PF08 Attention-Deficit Hyperactivity Disorder (ADHD)

Market

As many as 4.4 million children in the United States have been diagnosed with ADHD at some point in their lives, and this disorder is also estimated to effect 4.4 percent of U.S. adults between the ages of 18 and 44 years. Psycho-stimulant medications are often prescribed to treat individuals diagnosed with ADHD. In 2003, the CDC reported that 2.5 million patients between the ages of 4 and 17 years (56% of those with a diagnosis) were receiving drug treatment for the disorder. The global ADHD Therapeutics market is projected to reach $4.2 billion by 2015, driven by an expanding patient population and rising diagnosis rates in developed countries.

Unmet Need

While effective treatments for ADHD, stimulants are often abused. Abusing stimulants can increase blood pressure, heart rate, and body temperature, and decrease sleep and appetite, which can lead to malnutrition and its consequences. At high doses, they can lead to serious cardiovascular complications, including stroke. We believe that there is a significant market for an amphetamine that is resistant to abuse.

Signature Therapeutics' Solution

We have applied our Bio-Activated Molecular Delivery™ technology to amphetamine currently prescribed for ADHD. Our novel drugs are expected to substantially prevent abuse via all of the common routes of abuse:

  • Direct injection into the bloodstream
  • Inhalation (snorting or smoking) into the lungs (and then into the bloodstream)
  • Swallowing tablets that have been chewed, crushed, or dissolved
  • Swallowing multiple pills at one time (using our MPAR™ technology)

Our Bio-Activated Molecular Delivery™ (also referred to as Bio-MD™) opioid systems have provided critical human proof-of-concept for the essentially identical technology used for our Bio-MD amphetamine systems. Our amphetamine MPAR technology has been rigorously demonstrated pre-clinically using in vivo models.

Partnering

We expect to enter a worldwide partnership for full development and commercialization of PF08. We may partner this program based on the hPOC of our lead opioid Bio-MD system or after our amphetamine lead is further advanced.