PHARMA LITERATI

Pharma Literati - Newbie A new initiative to understand the chemistry, pharmacokinetics, dosage form details, dosing regimen, indication of newly approved drugs by USFDA. Watch the Third video for Ivosidenib at:   https://www.youtube.com/watch?v=Cr8hAEtsTiM

Patients who go off opioid painkillers face excruciating withdrawal symptoms such as anxiety, nausea, vomiting, insomnia, muscle aches and more. Now, thanks to an FDA approval for US WorldMeds' Lucemyra, they'll have the first drug designed to fight those symptoms. Lucemyra won its FDA nod on Wednesday based on two trials showing that the drug reduced severe withdrawal symptoms better than placebo. Plus, more patients in the Lucemyra arm completed a seven-day opioid discontinuation treatment. Used for more than two decades in the U.K., the oral drug isn't meant to treat opioid addiction or curb drug cravings. But it can be used as part of a long-term plan for quitting the powerful painkillers and staying opioid-free long-term, the FDA said. For instance, Lucemyra could be a springboard into a long-term medication-assisted addiction therapy such as Vivitrol (naltrexone), an Alkermes drug that blocks the effects of opioids on the brai...

The U.S. Food and Drug Administration today approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide , a molecule that is involved in migraine attacks. " Aimovig provides patients with a novel option for reducing the number of days with migraine ," said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. " We need new treatments for this painful and often debilitating condition. " Patients often describe migraine headache pain as an intense pulsing or throbbing pain in one area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Approximately one-third of affected individuals can predict the...

Source:  https://www.patexia.com/feed/22-novel-drugs-approved-by-fda-in-2016-20170131

Fevipiprant trial indicates it could halve patients’ risk of suffering asthma attacks and being admitted to hospital A new asthma drug that could revolutionise the treatment of the 500,000 Britons with moderate or severe versions of the condition and reduce the number of deaths from has been hailed as a “ gamechanger ”. Asthma treatment has barely changed over 20 years, with those who cannot easily control their condition relying on inhalers or using steroids which carry a high risk of weight gain, diabetes, osteoporosis and high blood pressure. The development of the drug, called Fevipiprant , opens up the possibility that the 250,000 people with this more severe form of the disease could now take a pill twice a day instead of relying on those methods. It could also benefit at least another 250,000 people who have the more moderate form of the disease. The expert in severe breathing conditions who oversaw the latest trial of the drug said its potential effectiveness...

A green revolution is underway at one of the world's longest laboratories located deep inside BARC's Anushakti Nagar complex near Chembur. Scientists at the 700-metre modular laboratory in BARC are using Indian herbs and spices to develop anti-cancer and other drugs that will be affordable and have fewer side-effects. Rampatri-better known as `false nutmeg' and widely used in Goan and Mangalorean cuisine--is a case in point. Scientists from BARC's bio-science group have developed a chemotherapeutic drug that has, in studies on mice, shown potency against lung cancer and neuroblastoma (a rare pediatric cancer in which cancer cells grow in the nerve cells of the adrenal glands, neck, chest, and spinal cord). “This is a significant development as neuroblastoma treatment is aggressive and the disease is known to recur,” said Dr S Chattopadhyay, who heads the bio-science group. The herbal drug developed reduces the tumor burden while increasing the efficacy of...

Merck's Keytruda gets DCGI nod, Bristol-Myers Squibb's Opdivo secures clinical trial waiver Cancer patients in India are set to gain faster access to two of the world's best known new generation drugs ­ Keytruda from US-based Merck and Bristol-Myers Squibb's Opdivo ­ both used to treat melanoma, a form of malignant skin cancer and a life-threatening lung cancer. According to a top health ministry official, while Keytruda has recently been granted approval by the Drug Controller General of India (DCGI) in line with recommendations of expert oncologists and a powerful apex committee, Opdivo has secured waiver from clinical trials a few months ago, paving the way for its marketing authorization. The accelerated regulatory clearances cut the time lines for introductions of the two big brands which may be expected to be introduced by the end of the year, market sources indicated. Ever since their approvals by the US FDA in 2014, the two drugs have set new ...

BBC reports that a new gene therapy base drug has been approved recently. Please see: http://www.bbc.com/news/science-environment-36400206 Regulators have given one of the world's largest drug companies approval to sell a new gene therapy. The treatment is for an illness called ADA-SCID which prevents babies from fighting off everyday infections. This is the  first approval for a genetic therapy  granted to a large multinational drug company, GSK. Commentators say the development marks the beginning of many more genetic medicines from so-called "Big Pharma". The condition is extremely rare and affects around two dozen babies each year. Approval of the gene therapy paves the way for the development of treatments for more widespread illnesses such as thalassemia and sickle cell disease. Hundreds of inherited disorders such as cystic fibrosis, muscular dystrophy and many types of blindness are caused by faulty genes. Hype: The aim of gene therapies is t...

Drug Name K-134 Structure   Drug Code K-134 Synonym OPC-33509 1-cyclopropyl-1-(2-hydroxycyclohexyl)-3-[3-[(2-oxo-1H-quinolin-6-yl)oxy]propyl]urea Molecular Formula C 22 H 29 N 3 O 4 Innovator D. Western Therapeutics Institute Kowa Company, Ltd. Condition Arteriosclerosis obliterans Mechanism of Action Type 3 cyclic nucleotide phosphodiesterase inhibitors (PDE3 inhibitor) Clinical Phase IIb in US

Drug Name Vernakalant Structure   Drug Code RSD1235 Synonym Kynapid, Brinavess (3R)-1-{(1R,2R)-2-[2-(3,4-dimethoxyphenyl)ethoxy] cyclohexyl}pyrrolidin-3-ol Molecular Formula C 20 H 31 NO 4 Innovator Cardiome Pharma Corp Merck Condition Prevention of post-operative atrial fibrillation in patients undergoing coronary artery bypass graft surgery. Mechanism of Action Blocks atrial potassium and sodium channels Clinical Phase Not yet approved. (Filed for Orphan Drug Designation) Approved in Europe.

Drug Name Etripamil Structure   Drug Code MSP-2017 Synonym methyl 3-(2-{[(4S)-4-cyano-4-(3,4-dimethoxyphenyl)-5-methylhexyl](methyl)amino}ethyl)benzoate Molecular Formula C 27 H 36 N 2 O 4 Innovator Milestone Pharmaceuticals Condition Acute episodes of paroxysmal supraventricular tachycardia Mechanism of Action Calcium channel antagonist (Intranasal) Clinical Phase II in USA

Drug Name Eleclazine Structure   Drug Code GS-6615 Synonym 4-(pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy) phenyl]-2,3-dihydro-1,4-benzoxazepin-5-one Molecular Formula C 21 H 16 F 3 N 3 O 3 Innovator Gilead Sciences Condition Cardiomyopathy Mechanism of Action Sodium channel antagonists Clinical Phase III in USA

Let’s continue our series of Future of Drugs. We are now going to take you through the new drugs that are being developed and those that might actually get approved against the rising incidence of Heart Diseases and Stroke. Ciraparantag has tremendous potential of competing with anticoagulants like edoxaban, rivaroxaban, dabigatran and apixaban. Ciraparantag is to be administered IV.  Drug Name Ciraparantag Structure   Drug Code PER 977 Synonym Aripazine N,N'-(1,4-piperazinediyldi-3,1-propanediyl)bis[2-amino-5-[(aminoiminomethyl)amino]-, (2S,2'S)-pentanamide Molecular Formula C 22 H 48 N 12 O 2 Innovator Perosphere Condition Anticoagulant Reversal Mechanism of Action Blood coagulation factor modulators; Factor Xa inhibitors Clinical Phase II in USA (Fast Track Designation)   ...