FDA RECOMMENDS SCHEDULE II CLASSIFICATION FOR NEW ADHD DRUG

The FDA issued an approvable letter for New River Pharmaceuticals' and Shire Pharmaceuticals' attention-deficit/hyperactivity disorder (ADHD) drug NRP104, but without the initial classification some analysts believed would give it a significant edge over competitors.

The FDA did not request any additional studies for the drug, but it is withholding final approval pending a scheduling decision by the Drug Enforcement Administration (DEA), which regulates controlled substances based on their potential level for abuse. The FDA recommended that NRP104 receive a Schedule II classification, which is used for drugs, like amphetamines, that are approved for medical use but have the highest potential for abuse.

Study data released in June 2006 showed that NRP104 was less likely to be abused than other ADHD drugs, including Adderall XR, the world's most-prescribed ADHD drug. Merrill Lynch analyst David Munno wrote at the time that the results should convince the FDA to classify NRP104 as a Schedule III or IV drug. Either of those classifications would have given NRP104 a considerable advantage over other ADHD drugs, Munno noted.

If the DEA agrees that NRP104 should be rated as a Schedule II controlled substance, analysts say that the labeling for the drug will be key for marketing. Since NRP104 and Adderall XR would share the same schedule rating, NRP104's labeling may include data promoting its lower abuse potential to convince patients to switch.

New River and Shire say they intend to launch NRP104 in the second quarter of 2007.