Sree Koneru, Ph.D., VP Product Development, said, "The clinical data from all three studies clearly indicates that the ActiPatch treats musculoskeletal pain significantly better in women than men. We have provided a detailed explanation on how our existing data meets the FDA's clinical performance data requirement, and that additional studies are not required. Given the FDA's guidance on gender analysis in clinical studies, precedent for gender-specific approvals and development of least burdensome guidelines, we are looking forward to a favorable outcome of our responses by the FDA."

The ActiPatch product is already FDA-cleared for over-the-counter adjunctive treatment of pain from knee osteoarthritis (25 million Americans) and plantar fasciitis (2 million Americans annually).