Beginning in 2007 the FDA approved three medications for fibromyalgia, Lyrica, Cymbalta and Savella. Several other medications were either ready to be submitted to the FDA for approval or in various stages of clinical trials, but were either not approved or shelved by the developing pharmaceutical companies. Since early 2009, when the last drug, Savella, was approved, new FM medication development seems to have fallen by the wayside. The NFMCPA recently began the process of tracking down any new information concerning medications in order to update our constituents about possible scientific trials and new directions in fibromyalgia drug development.
It appears that there are currently two promising medications in various research phases: Effirma, being developed by Synthetic Biologics, and TNX-102 a Product of TONIX. Each of these medications is unique and their mechanisms of action (how they work) radically different.
Effirma, or flupertine as it is known in Europe and other international countries, is an analgesic pain-relieving drug that cannot be described as an opioid, a steroid, or a non-steroidal anti-inflammatory (NSAID) in contrast to other available analgesics. It has been used in Italy, Germany, Brazil, Portugal and other countries for chronic pain treatment but has not been approved for use in the United States. In 2008 the Food and Drug Agency (FDA) granted permission to conduct clinical research of Effirma to explore its use as a primary pain management tool for the treatment of fibromyalgia. It appears that Synthetic Biologics is somewhere between phase II and phase III trials in the progression of Effirma development. It is thought that Effirma provides pain relief through interaction with non-opiate neural pathways in the nervous system.
TNX-102 is a sublingual (SL) or under-the-tongue tablet at a novel dose, a technology that allows rapid delivery of cyclobenzaprine into the body. The tablet quickly dissolves and releases cyclobenzaprine, a widely prescribed muscle relaxant, which is absorbed across the mucous membrane into the patient’s bloodstream. TNX-102 is in development specifically as a treatment for fibromyalgia. In early trials, reductions in musculoskeletal pain, pain sensitivity, fatigue, and altered mood were noted. TONIX expects TNX-102 to enter into pivotal trials in the first quarter of 2013.
Keep watching NFMCPA emails and magazine articles for information updates about these medications.