Treatment in the field of pain has been the concern of multinational pharmaceutical companies, and the face of many gaps in the domestic market, the action of Chinese pharmaceutical companies slightly slow.
Recently, Pfizer announced in Beijing: A new treatment for post-herpetic neuralgia pain market. The generic drug pregabalin, marketed in the United States in 2004, has been approved by the U.S. FDA for post-herpetic neuralgia, diabetic peripheral neuropathies, epilepsy, and fibromyalgia and has been tested in more than 80 countries worldwide Listing in the area.
The pain field is promising. In China, pregabalin is currently approved by the SFDA for only one area of treatment: post-herpetic neuralgia. It is well-known that SFDA has stepped up its control over the registration and approval process due to the increasingly perfect drug regulatory system in our country. All kinds of requirements and norms are becoming more and more stringent.
For new drugs, especially patented drugs in the market for the first time, the choice of the first indication will undoubtedly take more consideration. Beijing Union Medical College Hospital Introduction: Post-herpetic neuralgia occurs in the herpes zoster virus infection, foreign data show that 25% to 50% of patients over 50 years of age infected with herpes zoster suffering from post-herpetic neuralgia, and often Accompanied by sleep disorders, anxiety, depression and other attendant symptoms. Epidemiological survey showed that the incidence of shingles was 1.4% of the population. ~ 2.8%. Between the treatment is not difficult, generally do not have serious consequences such as lethality, be regarded as a relatively high incidence of small ailments.
Pfizer said: "In terms of output, the current analgesic product line has taken a very important position in Pfizer, Pregabalin sales in the world already ranked third." The choice of post-herpetic neuralgia Pfizer certainly does not mean Pfizer's optimism about the pain market as its first indication.
It is understood that pregabalin indications initially registered are: peripheral neuropathic pain in diabetes, post-herpetic neuralgia, followed by epilepsy studies and indications for approval, generally classified as anticonvulsant drugs. Pregabalin was approved by the FDA for use in the treatment of fibromyalgia in June 2007, and is by far the only anticonvulsant approved for the treatment of fibromyalgia. Because pregabalin has a very strong analgesic effect with few adverse effects, it has become a leader in anticonvulsants for the treatment of neuropathic pain.
It is known that pregabalin is included in the first-line medicines for the treatment of neuropathic pain, such as the European Neurological Society's Union Guideline, the American College of Neurology, the National Institute of Health and Clinical Excellence, and the list of therapies And gabapentin.
Gabapentin, like pregabalin, is a calcium channel regulator and is also Pfizer's original research drug and did not enter China early. Later patent expired, China successfully copied gabapentin in 2003.
However, gabapentin, which had achieved good global performance of $ 2.8 billion in 2005, should have a more optimistic outlook