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Efficacy, Quality, Safety and Toxicity of Herbal Medicine
Published in Dilip Ghosh, Pulok K. Mukherjee, Natural Medicines, 2019
In the European Union (EU), HMPs are officially recognised as medicines based on directives set out in 2001 and 2004. On the other hand, in the United States (US), HMPs are still classified as botanical products and are controlled by food legislation due to their chemical complexity. In 2008, the FDA approved its first botanical drug Veregen® (sinecatechins) derived from green tea for application on genital and perianal warts. In 2012, Crofelemer was approved for the symptomatic relief of diarrhoea in HIV/AIDs patients under antiretroviral therapy. Despite the reluctance to register HMPs as official medicine, it is widely recognised today that they can be important alternative sources of medicines for chronic diseases such as cancer and heart conditions. For example Chinese medicine–based PHY906 has passed phase I and II trials for cancer and Dantonic® underwent phase III trial for angina in the United States (Chen et al. 2008; Yen et al. 2008; Fan et al. 2012).
Ion channels as therapeutic antibody targets
Published in mAbs, 2019
Catherine J. Hutchings, Paul Colussi, Theodore G. Clark
To date, most ion channel drug development has focused on identifying and developing small molecule and peptide modulators, mainly through serendipitous discovery due to a lack of information on structure and function. Many ion channel modulators have been discovered from studies of naturally occurring substances, such as toxins from plants and venomous animals.10 The conotoxin family is the most well-known of the animal-derived toxins,11 with ziconotide, a selective Cav2.2 antagonist, a frequently cited example of a synthetic peptide analogue of cone snail ω-conotoxin used for the treatment of severe chronic pain.12 Despite the initial successes in identifying ion channel modulators, only two novel ion channel drugs have been approved by the US Food and Drug Administration (FDA) since the 1990s, despite vastly improved screening tools for small molecule/compound libraries.13 The most recently approved drugs are ivacaftor (Kalydeco), which potentiates the cystic fibrosis CFTR chloride channel14 and crofelemer (Mytesi), a proanthocyanidin oligomer, which inhibits both CFTR and the calcium-activated chloride channel TMEM16A.15 As with the vast majority of other drugs targeting ion channels, ivacaftor and crofelemer are both small molecule chemical entities.16
How can we improve the safe use of herbal medicine and other natural products? A clinical pharmacologist mission
Published in Expert Review of Clinical Pharmacology, 2020
Elena Y. Enioutina, Kathleen M. Job, Lubov V. Krepkova, Michael D. Reed, Catherine M. Sherwin
Botanical drugs are often extracts prepared medicinal plants, algae, and/or macroscopic fungi (Figure 1) [4]. Highly purified or chemically modified NP constituents are not considered to be botanical drugs and are classified as conventional drugs. The pharmacological properties of a botanical drug cannot always be ascribed to a specific constituent. Furthermore, the pharmacological effects of botanical multi-constituent drugs are most likely the result of the combined activity of all constituents present in the extract. Specific recommendations for botanical drug production, safety, and efficacy testing were clarified in a ‘Guidance for Industry: Botanical Drug Products’ initially published by the Center for Drug Evaluation and Research Botanical Review team in 2004 and revised in 2016 [1,5]. The U.S. FDA has received > 800 IND and PINDs in the last 34 years [5]. The marketing of botanical drugs is labor-intensive and expensive [5,20]; therefore, only two botanical drugs have currently fulfilled the directives given in the Guidance for Botanical Drugs (i.e. Veregen® (sinecatechins) ointment and Mytesi® (crofelemer)) [2,5]. Veregen® (sinecatechins) is a water extract of green tea leaves from Camellia sinensis (L.) intended for the cutaneous treatment of external genital and perianal warts in immunocompetent patients aged ≥18 years [21]. The extract consists of eight known catechins (i.e. Epigallocatechin gallate, Epicatechin, Epigallocatechin, Epicatechin gallate, Gallocatechin gallate, Gallocatechin, Catechin gallate, and Catechin) and other constituents such as gallic acid, caffeine, and theobromine. Crofelemer is a botanical drug isolated from the red sap of the Croton lechleri tree intended for symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy [22].
Drug development and acute gastrointestinal infections
Published in Expert Opinion on Investigational Drugs, 2018
Hania Szajewska, Maciej Kołodziej, Jan Łukasik
One of the novel antisecretory drugs is crofelemer. It prevents chloride (Cl-) and fluid secretion into the lumen by inhibiting the cystic fibrosis transmembrane conductance regulator (CFTR) Cl- channel and the calcium-activated Cl- channel (CaCC). Currently, crofelemer is only approved for the management of noninfectious diarrhea in HIV/AIDS patients receiving antiretroviral therapy [8].