Usually people affected by TMD are between 20 and 40 years of age, and it is more common in females than males. TMD is the second most frequent cause of orofacial pain after dental pain (i.e. toothache). Classification
TMD is considered by some to be one of the 4 major symptom complexes in chronic orofacial pain, along with burning mouth syndrome, atypical facial pain and atypical odontalgia. TMD has been considered as a type of musculoskeletal, neuromuscular, or rheumatological disorder. It has also been called a functional pain syndrome, and a psychogenic disorder. Others consider TMD a "central sensitivity syndrome", in reference to evidence that TMD might be caused by a centrally mediated sensitivity to pain. It is hypothesized that there is a great deal of similarity between TMD and other pain syndromes like fibromyalgia, irritable bowel syndrome, interstitial cystitis, headache, chronic lower back pain and chronic neck pain. These disorders have also been theorized to be caused by centrally mediated sensitivity to pain, and furthermore they often occur together. Definitions and terminology
Frequently, TMD has been treated as a single syndrome, but the prevailing modern view is that TMD is a cluster of related disorders with many common features. Indeed, some have suggested that, in the future, the term TMD may be discarded as the different causes are fully identified and separated into different conditions. Sometimes, "temporomandibular joint dysfunction" is described as the most common form of temporomandibular disorder, whereas many other sources use the term temporomandibular disorder synonymously, or instead of the term temporomandibular joint dysfunction.
Sanofi resubmitted the application which the FDA accepted in September 2015, by which time Sanofi had lost the lead in the field of anti-diabetic drugs to Novo Nordisk. Lixisenatide received FDA approval on July 28, 2016.In 2010, Sanofi extended a license agreement it had with Zealand for lixisenatide to allow Sanofi to combine it with insulin glargine, which was Sanofis best selling drug at the time, with sales of around €3 billion in 2009. Sanofi planned to start the Phase III trial that year. Sanofi submitted the new drug application in December 2015 for the combination and spent a US$245M priority voucher to gain a faster review, to try to outrace Novo Nordisk’s Xultophy, a similar combination drug of Novos insulin Tresiba and Novos GLP-1 agonist Victoza. Sanofis application was considered by the same Endocrinologic and Metabolic Drugs Advisory FDA Committee that was considering lixisenatide as a single agent. In May 2016 by a vote of 12–2, with several members of the committee expressing reservations about Sanofis plans to offer two pens with different ratios of insulin glargine and lixisenatide - one for people who had never taken insulin before and one for people who had; there was also concern about how to handle dosing when switching people from a single drug regimen to the combination drug. In August 2016 the FDA told Sanofi that it was delaying a final decision for three months, and asked Sanofi for more data on how people used the delivery devices.