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    Home > Active Ingredient News > Drugs Articles > Wei myalgia medication domestic vacancy, who can pull out the top?

    Wei myalgia medication domestic vacancy, who can pull out the top?

    • Last Update: 2016-03-17
    • Source: Internet
    • Author: User
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    Source: medical economics report 2016-03-17: fibromyalgia syndrome (FMS) is a non joint rheumatic disease with unknown etiology The patient is characterized by chronic extensive musculoskeletal pain and stiffness, accompanied by fatigue, anxiety, sleep disorders, intestinal stress syndrome and other symptoms It was not until 1990 that the American rheumatology Society (ACR) named the disease "fibromyalgia syndrome" and proposed a unified diagnosis and treatment standard, which was widely accepted in the world According to ACR classification criteria, FMS is defined as diffuse chronic pain lasting for more than 3 months, involving both sides of the body and the upper and lower parts of the waist Among the 18 special tenderness points, more than 11 tenderness points are enhanced Arnold has emphasized that the average delay time of diagnosing FMS patients is 5-7 years The failure to obtain timely and correct diagnosis not only brings continuous pain and mental pressure to patients, but also increases the medical cost significantly General situation: according to the 1990 ACR classification criteria for FMS diagnosis, there are about 3-6 million FMS patients in the United States, accounting for about 2% of the total population, and the prevalence rate of men and women is 0.5% and 3.4% respectively The prevalence of FMS increased with age FMS accounted for 15.17% of rheumatic diseases, ranking third after OA and RA At present, the cognition of FMS in China is relatively low A survey on the cognition of rheumatologists to FMS in China from Peking University People's hospital shows that only about one third of doctors know the diagnostic criteria of FMS formulated by ACR in 1990, and the awareness rate of other aspects such as treatment and pathogenesis is lower; the cognition degree of rheumatologists in China to FMS is significantly lower than that in Britain and Southeast Asia Although there is no exact epidemiological data of FMS in China, it is predicted that the prevalence of FMS in China is not low based on the large population base In recent years, people's understanding of FMS has made a breakthrough More and more evidences show that the onset of FMS is related to the abnormal neurochemical processing of sensory signals by CNS, but FMS is still the most difficult chronic pain disease to be diagnosed and treated so far Once the FMS is confirmed, it is very important to educate the patients, to comfort and explain the patients, so that they can understand the disease situation of FMS, without any damage to internal organs, and can get effective treatment, without serious deterioration or fatal Although the patients with FMS can get pain relief through cognitive behavior therapy, water bath therapy, functional exercise, acupuncture, massage, low frequency electrotherapy and local pain point sealing and other non drug treatment methods, drug therapy is still the main treatment There are few approved drugs for treatment of FMS There are antidepressants such as amitriptyline, fluoxetine, sertraline, paroxetine, duloxetine hydrochloride, minapram hydrochloride, moclobemide, etc.; muscle relaxants such as cybenzolin; antiepileptics such as pregabalin; analgesics such as tramadol; anti Parkinson's drugs such as pramipexole hydrochloride; sedatives such as zolpidem and zopiclone; antiemetics such as tropisetron, etc However, only pregabalin, duloxetine hydrochloride and minapram hydrochloride have been approved by FDA for the treatment of FMS Among them, pregabalin is the first FMS treatment drug approved by FDA Variety pregabalin: the approved FMS indications will be available soon Pregabalin was developed by Pfizer in the United States and approved by FDA in December 2004 The product name is "lycrica" The approved dosage forms are capsule and oral liquid Among them, the capsule specifications are 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg, and the oral liquid specifications are 20mg / ml In the United States, the approved indications of pregabalin include postherpetic neuralgia (PHN), diabetic peripheral neuralgia (DPN), fibromyalgia syndrome (FMS), neuropathic pain caused by spinal cord injury, and adjuvant treatment of partial seizures in adult patients Among them, the dosage for treatment of FMS is 300mg / day, and the maximum dosage is 450mg / day, which is taken twice In addition, the European EMA approved pregabalin in March 2006 for the treatment of generalized anxiety disorder (GAD) Pregabalin is a kind of γ - aminobutyric acid analogue, which was originally designed for the treatment of partial epileptic seizures Because of its therapeutic effect on neuropathic pain and other central nervous system diseases gradually found in subsequent clinical studies, pregabalin was developed for the treatment of pain related diseases The results of preclinical studies show that pregabalin can effectively control neuropathic pain by inhibiting the α 2-δ protein of voltage-dependent calcium channels in the central nervous system, reducing the influx of calcium ions, thereby reducing the release of excitatory neurotransmitters such as glutamate, noradrenaline, substance P, etc The results of clinical study showed that prabalin with a daily dosage of 300-450 mg could effectively treat FMS, relieve pain, improve sleep, relieve fatigue, improve quality of life, and had good tolerance CFDA has approved Pfizer's pregabalin capsule to be imported into China in July 2010, with specifications of 25mg, 50mg, 75mg, 100mg, 150mg, 200mg and 300mg The approved indications are post herpes zoster pain In addition, CFDA approved pregabalin capsule (trade name: lerek) produced by Chongqing Saiwei Pharmaceutical Co., Ltd in June 2013, with specifications of 25mg, 75mg and 100mg, indicating partial epilepsy in adults At present, Chongqing Saiwei's pregabalin capsule is the exclusive product in China Although there are two different brands of pregabalin in China, neither Pfizer, the original research company, nor Chongqing Saiwei's pregabalin capsule has been approved for fibromyalgia treatment It is worth mentioning that Pfizer has carried out clinical trials of pregabalin for the treatment of FMS and DPN in China The trial registration numbers are ctr20132965 and ctr20132973 respectively It can be seen that the approval of treatment of FMS in pregabalin, China is just around the corner In view of its superior clinical efficacy, pregabalin was rated as one of the "top ten medical advances in 2007" by time in 2007 The birth of pregabalin pioneered the treatment of FMS in the medical community With the expansion of indications and in-depth understanding of the medical community, pregabalin has become one of the best-selling drugs in the world According to the data from IMS, in 2014, the global sales of pregabalin reached US $5.1 billion, an increase of 12% year on year The United States alone has a sales volume of US $2.985 billion, accounting for more than half of the global market share Duloxetine hydrochloride: good performance in the domestic market The drug was developed by Lilly in the United States, and was approved by the FDA in August 2004 Its trade name is Cymbalta The approved dosage forms are enteric coated capsules with specifications of 20mg, 30mg and 60mg In the United States, duloxetine hydrochloride was first approved for severe depression (MDD), and then approved for the treatment of GAD, DPN, FMS and chronic musculoskeletal pain Duloxetine hydrochloride is the second FDA approved drug for the treatment of FMS, which was approved in June 2008 The initial dose of duloxetine hydrochloride for the treatment of FMS is 30mg / day, the target dose is 60mg / day, once a day Duloxetine hydrochloride is a dual inhibitor of 5-hydroxytryptamine (5-HT) and noradrenaline (NE) reuptake It plays an analgesic role by inhibiting the reuptake of 5-HT and NE, which is similar to amitriptyline The results of clinical study showed that duloxetine hydrochloride could significantly reduce the number of tenderness points, increase the mean value of tenderness point pain threshold, and significantly improve the cgiis CFDA has approved Lilly's duloxetine hydrochloride enteric coated capsules for the first time to be imported into China in October 2009, with specifications of 30mg and 60mg Currently, duloxetine hydrochloride has been approved for indications of depression and generalized anxiety disorder in China Duloxetine hydrochloride has been localized, but the approved indications are depression Therefore, duloxetine hydrochloride has not been approved by CFDA for the treatment of FMS According to IMS data, duloxetine hydrochloride's global sales reached a peak of 5.2 billion US dollars in 2013 However, due to the impact of the patent cliff, its global sales declined in 2014 Different from the global market, duloxetine hydrochloride Market performed well in China In 2014, xinbaida's sales in China reached 360 million yuan Minapram hydrochloride: milnacipran hydrochloride, a domestic brand, was first developed by Pierre Fabre medicament in France and listed in France in 1997 It is clinically used to treat depression Subsequently, pirfarber pharmaceutical company transferred minopram hydrochloride to cypress company In January 2009, minopram hydrochloride was approved by FDA for the treatment of FMS, and the trade name was "savella" The approved dosage forms are tablets with specifications of 12.5mg, 25mg, 50mg and 100mg The initial dose of minopram hydrochloride in the treatment of FMS was 12.5mg/day, and it reached 100mg / day after 7 days Patients with renal insufficiency need dose adjustment Minopram hydrochloride is the third FDA approved drug for the treatment of FMS Minapram hydrochloride is a selective 5-HT and NE reuptake inhibitor The drug improves fibromyalgia symptoms through dual inhibition of 5-HT and NE reuptake The results of clinical study showed that compared with placebo, menapram hydrochloride 100mg / day or 200mg / day could significantly improve the pain, overall evaluation and physiological function of patients with FMS CFDA has approved the 25 mg minapram tablet produced by Shanghai Modern Pharmaceutical Co., Ltd in May 2010, which is used to treat depression clinically At present, Shanghai Hyundai pharmaceutical's minapram hydrochloride is the exclusive product in China It is reported that Pierre Faber pharmaceutical company of France has applied to CFDA for the import registration of this product in December 2008 and obtained the clinical approval in May 2011 However, there is no detailed information about the clinical trials of the original research company in China at present In conclusion, minapram hydrochloride has not been approved for treatment of FMS in China It is worth mentioning that in February 2015, Shanghai Hyundai Pharmaceutical Co., Ltd filed a registration application for minopram hydrochloride tablets (acceptance No.: cxhl1401622 and cxhl1401623) to CFDA in 3.4 categories, so as to speculate that the indication of this registration application of Shanghai Hyundai Pharmaceutical Co., Ltd is fibromyalgia Conclusion: up to now, FDA has only approved pregabalin, duloxetine hydrochloride and minapram hydrochloride for the treatment of FMS Although all three drugs have been approved by CFDA
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