The United States Food and Drug Administration (FDA) has approved United Kingdom-based GlaxoSmithKline's (LSE/NYSE: GSK) Voltaren Arthritis Pain (diclofenac sodium topical gel, one percent nonsteroidal anti-inflammatory (NSAID)- arthritis pain reliever) as an over-the-counter (OTC) product for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults who are 18 years and older, it was reported on Monday.

With the FDA's approval, the product becomes the first and only prescription strength, NSAID topical gel for arthritis pain available OTC in the United States, where it is presently offered with a prescription. The approval is intended to provide around 30 million Americans with osteoarthritis (OA) over-the-counter access to this topical treatment option.

The submission was based on clinical data in hand and knee OA supporting the original prescription approval. The data demonstrated a consistent and appreciable onset of pain relief beginning as early as week 1 (as evidenced by appreciable improvements in pain symptoms across multiple pre-specified endpoints).