The development of the psychopic drug ketamine, which has been on the market for decades, is still on the way!

the | Drug mad depression, the global prevalence rate has been as high as 3% to 5%, especially severe depression, after the full course of treatment of the drug is still 30% of the difficult to treat depression, so the current clinical needs are still seriously needed! Antidepressants are also emerging as a result! Among the many drugs on the market, it is worth mentioning the variety, when (Ace) ketamine, after decades of clinical use, finally in 2019 through the improvement of dosage forms and officially turned to the field of antidepressants, and become the world's only fast-acting antidepressants, causing widespread concern in the industry! Ketamine hydrochloride was listed 50 years ago in February 1970, par Sterile Products (Endo subsidiary) developed ketamine hydrochloride hydrochloride (a cyclohetogen derivative), approved by the U.S. FDA for clinical use in anesthesia, the commodity named Ketalar ®.
the species was originally synthesized by Stevens in 1962, first used in humans by Corssen and Domino in 1965, and clinical trials of pain, depression and schizophrenia have been conducted in addition to approved anaesthetic adaptations.
Figure 1.1 Signaling path of the effect of ketamine on NMDA in mood disorders Source: AstraDamine 2019 Challenge Depression August 1997, as a right-hand isomer of ketamine, Acetaminosterone hydrochloride was approved for sale in Germany under the trade name Keesttan®, an intravenous agent for anesthesia and analgesics.
PS: Intravenous ascetamine is highly addictive and can be difficult for doctors in clinical practice, so it is extremely important to choose a safe and effective method of use.
March 2019, the S-ketamine nasal spray developed by Johnson and Johnson was approved in the United States as the world's only fast-acting antidepressant, and in December 2019 it was approved by the EMA under the name Spravato ®.
The approval was based on the results of a Phase III clinical trial involving more than 1,700 adult TRD patients, which showed that in short-term studies, patients in the Spravato treatment group had significantly improved depressive symptoms during the fourth week of treatment compared to the placebo-combined oral antidepressant group, and that in long-term studies, Spravato combined treatment reduced the risk of recurrence by 51 percent compared to patients who maintained a placebo and oral antidepressant program.
In addition to the above information, Acetamine hydrochloride has been recognized by the FDA for two breakthrough therapies, including the treatment of drug-resistant depression (November 2013) and severe depression at risk of suicide (August 2016).
addition, its drum chamber-injected gel preparation (for the treatment of tinnitus) is currently in Clinical Phase III and was awarded fast track by the FDA in July 2016.
The development of
ketamine compound varieties in addition to the above-mentioned ketamine/ ascetamine and its different dosage forms, for ketamine compound preparations, there are also varieties into development, and mainly concentrated in EpiCept company developed amitin/ketamine, aminobenzene/ketamine.
➤ Amithylin/ketamine is a compound drug consisting of 5-serotonin reuptake/dethynephrine reuptake inhibitors (amitin) and ketamine, originally EpiCe pt (acquired by Immune in August 2013) was developed and a cooperation agreement was reached with National Cancer Institute, which is currently in the clinical Phase III trial phase for the treatment of exosytopathy, pain, neurotoxicity and unspecified adult solid tumors.
PS: In 2010, amithylin/ketamine was recognized by the FDA as an orphan drug for treating nerve pain after shingles, and in 2012, the FDA granted amritillin/ketamine a fast-track approval channel for the treatment of peripheral nerve pain caused by chemotherapy.
➤ The aminophenylphenidate/ketamine variety is a compound consisting of sodium ion channel antagonists (aminobenzene butylate) and ketamine, also developed by EpiCept, for the treatment of adaptive neuropathic pain that was previously in clinical phase I/II.
Domestic ketamine-related clinical application statistics, in recent years, more attention to nasal spray dosage form (whether S-form or R-configuration), are currently in the clinical stage, the number of trials is small, and no varieties have been approved for production;
Table 4.1 Domestic clinical trials related to ketamine in the last 5 years "in-process/completed" domestic ketamine-related registration declaration statistics, ketamine-related product registration declaration, mainly the following varieties, namely, "ketamine hydrochloride injection", "ketamine testing kit", "? Morphine/methamphetamine/ketamine triad test kit, right ketamine hydrochloride injection, hydrochloric acid ascettamin nasal spray, hydrochloric acid ascetamine injection, hydrochloric acid (R)-ketamine nasal spray, etc.
From 2000 to the present, the relevant products have been approved for production of ketamine testing kit developed by Aikang Biotechnology Co., Ltd., morphine/methamphetamine/ketamine tri-in-one test kit developed by Shanghai Kaitron Biotechnology Co., Ltd., and ketamine test kit, Jiangsu Hengrui Pharmaceutical Co., Ltd. developed ascension ketamine hydrochloride.
And further inquiries, for ketamine injections, the domestic market sales enterprises are mainly Fujian Gutian Pharmaceutical Co., Ltd., Jiangsu Hengrui Pharmaceutical Co., Ltd., Shanghai First Biopharmaceutical Pharmaceutical Co., Ltd., Shandong Fangming Pharmaceutical Group Co., Ltd., Shanghai Shanghai Pharmaceutical Co., Ltd., China Resources Shuanghe Pharmaceutical Co., Ltd., and so on.
summary, i.e. brief information on ketamine.
, ketamine in the whole spiritual field is not a very high degree of attention varieties, but its new drugs, market for decades is still developing the process, it is worth learning from us.
because it is not only a boost to currently unsolt clinical needs, but also a combination of the development company's understanding of the variety and related technologies.
the world has now been on the market too many therapeutic drugs, development is not entirely indisputable fact, and from which to find and carry out better secondary development, perhaps also for the enterprise a drug development strategy.
: 1. FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor's office or clinic, FDA, 2019/03.2. official information 4. FDA official website information 5.CDE official website information 6. Drug clinical trial registration and information publicity platform official website