CINCINNATI, Ohio—P2D Bioscience, acentral nervous system (CNS)-focused specialty pharma, has teamed upwith Bangalore, India-based Advinus Therapeutics Ltd. to research,develop and market a new class of drugs "not subject to abuse" totreat attention deficit hyperactivity disorder (ADHD), the mostcommonly diagnosed psychiatric disorder in children.
This disorder has been steadily risingin the United States. In the 1970s, 12 per 1,000 children werediagnosed with ADHD, compared to 34 per 1,000 in the 1990s.Statistics from the National Institute of Mental Health (NIMH) reportthat 3 to 5 percent of the U.S. population has been diagnosed withADHD—including 4.7 percent of American adults.
Scientists are not sure what causesADHD, although many studies suggest that genes play a large role.Most experts believe ADHD probably results from a combination ofgenetic and environmental factors such as nutrition, brain injuriesor social environment.
The dramatic increase in ADHD,manifested by difficulty staying focused and paying attention,controlling behavior and hyperactivity has been accompanied by a risein medication, particularly stimulants such as methylphenidate (e.g.,Ritalin) and amphetamines (e.g., Adderall).
Stimulant medications work well tocontrol ADHD symptoms, but they are only one method of treatment forthe condition. However, experts estimate that about 60 percent ofchildren with ADHD are treated with medication, according to Dr.Benedetto Vitiello of the NIMH and a co-author of the study.
Further, current ADHD medications havesignificant side effects. To counteract these effects, P2D andAdvinus are co-developing a new class of ADHD treatments, says Dr.Rashmi Barbhaiya, CEO of Advinus. These drugs demonstrate increasedefficacy due to their higher affinity for the target receptor, aswell as improved safety due to enhanced selectivity.
"Academic institutions and theirspinoff biotech companies are beginning to play increasinglyimportant roles in discovering innovative drug candidates, and at thesame time, continue to depend on partners to develop these assets,"Barbhaiya stated in a news release. "The P2D ADHD program is aclassical example of the value Advinus provides to such institutionsand benefits it derives from such collaborations."
Dr. Frank Zemlan, CEO and chairman ofP2D Bioscience, says, "Advinus was identified by our Indian-basedteam as the premier preclinical and early-stage clinical developmentcompany in southeast Asia. P2D partnered with Advinus because oftheir drug development expertise and experience. We are developing asingle drug for ADHD that is owned by P2D, and we will be taking itto market. Advinus' role is to do the preclinical safety andtoxicology studies that will allow us to take it to the FDA todetermine if it is safe and effective for humans. Advinus' studieswill help us get the drug to the point where we test it in humans,and hopefully, take it to market."
With the rise in ADHD, "there is ademand for more effective drugs for treating ADHD," Zemlan notes.Yet he adds, "There is a definitive need for a first-line ADHD drugthat is not scheduled or subject to abuse—and our drug will fillthat need."
The prescribed use of stimulantmedications to treat ADHD rose slowly but steadily from 1996 to 2008,according to a study conducted by the U.S. National Institutes ofHealth (NIH) that was published in September 2011 in the AmericanJournal of Psychiatry.
During the 1990s, stimulantprescription use increased significantly, going from a prevalencerate among youth of 0.6 percent in 1987 to 2.7 percent in 1997, withthe rate stabilizing around 2.9 percent in 2002, according to theNIH.
"First-line treatments for ADHD areall scheduled to drugs for abuse, as defined by the FDA and DEA,"he says. "In other words, if someone were to give his/her ADHDdrugs to a friend, he/she could be prosecuted for a felony. P2D'sdrug is not scheduled to drug for abuse. There is no abuse potential,which means there is not any abuse liability, abuse potential orlegal liability if they were to pass it on to someone else."
