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Diclofenac sodium PH. EUR. is the active substance diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).[4] In the product records of the clinical trial listed here, it appears under the product name AMZ001, a gel containing diclofenac sodium at a strength of 3.06%.[1] The substance is classified in the therapeutic area of musculoskeletal diseases.[1] According to the registry data, diclofenac sodium PH. EUR. has no marketing authorisation in the product records, meaning it is an investigational substance in this specific formulation.[1] The authorisation holder for the product is AMZELL B.V.[1]
Diclofenac is an NSAID. When applied to the skin as a gel or spray, it works locally on the affected areas to relieve pain and swelling caused by injury to small and medium-sized joints and the surrounding tissues.[4] The mechanism of action of NSAIDs involves reducing the production of substances in the body that cause inflammation and pain.
In the clinical trial, diclofenac sodium PH. EUR. is given as a gel applied to the skin (topical use).[1] The investigational product AMZ001 is a gel containing 226 mg of diclofenac sodium, applied once daily.[1] Other diclofenac products exist as a 2.32% gel for cutaneous use, which is a licensed medicine in the UK.[3] Diclofenac sodium spray gel 4% is also authorised in the EU as a spray gel applied to the skin.[4]
One completed Phase 3 trial (2024-517404-11-00) has evaluated diclofenac gel AMZ001 3.06% in 540 participants with knee osteoarthritis.[1] The trial was randomised, double-blind, multi-centre, and placebo-controlled.[1] Participants applied the gel once daily to the target knee.[1] The primary endpoint was the change from baseline in the WOMAC pain sub-score (questions 1 to 5) in the target knee, evaluated at week 2.[1] The WOMAC pain sub-score measures pain intensity reported by the patient. The trial also included a matching placebo gel as a comparison arm.[1]
The provided supplementary sources do not list specific side effects for diclofenac gel. Systemic diclofenac products have been associated with cardiovascular risks, which led to risk minimisation measures in the European Union in 2013.[2] A study was conducted to evaluate the impact of these measures on prescribing patterns of diclofenac containing products.[2] No detailed side effect information for the topical gel is available in the provided sources.
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