Shire Overstates Benefits of Attention Deficit Drug Intuniv, U.S. FDA Says

Shire Plc overstates the benefits of Intuniv, its drug for attention deficit hyperactivity disorder in children, in promotional materials, U.S. regulators said.

Brochures in a patient starter kit for the drug make “unsubstantiated effectiveness claims” and “omit and minimize important risk information,” the Food and Drug Administration said in a June 22 letter to the company posted today on the agency’s website.

Shire won FDA approval in September to sell the once-daily extended-release tablets to treat the attention disorder in children and adolescents. The Dublin-based company has been betting on Intuniv and Vyvanse, the successor to Shire’s Adderall treatment for hyperactivity, to counter losses after generic versions of Adderall reached the market in April. Intuniv, whose chemical name is guanfacine hydrochloride, brought in $5.4 million in sales last year, Shire said in a statement.

Clinical studies don’t support the company’s claims that the drug improves “individual behavioral problems” such as “bedtime blowups,” “homework hassles” and “mall meltdowns,” the FDA said.

The promotional materials cited in the agency’s letter have been “removed from the field,” Matt Cabrey, a U.S. spokesman for Shire, said today in a telephone interview.

“This is something we take very seriously, and we are now reviewing the information and working closely with the FDA in order to update the materials with the correct information,” Cabrey said.

To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net

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