INDIANAPOLIS (AP) – Eli Lilly and Co. on Wednesday said regulators may require more study of an experimental treatment for attention deficit hyperactivity disorder before it can be marketed. However, Indianapolis-based Lilly said it had received an “approvable letter” from the U.S. Food and Drug Administration, which usually indicates the FDA is prepared to approve a drug but only once certain conditions are met.
Lilly said it hoped to introduce Strattera next spring, but at least one analyst said that might be overly optimistic. Approval hinges on discussions on the drug’s label and submission of additional data or analyses from either existing studies or a potential new study, Lilly said. Unlike Ritalin and other drugs to treat ADHD, Strattera is not a stimulant – a factor Lilly hopes will make the medication more convenient to pick up from pharmacies.
Because stimulants carry potential for abuse, pharmacies require written prescriptions and do not allow refills. Lilly spokesman David Shaffer and FDA spokeswoman Laura Bradbard both declined to comment on the agency’s clinical concerns. An industry analyst said Lilly may be too optimistic in its timeline for the drug, given that a new study may be required. “Almost certainly it is going to cause a delay,” said Hemant K. Shah, an independent analyst from Warren, N.J. “It’s a little surprising that the FDA is asking for this.”Strattera’s market potential is large at a time when Lilly needs a new drug to offset recent setbacks, Shah said. Those include last summer’s loss of patent protection for the anti-depressant Prozac, Lilly’s former best-seller, and manufacturing problems at Lilly plants in Indianapolis that could delay approvals of three other new drugs.
Lilly’s Shaffer said Strattera will be produced at plants in Ireland and Puerto Rico, so its approval will not hinge on the success of Lilly’s efforts to resolve the FDA’s concerns in Indianapolis. Lilly shares rose 4 percent on Wednesday, closing up $2.28 to $58.24 on the New York Stock Exchange.
While many associate ADHD only with children, the condition exists in about 4 percent of adults, said Dr. Leonard Adler, a clinical psychiatrist at New York University who conducted an adult study of Strattera and has received research grants from Lilly. Symptoms include short attention span, impulsive behavior and difficulty focusing and sitting still. Strattera works by blocking reabsorption of a neurotransmitter that moves messages between brain cells. “The studies so far have shown the medicine to be very well-tolerated, and side effects are limited,” including a slight increase in a patient’s blood pressure and pulse, Adler said.
