IRVINE, Calif. (AP) — The FDA wants more information about Botox before approving it to treat spasticity of the upper limbs, said the drug’s maker, Allergan Inc. Allergan said Tuesday it received a “complete response letter” from the FDA. Last fall, the company asked the agency to approve Botox as a treatment for spasticity of the upper limbs in adults who have suffered a stroke. The FDA did not ask Allergan to run new clinical trials, a process that would take months or years, but it did request more safety information, and details from a previous trial. It also suggested a broader label for the drug, allowing Botox as a treatment for spasticity regardless of cause, not just stroke. The FDA recommended that Allergan could conduct a post-approval study of Botox for upper limb spasticity in patients age 2 to 17 in addition to adults. Botox is the refined form of a toxin that causes botulism. It is currently approved as an anti-wrinkle drug. The FDA requested a risk evaluation and mitigation strategy for Botox, and a safety update from all studies of the injection. It also wants Allergan to verify data related to a clinical study performed in 1999, and asked for an updated analysis of that data. Allergan said it believes it can submit the data in 60 to 90 days.
