New drug development infernal: new drugs from drugs
New drug development infernal: new drugs from drugs December 29, 2017 Source: US source of medicine: Lu Renbing news Today, British pharmaceutical company GW Pharmaceuticals announced that the FDA has accepted its market application for the cannabisdiol (CBD) liquid preparation Epidiolex for rare epilepsy Lennox-Gastaut (LGS) and Dravet syndrome. This application is a priority approval, and the PDUFA date is June 27 next year. In addition, Johnson & Johnson today published a phase II clinical trial of its dextrorotatory ketamine. Three doses of dextran ketamine administered nasally per week significantly relieved depressive symptoms compared with placebo, and the dose-effect relationship was significant. The three-phase clinical outcome of this product is expected to be announced in the first quarter of next year. Drug source analysis Ketamine is a 60-year-old drug. Around 2000, Yale scientists found that low-dose (<1 mg/kg), short-term (<1 hour) infusion of ketamine can quickly relieve depressive symptoms, and the duration of treatment far exceeds the drug half-life. However, intravenous drip is inconvenient to use, so both Johnson & Johnson and Turing developed a new dosage form for nasal administration. Ketamine is a racemate and Johnson & Johnson is one of the enantiomers. This method of extending the life of the product with enantiomers was popular in the 1980s and 1990s, but no one has done it yet. The phase III clinical trial of racemic ketamine supported by other institutions will also end next year. The antidepressant mechanism of ketamine is quite complicated. The mainstream view is that antidepressant comes from NMDA partial agonist activity, but many other theories, such as active metabolites, also have some experimental basis. In 2006, an executive at Baxter and a professor at Northwestern University jointly established Naurex according to the NMDA hypothesis, and found a new NMDA receptor agonist raspastel, which was later acquired by Alcon 560 million. Both Rapastinel and D-Ketamine have achieved FDA breakthrough drug status. Although cannabis has been used as a drug for thousands of years, it has not been approved by the FDA, and its public identity is still a drug. As early as the 19th century, people used cannabis to treat epilepsy. Many large pharmaceutical companies had a cannabis product line 100 years ago (pre-FDA era). CBD is one of the main components of hundreds of active ingredients in cannabis, but there is no other pleasant component, tetrahydrocannabinol (THC), which is pleasant and illusory. Last year, the CBD showed clinical efficacy in the three phases of LGS and Dravet, two super-refractory and super painful epilepsy, which made such children and their families see a glimmer of hope. If the listing is going to be a drug that really comes from drugs. All drugs have toxic side effects, but it is clear that drugs may also have a therapeutic effect. Both marijuana and ketamine are common drugs, and if used for a long time, drugs can be found in drugs. Another promising Dravet drug is Zogenix's low-dose fluoroamphetamine formulation ZX008. Although fenfluramine was once a listed diet pills, it turned out to be a semi-drug with more toxicity than efficacy. Sage's galenosterone analog, although not a drug, may treat both epilepsy and depression. Unfortunately, although the pregnenolone derivatives produced significant effects in different depressed populations, they failed clinically in the third phase of severe epilepsy. In addition to the many functions of some proteins, an important factor is the so-called network pharmacology. Selectivity is a double-edged sword. The beneficial and harmful pharmacological effects are linked by poorly selective drugs, and there are many insignificant gray areas in the rivers and lakes. Evaluation and optimization systems that go to the rough and clear, right and wrong are crucial to the discovery of new drugs. 　　 Original: https: //mp.weixin.qq.com/s __biz = MzAxMTgxNzc5MQ == & mid = 2650312318 & idx = 1 & sn = 053e3e85d88b2d653328689395eb9443 & chksm = 83b7682eb4c0e138572d8b822cdb1f0e76b70f34036d5841f3000c467cbc58da9774d3d05e42 & mpshare = 1 & scene = 1 & srcid = 1229cB6FAEegeZnPvBn1FVhe # rd? medical products Anesthesia Medical Co., Ltd. , https://www.jssinoanesthesia.com