ORADUR®-Methylphenidate ER

Overview

ORADUR-Methylphenidate ER is an investigational formulation of methylphenidate being evaluated for its ability to provide once-daily dosing while resisting certain common forms of drug tampering. Methylphenidate, the active ingredient, is approved and widely-prescribed for the treatment of attention deficit hyperactivity disorder (ADHD).

Methylphenidate exposes patients to risks of addiction, abuse, and misuse even when abuse-deterrent properties are present. ORADUR-Methylphenidate ER is an investigational drug and has not been approved by the FDA for marketing in the U.S. for any indication.

ORADUR-Methylphenidate ER is being studied for its ability to:

  • Allow once-daily dosing with a rapid onset of action and small capsule size
  • Deter the most common methods of abuse (snorting, smoking, injecting, chewing, and dissolving in drinks)

Methylphenidate exposes patients to risks of addiction, abuse, and misuse even when abuse-deterrent properties are present. ORADUR-Methylphenidate ER is an investigational product and has not been approved by the FDA for marketing in the U.S. for any indication.

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 prescribed as first-line agents. U.S. sales of ADHD treatments were approximately $10.4 billion in 2016. 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.

ORADUR-Methylphenidate ER is an investigational product and has not been approved by the FDA for marketing in the U.S. for any indication.

Orient Pharma obtained authorization from the Taiwan Ministry of Health and Welfare to market Methydur Sustained Release Capsules in Taiwan in September 2018. Orient Pharma has stated that it expects to have Methydur Sustained Release Capsules commercially available in Taiwan in 2019. Methydur Sustained Release Capsules approved for sale in Taiwan are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and are available in three strengths (22 mg, 33 mg, and 44 mg). Orient Pharma has stated that it is pursuing regulatory approvals in selected other countries and is also seeking a commercial partner in China.

ORADUR-Methylphenidate ER is an investigational product in the U.S. and has not been approved by the FDA for marketing in the U.S. for any indication. Methydur Sustained Release Capsules are not approved for marketing in the U.S. or in any country or territory other than Taiwan.

DURECT has licensed the development and commercialization rights for ORADUR-Methylphenidate ER 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.

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.