The 2010 National Survey on Drug Use and Health estimates that 1.1 million Americans over the age of 12 abuse stimulants for euphoric highs and increased performance or wakefulness.

Orient Pharma has initiated a Phase 3 study in Taiwan and anticipates completing it in 2016.

DURECT has licensed the development and commercialization rights for ORADUR-Methylphenidate to Orient Pharma Co., Ltd. (Orient Pharma) for certain defined Asian and South Pacific countries. DURECT retains rights to North America, Europe, Japan, and all other countries not specifically licensed to Orient Pharma. For a description of the associated terms, please see Collaborations.

Learn more about ORADUR abuse-deterrent technology

There are risks and uncertainties associated with our business. Please see our most recent SEC filings (10-K or 10-Q) for a complete description of these risks and uncertainties, which are incorporated herein by reference.